clinical and technical evidence chex surgical staplers latest update

CLINICAL AND TECHNICAL EVIDENCE CHEX SURGICAL STAPLERS LATEST UPDATE APRIL 2010 CONTENTS INTRODUCTION ...................................................................................................................................... 2 SECTION 1. CLINICAL VALIDATION ......................................................................................................... 3 Clinical Studies .................................................................................................................................... 3 Clinical Studies Europe .................................................................................................................... 3 Clinical Studies China ...................................................................................................................... 4 SECTION 2. TECHNICAL VALIDATION ..................................................................................................... 5 APPENDIX A. ........................................................................................................................................... 8 Professor Yves Panis France ............................................................................................................... 8 Professor Giuliano Reboa Italy ......................................................................................................... 25 Professor Kupcsulik, Péter K. Hungary ............................................................................................. 40 APPENDIX B. ......................................................................................................................................... 41 Dundee University. Dr. Stuart Brown. .............................................................................................. 41 1
INTRODUCTION Frankenman international understand the need to provide customers with defendable evidence of their products clinical efficacy and safety. To this end Frankenman have invested and will continue to invest in the conducting of ethical, peer reviewed, clinical studies and evaluations to support the continued improvement and expansion of the Chex product range. In addition to this formal evidence the continued and expanding body of surgeons, institutions and hospitals using the Chex range to treat their patients, on a daily basis, is also a strong validation of our products that should be taken into account. This document will provide a summary of our formal evidence so far and will be divided into clinical and technical validation elements. In addition to these more formal elements the list of users of the Chex range of products is growing and now includes customers in every continent of the world. I have attached a review of case studies from 4 centres in Europe to give examples of the level of satisfaction on Chex Surgical staplers. 2
SECTION 1. CLINICAL VALIDATION Frankenman International have invested in a comprehensive and ongoing clinical evaluation program in all key markets within which they operate. Working with leading centres and surgeons these studies have ranged from straight comparisons between ours and competitive products to establish clinical efficacy and safety through to studies designed to highlight clinical advantages of the Chex range of products. Clinical Studies The following represents a list of studies outside of those undertaken for regulatory or non‐formal evaluation of the Chex range of products. See Appendix A for examples of Study most recent clinical study Clinical Studies Europe Clinical Study Program Europe/USA Country 1 France 2 Italy 3 Hungary Principle Investigator
Products Cases Prof. Yves Panis Circular Staplers 54 patient Case Controlled study Accepted for Publication Colorectal Disease 2010 Feb 20 CPH 30xCPH, 30xPPH03, comparative study
Published Italian Journal of Surgery December 2009 CS, LS, LC 136 patient observation study Published Hungarian Journal of Surgery. 2010 CPH Comparative study for 25 CPH/PPH03 each Accepted for Publication. British Journal of Colon and Rectal Surgery. March 2010 CSCompact
APPEAR Study Commenced January 2010 Study Commenced January 2010 Prof. Giuliano Reboa Prof. Kupcsulik. 5 Switzerland Dr. med. D. Dindo, 6 United Kingdom Professor Norman Williams 7 Hungary Professor Dr Csekeő Attila, Dr Kecskés László LC/LS Thoracic hospital 8 Germany Dr. Jungen CPH 9 Germany Surgeon Group CPH 10 Brazil Bariatric society LC Multi‐center (10) study CPH in day surgery setting Comparative study LC/ Ethicon TLC Situation To be published. Under preparation/negotiation
Under preparation 3
Clinical Studies China 11 12 13 14 15 16 17 18 19 China Jin Chunming, Mao Jiesong, Fan Chunshen China Wang Yongqiang, Wang Zhenyi etc. China Chen Shuang, Lai Dongming, Zhou Taicheng, Zhang Li, Wu Yongquan China Li Bo, Huang Tangjian, Liu Li China China China He Qunfeng, Zhou Xile Feng Zhaowei Cui Junhui, Zhou Xile etc. China Cui Junhui, Zhou Xile, Wang Wenling etc. China Cui Junhui, Zhou Xile etc. CPH Investigation of Clinical Application of Combined PPH with Other Operations (104 cases) Published Chinese Anal‐
colorectal surgery 2006
CPH 50(100) Clinical observation on treatment of grade III internal haemorrhoids by circular resection of low rectum mucosa Published Med J of Communications, 2007, Vol. 21. No. 2 CPH 226 (Ethicon=90, Frankenman=136)T
herapeutic analysis of 226 cases with severe hemorrhoids treated by PPH Published Lingnan Modern Clinics in Surgery, Dec. 2005 Vol.5 No.4 CPH 46 Analysis Report of 46 cases with haemorrhoids treated by PPH Published Clinical and laboratory magazine Dec. 2007 Vol. 6, No. 12
CPH 47 (Frankenman=25 cases, Control Group = 22 cases)Long term result of internal rectal prolapse treated by PPH Published Zhejiang Clinical Medical Journal, 2007 Vol. 9, Issue 10 CPH 55 vs 68 Clinical Analysis of Procedure for Hemorrhoids and Prolapse for Aged Patients with Third‐
degree or Fourth‐
degree Prolapsing Hemorrhoids Published Chinese Journal of Surgery CPH 40 Prospective study of the treatment of severe mixed hemorrhoids with PPH Published Chinese Journal of Surgery CS/LS 152 Prevention and Treatment of Anastomotic fistular after Sphincter Preserving Surgery with Double Stapling Technique
Published Clinical Medical Journal of China, 2006, Vol.13, No.2 CS 103 Comparison of Three Placements Methods of Circular Stapler Anvil Published Zhejiang Clinical Medical Journal, Dec. 2006, Vol.8, Issue 12 4
SECTION 2. TECHNICAL VALIDATION Prior to international launch of our product in Mid 2006 a thorough technical validation of our products was undertaken by Dundee University, Scotland. Dundee University aligned to Ninewells hospital has a world leading Medical Engineering faculty aligned to the Department of Surgery and Molecular biology, led by Sir Alfred Cushieri. Their technical and clinical experience in surgical stapling and anastomosis is unrivalled internationally. APPENDIX B shows a synopsis of their evaluations and a full report is available upon request but their study focussed on several areas such as Leakage and Burst Pressure of staple lines in an animal model and quality of manufacture and functionality in comparison to the market leading devices from Ethicon Endo Surgery (J & J). Below are the key elements extracted from the Dundee Study related to leakage and burst pressure in an animal model and comments on overall quality of construction and functionality. 5
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APPENDIX A. Professor Yves Panis France LAPAROSCOPIC COLORECTAL ANASTOMOSIS USING THE NOVEL CHEXTM
CIRCULAR STAPLER: A CASE-CONTROL STUDY.
