Universal Surgical approach to the Gynecologic Patient

PATIENT SAFETY & SURGERY: BEFORE, DURING AND AFTER
Scott Graziano MD, MS
Associate Professor
Loyola University Chicago
Stritch School of Medicine
Disclosures •  Nothing to Disclose Objec3ves •  Understand the ra3onale and types of pa3ent safety measures •  Understand the pre-­‐opera3ve prepara3on BEFORE entering the opera3ng room •  Understand the measures taken to keep pa3ents safe IN the opera3ng room •  Understand the measures needed to safely conclude the procedure 1
•  What do YOU think is important for pa3ent safety in the opera3ng room? SCIP: Surgical Care Improvement Project •  A na3onal quality partnership of organiza3ons interested in improving surgical care by significantly reducing surgical complica3ons. •  SCIP Partners include the Steering CommiOee of 10 na3onal organiza3ons who have pledged their commitment and full support for SCIP. SCIP: Surgical Care Improvement Project •  Agency for Healthcare Research and Quality •  American College of Surgeons •  American Society of Anesthesiologists •  Associa3on of Periopera3ve Registered Nurses •  CDC •  The Joint Commission •  VA 2
Surgical Care Improvement Project • 
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Timing of an3bio3c administra3on Correct an3bio3c administra3on An3bio3c discon3nued Appropriate hair removal Glucose control day of surgery Periopera3ve temperature management Periopera3ve beta blocker administra3on Removal of Foley catheter VTE prophylaxis ordered VTE prophylaxis administered ACS NSQIP •  American College of Surgeons •  Na3onal Surgical Quality Improvement Program –  Quality improvement data –  Self repor3ng –  Na3onal database –  Benchmarked –  Risk adjusted The Joint Commission •  Universal Protocol –  Wrong person, wrong site, wrong procedures CAN be prevented –  The pa3ent and family should be as involved as possible 3
The Joint Commission •  Pre-­‐procedure verifica3on –  Relevant documenta3on (H&P) –  Labeled diagnos3cs and imaging –  Required blood, devices, materials, special equipment •  Mark the procedure site –  Body diagram The Joint Commission •  Perform a 3meout –  Final assessment of pa3ent, site and procedure –  Involves all OR staff and physicians The Night Before Surgery…
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REFLECTION! Reflect: The Night Before • 
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What procedure you are doing? Why? Relevant anatomy Instruments needed Steps to the procedure Common complica3ons –  What problems might you encounter? Reflect: The Night Before •  Know your patient
–  BMI
•  Change your instruments?
•  Post procedure imaging?
–  Medical comorbidities
–  Prior surgeries
•  Affect route/access?
•  Alternative equipment?
–  Religious/cultural concerns
•  Jehovah’s Witness
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The Day Of Surgery • 
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Informed consent An3bio3c prophylaxis DVT prophylaxis OR e3queOe Pa3ent posi3oning Prepping and draping Informed Consent •  A wriOen or verbal agreement by the subject of a test or the subject's legally authorized representa3ve without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion, which entails at least the following pre-­‐test informa3on: •  Illinois General Assembly, Compiled Statutes, PA 98-­‐214 effec3ve 8/9/13 Informed Consent •  A fair explana3on of the test, including its purpose, poten3al uses, limita3ons and the meaning of its results; and •  A fair explana3on of the procedures to be followed, including the voluntary nature of the test, the right to withdraw consent to the tes3ng process at any 3me, the right to anonymity to the extent provided by law with respect to par3cipa3on in the test and disclosure of test results, and the right to confiden3al treatment of informa3on iden3fying the subject of the test and the results of the test, to the extent provided by law. •  Illinois General Assembly, Compiled Statutes, PA 98-­‐214 effec3ve 8/9/13 6
Informed Consent • 
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Risks Benefits Indica3ons Alterna3ves The Day Of Surgery • 
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Informed consent An3bio3c prophylaxis DVT prophylaxis OR e3queOe Pa3ent posi3oning Prepping and draping An3bio3c Prophylaxis •  Preven3on of surgical site infec3ons –  5% of pa3ents develop –  Longer hospitaliza3ons –  More cost –  May affect reimbursement •  Too much of a good thing? –  An3bio3c resistance •  Jarvis WR. Infect Control Hosp Epidemiol. 1996 7
An3bio3c Prophylaxis •  When do you give it? –  Within 60 minutes prior to incision •  When do you need more? –  > 2 3mes the half life of the drug •  Cefazolin: about 4 hours –  > 1500 mL blood loss reactions and side effects. Cefazolin (1 g) is the most
commonly used agent because of its reasonably long
half-life (1.8 hours) and low cost. Most clinical studies
indicate that it is equivalent to other cephalosporins that
have improved in vitro activity against anaerobic bacteria in clean-contaminated procedures such as a hysterectomy. Table 1 lists antibiotic regimens by procedure.