L. Maggiori M.D., F. Bretagnol M.D., M. Ferron M.D., Y. Chevalier M.D., Y. Panis M.D.
Ph.D.
Department of Colorectal Surgery, Pôle des Maladies de l’Appareil Digestif (PMAD),
Beaujon Hospital (AP-HP), 100 boulevard du Général Leclerc, 92118 Clichy, France.
Original article
Word-Count: 2,164
Address for correspondence and reprints:
Professor Yves Panis, MD, PhD, Service de Chirurgie Colorectale, Pôle des Maladies de
l’Appareil Digestif (PMAD), Hôpital Beaujon, 100 boulevard du Général Leclerc, 92118
Clichy cedex, France
(Tel +33 1 40 87 45 47; Fax +33 1 40 87 44 31 ; E-mail [email protected])
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ABSTRACT
Aim. The widespread availability of circular stapling devices to perform colorectal
anastomosis has changed surgery especially in laparoscopy. The aim of this study was to
assess the safety and effectiveness of a new circular stapler, the Chex® CS (APVL Medic’s,
Niort, France - Frankenman, Suzhou, China) in terms of operative results and cost.
Methods. From May 2007 to April 2009, a case-control study was conducted including 54
patients who underwent left colonic resection with stapled anastomosis according to the
“double stapling” technique, with the Chex® stapler These patients were matched from a
review board-approved database to 64 similar patients with anastomosis realized with another
device used in our department: the CDH® stapler (Ethicon Endo-Surgery, Inc; Cincinnati,
OH, USA) or the EEA® stapler (Autosuture, Covidien, MA, USA). Matching criteria were
sex, age, BMI, ASA grade, diagnosis, realization of a temporary stoma, and surgical
approach. Primary end-points were post-operative mortality and morbidity. Surgeons were
asked to fill a questionnaire concerning the device ergonomia, using an analogic visual scale.
Results. Mortality was nil. The overall morbidity rate was similar between the two groups.
There was no difference concerning the rate of anastomotic leakages (9% versus 8%, p=1).
Mean overall appreciation was scored 8.1/10 (3-9.5), including best score for stapler
removing (9.5). No major device failure was observed.
Conclusion. This study suggests that colorectal anastomosis using the Chex® circular stapler
is safe without increasing the overall morbidity, especially in terms of anastomotic leakage.
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INTRODUCTION
The technique of transanally introducing a circular stapled device to perform colorectal
anastomosis has been widely used[1-9]. Moreover, recently, the laparoscopic approach in
colorectal surgery has improved the widespread popularity of stapling devices.
Many studies have demonstrated the effectiveness and the safety of such stapling
procedure. A recent French prospective multicentric study concluded that elective colorectal
surgery was associated with a 1 to 2% of mortality rate and a 20 to 40% morbidity rate[10].
Postoperative anastomotic leakage represented the main postoperative complication with
significant clinical implications. A Cochrane review comparing both procedures (i.e. stapled
versus handsewn procedures) for colorectal surgery was insufficient to demonstrate any
superiority of the stapling method over handsewing, regardless of the level of anatomosis[11].
However, besides good results, the major drawback of this stapling procedure remains
related to the cost-benefit ratio[1]. Moreover, the higher costs of laparoscopic equipment
require more financial resources[12]. Despite the potential financial benefit in terms of
improvements in clinical recovery and shorter hospital stay after laparoscopic procedures, the
use of intra-operative cost-effective device could be justified.
The aim of this study was to assess the safety and effectiveness of a new circular stapler,
the Chex® CS (APVL Medic’s, Niort, France - Frankenman, Suzhou, China) in terms of
operative results.
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PATIENTS AND METHODS
From May 2007 to April 2009, we prospectively included 54 patients who underwent
left colonic resection for colorectal cancer and/or benign disease, using the Chex® CS28
circular stapler (APVL Medic’s, Niort, France – Frankenman, Suzhou China) according to
the “double stapling” technique introduced by Knight and Griffen[9].
All patients undergoing colorectal resection in our department are currently included
prospectively into a review board-approved database[10]. Data collection included patients
features (gender, age, body mass index (BMI), American Society of Anesthesiology score
(ASA score), diabetes mellitus, recent steroid treatment, prior laparoscopy or laparotomy,
cardiopulmonary, neurologic and gastrointestinal comorbidities), disease features (diagnosis,
TNM score for colorectal cancer), the surgical procedure (urgent or elective procedure, type
of colorectal resection, anastomosis height, protective stoma, abdominal drainage, associated
procedures, intraopertive peritoneal contamination, technical operative complications, and
operative time), and the post operative results (mortality and morbidity)
Surgical procedure
For laparoscopic patients, the surgical procedure was performed through a total
laparoscopic approach with only a 5-cm incision in the right iliac fossa for both specimen
extraction and, if required, temporary ileostomy.