The dose of the prophylactic antibiotic in morbidly
obese patients should be increased. Morbidly obese
patients can be defined in this context as having a body
mass index greater than 35 or weight greater than 100 kg
(220 pounds). One study showed lower blood levels and
tissue levels of cefazolin in morbidly obese patients
when compared with control patients (body mass index
22 plus or minus 4). The standard single cefazolin dose
of 1 g should be doubled to 2 g (10).
Adverse Reactions to Antibiotics
Adverse effects include allergic reactions ranging in
severity from minor skin rashes to anaphylaxis. Anaphylaxis, the most immediate and most life-threatening
risk of prophylaxis, is rare. Anaphylactic reactions to
penicillin reportedly occur in 0.2% of courses of treatment, with a fatality rate of 0.0001% (11).
Pseudomembranous colitis is an uncommon complication of antibiotic prophylaxis even though cephalosporins cause an increase in gastrointestinal colonization
with Clostridium difficile (12). However, overall antibi-
An3bio3c Prophylaxis Table 1. Antimicrobial Prophylactic Regimens by Procedure*
Procedure
Antibiotic
Dose (single dose)
Hysterectomy
Urogynecology procedures,
including those involving mesh
Cefazolin†
1 g or 2g‡ IV
Clindamycin§ plus
gentamicin or
quinolonell or
aztreonam
600 mg IV
1.5 mg/kg IV
400 mg IV
1 g IV
Metronidazole§ plus
gentamicin or
quinolonell
500 mg IV
1.5 mg/kg IV
400 mg IV
Laparoscopy
Diagnostic
Operative
Tubal sterilization
None
Laparotomy
None
Hysteroscopy
Diagnostic
Operative
Endometrial ablation
Essure
None
Doxycycline¶
Hysterosalpingogram or
Chromotubation
IUD insertion
None
Endometrial biopsy
None
Induced abortion/dilation
and evacuation
Doxycycline
Metronidazole
Urodynamics
None
100 mg orally, twice daily
for 5 days
100 mg orally 1 hour before
procedure and 200 mg orally
after procedure
500 mg orally twice daily for 5 days
Abbreviations: IV, intravenously; IUD, intrauterine device
*A convenient time to administer antibiotic prophylaxis is just before induction of anesthesia.
†
Acceptable alternatives include cefotetan, cefoxitin, cefuroxime, or ampicillin-sulbactam.
‡
A 2-g dose is recommended in women with a body mass index greater than 35 or weight greater than 100 kg or 220 lb.
§
Antimicrobial agents of choice in women with a history of immediate hypersensitivity to penicillin
ll
Ciprofloxacin or levofloxacin or moxifloxacin
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If patient has a history of pelvic inflammatory disease or procedure demonstrates dilated fallopian tubes. No prophylaxis is
indicated for a study without dilated tubes.