The technique routinely involved for cancer (in both laparoscopic and open technique):
included high ligation of the inferior mesenteric vessels, complete mobilization of the
splenic flexure and colonic resection according to rectal cancer location (i.e. 5 cm below the
lower edge of the tumor). For benign disease, dissection was made close to the colon and
rectum with sigmoid vessels ligation to avoid nerve injury. Then, the rectum was transected
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using an endoscopic linear stapler and a transanal stapled colorectal anastomosis was
performed, according to the “double stapling” technique[9]. The doughnuts were always
inspected for completeness after anastomosis and anastomotic integrity was tested
systematically during operation by transanal instillation of fluid.
Comparative study
Each patient of the Chex® group was identified from the database and manually
matched with all identical patients from the database in whom anastomosis was realized with
another device used in our department, either the CDH® stapler (Ethicon Endo-Surgery, Inc;
Cincinnati, OH, USA) or the EEA® stapler (Autosuture, Covidien, MA, USA), according to
the individual matching procedure published by Miettinen et al.[13]. Matching criteria were
gender, age (+10%), BMI (+10%), ASA grade, diagnosis, temporary stoma and surgical
approach (laparotomy or laparoscopy). Investigators were blinded to the primary and
secondary end points in both groups during manual matching to reduce bias.
End-points definition
The primary end-points were intra-operative and postoperative complications. Mortality
was defined as death occurring during the hospital stay or within 30 days. Anastomotic
leakage was defined as clinical and asymptomatic leakage. Clinical suspicious of anastomotic
leakage was systematically confirmed by a CT-scan with contrast enema. Asymptomatic
anastomotic leakage was assessed on a CT-scan with contrast enema, systematically
perforemed before stoma reversal for all patients with diverting stoma.
Secondary end-point was surgeons’ satisfaction. Both surgeons (YP, FB) were asked to
fill a specific questionnaire about the use of the stapler (concerning general ergonomia, anvil
opening, anvil removing, shaft insertion, rectal stump perforation, anvil and shaft mating,
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stapler closing, stapling, stapler removing, “donuts” quality and general appreciation), using
an analogic visual scale. Notations were from 0 to 10, increasing with the level of satisfaction.
Cost-analysis
A cost-analysis was performed from a surgical perspective. Thus, only direct surgical
costs were assessed, including surgical staplers, surgical procedures (including emergency
reoperation), invasive radiological procedures (i.e. percutaneous drainage), and hospital stay.
Costs were evaluated using the French health care system price-list (“classification commune
des actes médicaux”, CCAM).
Statistical analysis
Continuous data are presented as median + standard deviation (range) and were
compared with the Mann-Whitney U test. Proportions are presented as number of patients
(percentage of patients) and were compared with either the Pearson χ2 test or the Fisher exact
test, as appropriate. The level of statistical significance was set at p < 0.05 and tests were
always 2-sided. Analysis was performed using Statistical Package for the Social Sciences
(SPSS, version 16.0, Chicago, IL, USA)
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RESULTS
Chex® group
There were 54 patients (21 male, 39%) with a mean age of 58 + 2 (range 20 to 88)
years. ASA score was 1 for 13 patients (24%), 2 for 36 patients (67%), and 3 for 5 patients
(9%). Mean BMI was 25 + 0.7 (range 18 to 41) kg/m2. Main indications for surgery were
sigmoid diverticulosis in 27 patients (50%) and colon cancer in 19 patients (35%), as
detailed in Table 1.
Laparoscopic approach was used in 51 patients (94&). Two patients required
conversion in laparotomy, because of major obesity (n=1) and for intra-operative intestinal
injury (n-1). A temporary ileostomy was performed in 15 patients (28%) because of local
conditions.
Control group
As detailed in Table 1, the control group included 64 patients with no statistical
difference from the Chex group on the matching criteria: Gender (P=0.227), Age (P=0.442),
ASA grade, BMI (P=0.135), surgical approach (P=0.659), and diverting stoma (P=0.594).
Indication for surgery was colon cancer in 24 patients (38%, P=0.795 comparing to Chex
group), colon adenoma in 4 patients (6%, P=0.730), sigmoid diverticulosis in 34 patients
(53%, P=0.735), sigmoid volvulus in 1 patients (2%, P=1), and inflammatory bowel disease
(IBD) in 1 patients (2%, P=0.592).
Postoperative mortality and morbidity
Postoperative outcome for both groups are detailed in Table 2.
There was no postoperative death in both groups.
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The overall morbidity rate showed no significant difference between both groups (n=9,
17% in the Chex group versus n=16, 25% in the control group, P=0.270).
Five patients (9%) experienced clinical and/or asymptomatic anastomotic leakage in the
Chex® group, without significant difference comparing to the control group (n=5, 8%, P=1).
Compared to the control group, reoperation was required in the Chex group in 4
patients (7%) for peritonitis induced by anastomotic leakage (n=3) and peristomial hernia
(n=1) versus 2 patients (3%) because of peritonitis induced by anastomotice leakage (n=1)
and stoma related small bowel obstruction, without significant difference (P=0.410).
Hospital stay showed no significant difference between both groups: 9 ± 5 (range 5 to
25) days in the Chex group versus 11 ± 10 (range 5 to 75) in the control group (P=0.594).
No post-operative anastomotic stricture was observed in both groups with a mean follow-up
of 12 ± 8 (range 1 to 25) months in the Chex group and 28 ± 7 (range 13 to 44) in the Control
group.
Satisfaction score
All 11 studied items obtained a mean score ranged from 8 to 9.5 out of 10, as detailed
in Table 3. General appreciation was scored 8.1 ± 1.8 (range 3 to 9.5). The less appreciated
item was the anvil removing from the device with a mean score of 8.0 ± 1.6 (range 2 to 9.5).
The most appreciated item was the stapler moving, after performing the anastomosis, which
scored 9.5±1.9 (range 8 to 10).
No major device failure was observed during the study.
Cost-analysis
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Mean evaluated toatl cost was 10,563 + 721 (6,071-29,198) € in the Chex group versus
12, 451 ± 1,411 (6,142-79.058) € in the control group, without significant difference
(p=0.151)
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DISCUSSION
The present study showed that stapled anastomosis using the CHEXTM circular device
is safe and convenient without increasing morbidity and mortality compared to other known
usual devices. The rate of postoperative anastomotic leakage was similar between the two
groups.
In the last years, advances in intestinal stapling devices have led to an increased
frequency of stapled bowel anastomoses. Many studies have evaluated the stapled versus
handsewn methods for colorectal anastomosis. The majority concluded to the insufficiency of
evidence to demonstrate any superiority of a method over the other[2, 3, 11]. Therefore,
stapled technique presents a variety of benefits: better blood supply, reduced tissue
manipulation, less oedema, uniformity of sutures, and rapidity. These factors are believed to
facilitate the anastomosis healing without increasing the incidence of postoperative
complications such as anastomotic leak, prolonged ileus or stricture. In spite of this,
anastomotic dehiscence remains a significant complication of colorectal surgery. In a metaanalysis, the authors showed no clinically relevant difference in mortality and anastomotic
leakage rate between the two methods[3]. The only differences concerned patients with
stapled anastomosis which were more likely to experience intraoperative technical mishaps
and postoperative anastomotic strictures. In the present study, the very short follow-up (12+8
(range 1 to 25)) did not allow to evaluate this latter risk. A systematic review of randomized
controlled trials[14], noted that stricture occurred to a significant extent in patients
undergoing colorectal stapled anastomosis, especially in infra-peritoneal location. It has been
hypothesized that there may be an overactive inflammatory response, leading to stricture
formation[15]. However, the majority was easily managed with endoscopic dilatation or
asymptomatic.
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Moreover, technical problems occurred significantly more often following stapled
anastomoses. A technical mishap is generally defined as a misfiring, or a malfunction, rather
than any difficulty in completing the anastomosis. The main expected risk could be, as Mac
Rae et al. reported, significant morbidity in the stapled group after technical mishap3. In the
current study, no major device failure requiring was observed and the morbidity rate was
similar between the two groups.
The use of staplers for anastomosis in colorectal surgery has been questioned by the
French Society of Digestive Surgery (SFCD) in 2000[1]. The authors recommended, as much
as possible, the routine use of handsewn method for cost reasons. Moreover, a systematic
review has shown that both techniques (stapler vs. handsewn) were effective, and the choice
should be based on personal preference[3]. This point highlights the financial aspect of
stapling methods. The question of cost is related to the length of the operative procedure,
length of hospitalization, price of sutures and value of devices used, among other factors. The
Cochrane analysis showed that when only the cost of the material used in the anastomosis
was taken into consideration, the stapler was more expensive[11]. In France, the Chex® CS
stapler is sold 239 euros (exclusive of taxes), whereas the only 2 other circular staplers
available in France, the CDH® stapler (Ethicon Endo-Surgery, Inc; Cincinnati, OH, USA)
and the EEA® stapler (Autosuture, Covidien, MA, USA) are sold 310.07 euros (exclusive of
taxes) and 314.66 euros (exclusive of taxes), respectively.
In the present study, cost analysis did not demonstrate a significant cost reduction
associated with the use of the Chex stapler. The relatively small number of included patients,
as well as the fact that the post-operative course showed no significant difference between the
2 groups might explain this result. However the Chex® stapler is sold in France
approximately 75 € cheaper than the other devices, making an average 7.500 € cost reduction
per year in our department. The cost of an operative procedure, however, must be analyzed
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within a wider context involving not only the monetary value of the materials but also the
value resulting from the ease of execution, total time consumed, cost of complications related
to the method employed, among other factors. Fingerhut et al showed that the time taken to
perform the anastomosis was wignificantly shorter in stapled colorectal anastomosis[2]. This
factor had a relative value when analyzed in isolation, e.e. when not associated with the total
length of the operative procedurs of hospitalization of the patient. An Italian study has
evaluated the cost/benefit ratio of stapled anastomoses in colorectal surgery on the basis of an
8 year experience taking into account the overall costs in surgery as well as short term and
long term benefits. Mechanical suturing was found to be superior based on the average
postoperative hospital stay which decreased from 20 to 14 days [16].
CONCLUSION
In conclusion, this control-case study has suggested that colorectal stapled anastomosis
using the CHEXTM circular device was safe with similar operative results compared to other
known devices. This procedure was also convenient with high surgeons’ satisfactory without
major failure. Further data with longer follow-up is required to assess long term postoperative course.
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REFERENCES
1.
Slim K, Panis Y, Perniceni T, Escat J. [Mechanical sutures in digestive surgery.
Guidelines of the French Society of Digestive Surgery]. J Chir (Paris) 2000; 137: 5-12.
2.
Fingerhut A, Hay JM, Elhadad A, Lacaine F, Flamant Y. Supraperitoneal colorectal
anastomosis: hand-sewn versus circular staples--a controlled clinical trial. French
Associations for Surgical Research. Surgery 1995; 118: 479-85.
3.
MacRae HM, McLeod RS. Handsewn vs. stapled anastomoses in colon and rectal
surgery: a meta-analysis. Dis Colon Rectum 1998; 41: 180-9.
4.