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ACOG Practice Bulletin No. 104
reactions and side effects. Cefazolin (1 g) is the most
commonly used agent because of its reasonably long
half-life (1.8 hours) and low cost. Most clinical studies
indicate that it is equivalent to other cephalosporins that
have improved in vitro activity against anaerobic bacteria in clean-contaminated procedures such as a hysterectomy. Table 1 lists antibiotic regimens by procedure.
The dose of the prophylactic antibiotic in morbidly
obese patients should be increased. Morbidly obese
patients can be defined in this context as having a body
mass index greater than 35 or weight greater than 100 kg
(220 pounds). One study showed lower blood levels and
tissue levels of cefazolin in morbidly obese patients
when compared with control patients (body mass index
22 plus or minus 4). The standard single cefazolin dose
of 1 g should be doubled to 2 g (10).
Adverse Reactions to Antibiotics
Adverse effects include allergic reactions ranging in
severity from minor skin rashes to anaphylaxis. Anaphylaxis, the most immediate and most life-threatening
risk of prophylaxis, is rare. Anaphylactic reactions to
penicillin reportedly occur in 0.2% of courses of treatment, with a fatality rate of 0.0001% (11).
Pseudomembranous colitis is an uncommon complication of antibiotic prophylaxis even though cephalosporins cause an increase in gastrointestinal colonization
with Clostridium difficile (12). However, overall antibi-
An3bio3c Prophylaxis Table 1. Antimicrobial Prophylactic Regimens by Procedure*
Procedure
Antibiotic
Dose (single dose)
Hysterectomy
Urogynecology procedures,
including those involving mesh
Cefazolin†
1 g or 2g‡ IV
Clindamycin§ plus
gentamicin or
quinolonell or
aztreonam
600 mg IV
1.5 mg/kg IV
400 mg IV
1 g IV
Metronidazole§ plus
gentamicin or
quinolonell
500 mg IV
1.5 mg/kg IV
400 mg IV
Laparoscopy
Diagnostic
Operative
Tubal sterilization
None
Laparotomy
None
Hysteroscopy
Diagnostic
Operative
Endometrial ablation
Essure
None
Hysterosalpingogram or
Chromotubation
Doxycycline¶
IUD insertion
None
Endometrial biopsy
None
Induced abortion/dilation
and evacuation
Metronidazole
Urodynamics
None
Doxycycline
100 mg orally, twice daily
for 5 days
100 mg orally 1 hour before
procedure and 200 mg orally
after procedure
500 mg orally twice daily for 5 days
Abbreviations: IV, intravenously; IUD, intrauterine device
*A convenient time to administer antibiotic prophylaxis is just before induction of anesthesia.
†
Acceptable alternatives include cefotetan, cefoxitin, cefuroxime, or ampicillin-sulbactam.
‡
A 2-g dose is recommended in women with a body mass index greater than 35 or weight greater than 100 kg or 220 lb.
§
Antimicrobial agents of choice in women with a history of immediate hypersensitivity to penicillin
ll
Ciprofloxacin or levofloxacin or moxifloxacin
¶
If patient has a history of pelvic inflammatory disease or procedure demonstrates dilated fallopian tubes. No prophylaxis is
indicated for a study without dilated tubes.
ACOG Practice Bulletin No. 104
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An3bio3c Prophylaxis •  Cesarean sec3ons –  Cefazolin 2g –  Penicillin allergy? •  Clindamycin •  Gentamicin –  Timing? •  No different •  Not at cord clamping The Day Of Surgery • 
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Informed consent An3bio3c prophylaxis DVT prophylaxis OR e3queOe Pa3ent posi3oning Prepping and draping DVT Prophylaxis •  Almost 8 million surgical patients
annually in US
–  24% high risk, 17% very high risk
•  150,000 deaths attributed
•  Risk Factors
–  Increasing age
–  Cancer
–  Obesity
–  Prior VTE
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LUHS Guideline for Prevention of VTE
DVT Prophylaxis Adult LUHS Guideline for the Prevention of VTE (Venous Thromboembolism) in Inpatient Adults
(follow department recommendations for OB patients and specific order sets for Ortho patients)
This evidence based guideline is designed to assist clinicians by providing an analytical framework for the evaluation and
treatment of patients and is not intended to replace a clinician’s judgment.