Adloff M, Arnaud JP, Beehary S. Stapled vs sutured colorectal anastomosis. Arch
Surg 1980; 115: 1436-8.
5.
Moreno Gonzalez E, Rico Selas P, Mansilla Molina D, Gomez Sanz R, Ramos
Martinez R, Seoane Gonzalez J, et al. Results of surgery for cancer of the rectum with
sphincter conservation. A randomized study on instrumental versus manual
anastomosis. Acta Oncol 1989; 28: 241-4.
6.
Cajozzo M, Compagno G, DiTora P, Spallitta SI, Bazan P. Advantages and
disadvantages of mechanical vs. manual anastomosis in colorectal surgery. A
prospective study. Acta Chir Scand 1990; 156: 167-9.
7.
Sarker SK, Chaudhry R, Sinha VK. A comparison of stapled vs. handsewn
anastomosis in anterior resection for carcinoma rectum. Indian J Cancer 1994; 31:
133-7.
8.
McGinn FP, Gartell PC, Clifford PC, Brunton FJ. Staples or sutures for low colorectal
anastomoses: a prospective randomized trial. Br J Surg 1985; 72: 603-5.
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9.
Griffen FD, Knight CD, Sr., Whitaker JM, Knight CD, Jr. The double stapling
technique for low anterior resection. Results, modifications, and observations. Ann
Surg 1990; 211: 745-51; discussion 751-2.
10.
Alves A, Panis Y, Mantion G, Slim K, Kwiatkowski F, Vicaut E. The AFC score:
validation of a 4-item predicting score of postoperative mortality after colorectal
resection for cancer or diverticulitis: results of a prospective multicenter study in 1049
patients. Ann Surg 2007; 246: 91-6.
11.
Lustosa SA, Matos D, Atallah AN, Castro AA. Stapled versus handsewn methods for
colorectal anastomosis surgery. Cochrane Database Syst Rev 2001:CD003144.
12.
Noblett SE, Horgan AF. A prospective case-matched comparison of clinical and
financial outcomes of open versus laparoscopic colorectal resection. Surgical
Endoscope 2007; 21: 404-8.
13.
Miettinen OS. Individual matching with multiple controls in the case of all-or-none
responses. Biometrics 1969; 25: 339-55.
14.
Lustosa SA, Matos D, Atallah AN, Castro AA. Stapled versus handsewn methods for
colorectal anastomosis surgery: a systematic review of randomized controlled trials.
Sao Paulo Med J 2002; 120: 132-6.
15.
Dziki AJ, Duncan MD, Harmon JW, Saini N, Malthaner RA, Trad KS, et al.
Advantages of handsewn over stapled bowel anastomosis. Dis Colon Rectum 1991;
34:442-8.
16.
Donini I, Mari C, Buccoliero F, et al. [Mechanical staplers in colorectal surgery: costbenefit ratio]. G Chir 1990; 11:463-5.
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Professor Giuliano Reboa Italy Controlled digital stretching in the prevention of post-defecation anal pain
in patients undergoing Longo’s technique of stapled haemorrhoidectomy
Pilot Study
Giuliano Reboa, Marco Gipponi, Tommaso Testa, Matteo Ligorio
Parole chiave: Emorroidi – Ipertono sfinteriale – Divulsione anale
Key words: Haemorrhoids – High anal canal pressure – Controlled digital
stretching
Dipartimento di Chirurgia
U.O.C. Chirurgia Generale, Malattie Colon-Retto-Ano
Azienda Ospedaliera Universitaria “San Martino”, Genova
Tel: +39-010-5555300; Fax: +39-010-5556664
e-mail: [email protected]
Corrispondence to:
Dott. Marco Gipponi
U.O.C. Chirurgia Generale, Malattie Colon-Retto-Ano
Azienda Ospedaliera Universitaria “San Martino” – Genova
L.go R. Benzi, 8
16132 Genova
e-mail: [email protected]
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Abstract
Background: Six to 7 percent of patients undergoing stapled anopexy are affected by postdefecation anal pain which typically occurs 20-30 minutes after defecation and can last
between 2-12 hours. It is believed that this is created by a variety of technical or technique
problems, postoperative anal fissures or fistula, and in particular preoperative high anal canal
pressures that, it is believed, could be solved by controlled, pre-operative, digital stretching.
On this basis a pilot study was performed in 40 patients with hemorrhoids and associated
high anal pressures who underwent controlled digital stretching before the introduction of the
operative proctoscope and completion of the stapled anopexy procedure. Patients and
Methods: From March to November 2008, 40 patients with stage III-IV haemorrhoids,
associated with high anal resting (> 65 mmHg) and squeezing pressures (> 90 mmHg), had
preoperative colonoscopy and quality of life assessment by means of a standardized
questionnaire (GIQLI, Gastrointestinal Quality of Life Index). The first 20 patients had
stapled anopexy using PPH03-33 TM (Johnson & Johnson) while in the remaining 20 patients
CPH32/34
TM
(Chex™ Surgical Staplers. Frankenman International Limited ) was used.
Early (0-48 hours) and late (3-7 day) postoperative complications were recorded, with
clinical and manometric reassement after two months. Results: After a median follow-up of 8
months (range: 4-12 months), pre- and postoperative quality of life scores were similar in
both groups of patients (PPH03-33TM vs. CPH32/34TM), with a significant overall
postoperative increase of patient’s satisfaction index (P < 0.005). Intraoperative haemostasis
was achieved with a lower number of stitches in CPH32/34TM group (1.3 vs. 2.5,
respectively). Moreover, postoperative anal resting (P < 0.001) and squeezing pressures (P <
0.05) were significantly reduced. Clinically relevant was that post-defecation anal pain was
never observed, and VAS scores of post-defecation anal pain and urgency were rather low
(2.3 and 3, respectively). Conclusions: Controlled digital stretching in patients with III-IV
degree hemorrhoids associated with high anal pressures undergoing stapled anopexy enables
reduction of anal resting and squeezing pressures thus minimizing the risk of post-defecation
anal pain.
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Introduction
Longo’s 1 technique of stapled haemorrhoidectomy is currently the preferred method
for treating haemorrhoids, both on a physiopathological basis and because of the proven
clinical and functional advantages when compared to a conventional haemorrhoidectomy 2-10.
Nevertheless, this procedure also carries the risk of early and late postoperative complications
and, in particular, post-defecation anal pain that can sometimes appear up to 1-3 weeks after
the intervention with onset of pain 20-30 minutes after evacuation and a tendency to persist
for 2-12 hours. This affects about 6-7% of patients, although other clinical studies show that
it occurs across a wider range (0-25%); the causes can be operative failures or physiological
(e.g, inclusion of muscular fibres during the operation, technical errors such as when suturing
for anastomosis is too distal, applying haemostasis sutures too near the dentate line, and the
presence of fissures and anal fistulars) but, in about half of cases, the reason remains
unknown
9-10
. It is worth noting that both clinical and manometry evidence of high
preoperative anal pressure readings is frequent in patients with haemorrhoidal disease 11-13. In
our clinical experience, gathered from over 500 cases of anopexy performed since year 2000,
evidence of post-defecation anal pain is currently mainly anecdotal (<1%) which we would
be ascribed to the systematic performance of controlled digital stretching in patients with
high anal pressure prior to insertion of the operating proctoscope.
In order to confirm this working hypothesis, a pilot study was conducted on 40
patients affected by 3rd and 4th degree haemorrhoids, with high anal pressure reported both
during the physical examination and following anorectal pressure measurements all of whom
underwent controlled digital stretching prior to insertion of the operating proctoscope
proceding anopexy.
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Patients and Methods
From March to November 2008, 40 consecutive patients affected by 3rd and 4th degree
haemorrhoids were recruited; the first 20 patients underwent stapled anopexy using a PPH3303TM (manufactured by Johnson & Johnson) stapler while the remaining 20 patients
underwent stapled anopexy using a Chex™ CPH32/34TM stapler (manufactured by
Frankenman International Limited). In all cases, their anorectal pressure measurements
demonstrated high anal pressure, with basal anal pressures measuring > 65 mmHg and
maximum anal resting pressures measuring > 90 mmHg. Multiparous or fertile patients were
excluded. Informed consent for the intervention was obtained from all patients and the
interventions were all performed by the same surgeon (G.R.) from the U.O.C. di Chirurgia
Generale, Malattie Colon-Retto-Ano della A.O.U. “San Martino” di Genova.
All patients carried out a quality of life assessment by means of a standardized
questionnaire (GIQLI, Gastrointestinal Quality of Life Index)
14
. They also underwent a
preoperative colonoscopy to exclude attendant pathologies as well as
preoperative and
postoperative (two months after the intervention) anorectal manometry to assess any
functional changes caused by the intervention.
At the time of the postoperative anal
manometry, quality of life was reassessed using the GIQLI questionnaire.
During the intervention, the number of sutures required to achieve complete
haemostasis at the suture line was recorded. Post-operative complications were divided into
early (0-48 hours),
taking into account urinary retention, haemorrhage, haemorrhoid
thrombosis, anastomotic dehiscence, and local infections, and late (3-7 days after the
intervention) taking into account, in particular, anorectal pain, fecal urgency, constipation,
and fecal straining, which were assessed using a visual analogue scale (VAS) on a scale from
0 (no symptom) to 10; fecal incontinence was divided into: absent (0), minor (1) and major
(2).
28
Anorectal manometry.- During anorectal manometry, polyethylene tubes containing
open-ended tips (Medtronic) with continuous perfusion of twice-distilled water were used. 6
radial recording points were located on a level with and 5 cm from the top of the anal
sphincter, where a latex balloon was applied to distend the walls of the rectal ampulla. The
tube was connected via a hydraulic system to the signal interpretation unit (PC Poligraf VIII Synectics Medical, USA) that sends data via a fibre-optic cable to a computer which then
displays the graphics of the pressure/time curves in real time on the monitor. The patient is
positioned on a bed lying on their left side at standard height and the tube is introduced
transanally. The parameters recorded during the examination include: length of the anal canal,
basal and maximum anal resting pressure and anal squeeze pressure, length of maximum
voluntary contraction, residual tone, objective anorectal inhibitory reflex,
subjective
anorectal inhibitory reflex, and abdominal pain threshold 15.
Stapled Anopexy.- The intervention has always been performed under spinal anaesthesia and
with the patient placed in a lithotomic position with a Trendelenburg tilt. Controlled digital
stretching is performed initially with two fingers (index fingers) introduced carefully inside
the anus and performing moderate traction laterally (gradually separating the two index
fingers) and in an antero-posterior direction with fingers stretched (taking care not to hook
the muscles of the pelvic floor). Then, the fingers are moved in a circular motion around the
anus to gently break the inner sphincter fibres. Afterwards, two fingers on each hand are
inserted repeating the circular motion to increase anal dilatation, but avoiding 6-8 finger
forced anal dilatation utilising the method described by Lord
16
. Then, the lubricated anal
dilator (CAD) is inserted with an obturator, an integral part of the PPH33-03TM instrument kit
(Ethicon Endo-Surgery, Inc., Pratica di Mare, Roma, Italia) and the Chex™ CPH32/34TM kit
( Frankenman International Limited, Hong Kong). This is then sutured to the perianal skin
with four stitches. Once the obturator is removed, a surgical anoscope is inserted into the
29
lumen of the CAD and a 2-0 Prolene purse-string suture is inserted about 2 cm above the
dentate line. The circular stapler is inserted fully open and the purse-string suture is secured
to the central axis the suture threads are then retrieved through the suture conduitspositioned
on either side of the head and secured in a manner to allow gentle digital pressure on the
sutures to draw mucosa and sub-mucosa into the staple housing. The stapler is then fired in
order to perform the prolapsectomy and rectopexy, having completed all necessary check to
avoid rectovaginal fistula. Once the stapler has been removed, the integrity of the mucosal
cylinder removed (donut) is checked, then a few haemostatic sutures are placed along the
anastomatic line in reabsorbable material (Vicryl 3-0) where required. After prolonged
observation (5-10 minutes) to check that haemostasis is complete, an absorbable plug is
placed in the anal canal. This concludes the intervention.
Results
40 patients underwent stapled anopexy, 29 male and 11 female, aged between 31 and
73 years (with an average age of 53 years). The breakdown by sex was equal for both groups
while age was on average higher in the patients that underwent surgery with the Chex™
CPH32/34TM stapler (59 years: range 31-68 years vs. 47 years: range 32-73 years).
The median follow-up was after about 8 months (range: 4-12 months). The overall
quality of life score using the standardized GIQLI questionnaire was equal for both groups in
the preoperative and postoperative phase, and both groups showed significant improvement
(P < 0,005) on the postoperative patient satisfaction index.
The results of the anorectal manometry showed that both groups of patients constantly
recorded higher than normal average preoperative basal and maximum anal resting pressures
but with a significant reduction (P < 0,001) in the postoperative phase. Objective and
subjective rectoanal inhibitory reflexes recorded only slightly higher than normal average
30
preoprative values with substantial normalization at the postoperative check-up. Finally, the
abdominal pain threshold fell within the normal range both in preoperative and postoperative
phases (Table 1).
Haemostasis during the intervention was performed with an average number of sutures equal
to 1.3 + 0.3 (ES) in the group using the CPH32/34TM stapler and 2.5 + 0.8 (ES) in the group
using the PPH33-03TM stapler. The frequency and type of early complications included one
haemorrhage in both groups, which were resolved with conservative measures, and one case
of urinary retention in the PPH33-03TM group. Late complications such as anorectal pain and
fecal urgency scored less on average for the CPH32/34TM group, although this was of no
significance statistically, and no patient complained of postoperative defecation disorders
such as post-defecation pain and/or discomfort; the other parameters were more or less equal
for both groups (Table 2).
Discussion
The prevalence of haemorrhoidal disease in the adult population shows a variability
factor of between 4% and 34% 17. Pathogenesis of the disease varies according to a series of
changes associated with the subepithelial vascular plexus of the anal canal; this type of
vascular pad plays an important role in the mechanism of continence, in sinergy with the
muscular activity of the anal sphincter which allows the anus to fully close
18-19
. Congestion
and hypertrophy of these anal pads typically leads to bleeding (especially at the end of
defecation or during post-defecation cleaning), itching and/or anal soiling, and sometimes
anal pain/discomfort
19-20
. Pathogenetic hypotheses put forward are the increase in
endoabdominal pressure, portal hypertension (secondary haemorrhoids), constipation and
fecal straining, changes in the connective support tissue, as well as tissue metaplasy 20. More
31
recently, onset of haemorrhoids has been linked to rectal prolapse (mucosal or full-thickness);
according to Longo, for internal haemorrhoids to prolapse, the tissue above them must
prolapse, too, which means the rectal tissue 21.
To treat this condition, many so-called clinical solutions are available for 2nd degree
haemorrhoids according to the severity of the clinical presentation (e.g., cryotherapy,
sclerotherapy) while more radical surgical solutions are preferred for 3rd and 4th degree
haemorrhoids, such as conventional haemorrhoidectomy (Milligan-Morgan). For some years
now, stapled anopexy has come to the fore, which, compared to conventional surgery, offers
less side effects (urinary retention, postoperative defecation disorders, fecal mass, and, above
all, postoperative pain), although it does report a greater risk of relapse (OR = 3.85; IC 1.4710.07) because, amongst other reasons, for the specific features of the intervention, which, as
is well known, does not include the surgical removal of the haemorrhoids but the mucosal
prolapse above them
2-10
.
Certainly, in terms of postoperative morbidity, given that it is a specialist intervention,
there are a series of so-called “surgeon-dependent” problems to consider, linked to the
specific experience in stapler-assisted transanal surgery. With regard to this, a learning curve
for the technical-surgical acquisition of stapled anopexy techniques has been recorded,
which should include sufficient surgical training, including at least 30-50 interventions
10
.
This would reduce the risk of complications, at times quite serious, recorded anecdotally for
this type of intervention.
We believe that a particularly significant post-operative clinical problem for this type of
intervention is the onset of post-defecation pain 1-3 weeks after the intervention with anal
pain/discomfort, which typically comes on 20-30 minutes after defecation and can persist for
as long as 2-12 hours. These problems affect about 6-7% of patients, although case studies
32
report a greater range (0-25%); the causes can be organic (e.g, inclusion of muscular fibres
during the operation, technical errors such as when suturing for anastomosis is too distal,
applying haemostasis sutures near the dentate line, presence of fissures and anal fistules) but,
in about half of cases, the reason remains unknown 9-10.
It is worth noting that both clinical and manometry evidence of high preoperative anal
pressure readings is frequent in patients with haemorrhoidal disease 11-13. In fact, historically,
it has been recorded that patients with haemorrrhoidal disease presenting with anal
pain/discomfort and proctorrhage, especially in male patients, basal and maximum anal
resting pressures as well as anal squeeze pressures are higher than for aysmptomatic patients
of the same age and sex
11-13
. The causes of high anal pressure have from time to time been
attributed to a high percentage of type 1 muscle fibres in the external anal sphincter (from
biopsies taken during haemorrhoidectomy), suggesting tonic contraction of the muscle; or to
hyperactivity of the internal anal sphincter, as shown by the activity of ultraslow waves, as
well as the tension of the anal pads 22-24. Looking at the profile of this form of treatment, the
most significant aspect is the reduction in basal anal pressure after controlled digital
stretching, which is consistently achieved even during follow-ups after 5-6 years, with a
corresponding elimination of ultraslow wave activity and a clear improvement in painful
symptoms 25-26.
The data obtained from this experience indicate that, thanks to the performance of
controlled digital stretching, a significant reduction was effectively recorded in the basal,
maximum anal resting pressures and anal squeeze pressure together with post-operative VAS
scores being quite low both for anorectal pain and for fecal urgency, registering 2.3 and 3
respectively; above all, none of the patients complained of defecation problems with a
sensation of post-defecation pain and/or discomfort. Moreover, the specific methods
described for the performance of controlled digital stretching, but avoiding the 6-8 finger
33
forced anal dilatation method described before have,we believe, prevented cases of iatrogenic
incontinence. These results were obtained regardless of the type of stapler used and, given
that the interrvention was performed by the same surgeon, the surgeon-dependent variable
was most certainly reduced to a minimum.
In our opinion, stapled anopexy is the modern answer to the resolution of rectal
prolapse which underpins the onset of haemorrhoidal disease. This intervention, however, is
not specifically designed for the resolution of associated high anal pressure, which can be
effectively treated using controlled digital stretching, and thus preventing anal pain and
postoperative defecation problems linked to persistent high anal pressure.
Finally, in terms of the difference in the results recorded by the type of stapler used,
the Chex ™CPH32/34TM model required less sutures to obtain complete haemostasis of the
anastomatic line. Moreover, thanks to the specific equipment included in the kit, this
instrument allows a level of adaptability that goes far beyond the operating conditions, both
thanks to the double “butterfly” shape of the proctoscope, which is better suited to the
anatomy of the male, and because it offers a choice of two sizes (32mm and 34mm), thus
allowing adjustment for the size of the prolapsectomy.
Conclusions
The data obtained allows us to affirm that controlled digital stretching, carried out on
patients affected with 3rd and 4th degree haemorrhoids with high anal pressure and undergoing
stapled anopexy, consistently reduces the basal and maximum anal resting pressures and anal
squeeze pressure. This means that post-defecation pain can be avoided regardless of the type
34
of stapler used or the surgeon-dependent variable, even considering the limits imposed by a
pilot study in terms of sample numbers and without a control group.
For this reason, an additional clinical trial will be conducted on patients put forward
for anopexy for mucosal and haemorrhoidal prolapse associated with high anal pressure, who
will be randomly treated with controlled digital stretching, always by the same surgeon, in
order to confirm the efficacy of this procedure for the prevention of post-defecation anal pain.
The data relating to the type of stapler used allows us to claim better haemostatic
control of the anastomatic line as well as better adaptability, both to the particular anatomical
shape of the of the patient as well as the size of the prolapse, for the Chex™ CPH32/34.
35
Table 1: Overall clinical characteristics of the 40 patients taking part in the study.
___________________________________________________________________________
Sex (M/F)
29/11
Age, years (range)
53 (31-73)
Quality of Life (G.I.Q.L.I.: range = 0–144)
Pre
52 (6)
Post
31 (4)
P*
< 0,005
Manometry Parameters
Pre
Post
P*
Basal anal pressure (v.n. 65-45 mmHg)
90 (7)
52 (4)
< 0,001
Squeeze pressure (v.n. > 90 mmHg)
151 (9)
129 (6)
< 0,05
Objective rectoanal inhibitory reflex (v.n. 20-40 cc)
44 (4)
34 (5)
ns
Subjective rectoanal inhibitory reflex (65-45 cc)
89 (10)
63 (9)
ns
Abdominal pain threshold (v.n. 180-250 cc)
231 (27)
196 (19)
ns
The GIQLI score and the values of the manometry parameters are expressed as an average
with the standard error of the average value (in brackets). Pre = pre-operative; Post = postoperative; ns = not significant; P*: Wilcoxon’s signed rank-sum test.
Table 2: Post-operative complications by group (PPH33-03TM, CPH32/34TM) and the
total of the 40 patients studied.
___________________________________________________________________________
PPH33-03
CPH32/34)
Total
(n = 20)
(n = 20)
(n = 40)
Postop Complications (0 – 48 hours)
Urinary Retention
1
0
1 (2,5%)
Haemorrhage
1
1
2 (5%)
Haemorrhoid Thrombosis
0
0
0
Anastomotic Dehiscence
0
0
0
Infection
0
0
0
Postop Complications (3 – 7 days)
Anorectal Pain *
2,7 (0,8)
1,8 (0,7)
2,3 (0,9)
Rectal Urgency *
4,0 (1,1) 2,0 (1,2)
3,0 (1,3)
Constipation
2,6 (1,3) 2,0 (1,1)
2,3 (1,4)
Straining *
4,8 (1,2)
5,6 (1,5)
5,2 (1,7)
Fecal Incontinence #
0
0
0
* VAS Score (range: 0-10); the values are expressed as an average (standard error of the
average).
# Incontinence Score: 0 = absent; 1 = minor; 2 = major
36
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Professor Kupcsulik, Péter K. Hungary 40
APPENDIX B. Dundee University. Dr. Stuart Brown. Synopsis of Technical Assessment of Chex Surgical Stapler in Comparison to Ethicon (the current market leader 41
42