I. Age
Less than 40 yrs old
Greater than 40 yrs old
0 points
1 point
II. Surgery
Minor-OR time less than 60 min., hospital stay less than 23 hrs 0 points
Major- OR time greater than 60 minutes
1 point
III. Risk Factors: One or more of the following = 1 point
*Previous DVT or PE
*Obesity (BMI > 29)
*Smoking
*Acute medical illness
*Acute or Chronic Lung disease
*Heart or respiratory failure
*CHF
*Central venous catheterization
*Immobility or impaired mobility
*Surgery for Fractures
*Sickle Cell Disease
*Malignancy, including
Myeloproliferative disorders
*Cancer Therapy-hormonal,
chemotherapy, angiogenesis
inhibitors, radiotherapy
*Trauma (major or lower extremity)
*Hip or knee arthroplasty, acute
post-op
*Taking estrogen containing oral
contraceptives or hormone
replacement therapy (e.g.tamoxifen)
*Dehydration
Risk Category
*Inflammatory bowel disease
*Varicose Veins
*Paroxysmal nocturnal hemoglobinuria
*Nephrotic syndrome
*Known inherited or acquired
thrombophilia
*Receiving selective estrogen receptor
modulators
*Active rheumatic disease
*Erythropoiesis stimulating agents
*Pregnancy or post-partum period with
immobility
Medical Prophylaxis Treatment Options
(choose only one medication)
Low Risk = 0 points
Early and aggressive ambulation
High Risk = 1 or more points
Order pharmacological prophylaxis. Order PCDs
if pharmacological contraindication exists
Consider both pharmacological and mechanical
prophylaxis for patients with multiple risk factors
Early and Aggressive Ambulation
* Low dose unfractionated heparin-5000units SQ
every 8 or 12hrs
OR
* Enoxaparin-40mg SQ daily
OR
*Specialty Areas- Trauma/Spinal Cord Injury/Bariatric Patients:
Enoxaparin 30mg SQ every 12 hours
Pharmacologic prophylaxis should not be used in patients with active bleeding or allergy/adverse reaction to
anticoagulant
Pharmacologic prophylaxis should be initiated within 24 hours of surgery or when risk of bleeding is no longer
deemed to contraindicate use of pharmacologic prophylaxis
Pharmacologic prophylaxis should be continued for at least 7 days, until hospital discharge or until patient is
ambulatory or in selected cases for an extended period as deemed appropriate
Daily progress note should address VTE prophylaxis and include rationale if pharmacologic prophylaxis is not
used
Patients with renal impairment: consider heparin or adjusted enoxaparin 30mg SQ daily for CRCL<30mL/min
May also Consult Micromedex or http://www.uptodate.com for dosing guidelines
See Addendum for Pharmacological Prophylaxis Exclusion list
Reference: Geerts, WH et al. Prevention of venous thromboembolism: The Eighth ACCP Conference on Antithrombotic and Thrombolytic
Therapy. Chest. 2008:133:381S-453S.
Implemented September 2006
Revised July 2007, June 2010, July 2011
LUHS Guideline for Prevention of VTE
DVT Prophylaxis Adult LUHS Guideline for the Prevention of VTE (Venous Thromboembolism) in Inpatient Adults
(follow department recommendations for OB patients and specific order sets for Ortho patients)
This evidence based guideline is designed to assist clinicians by providing an analytical framework for the evaluation and
treatment of patients and is not intended to replace a clinician’s judgment.
I. Age
Less than 40 yrs old
Greater than 40 yrs old
0 points
1 point
II. Surgery
Minor-OR time less than 60 min., hospital stay less than 23 hrs 0 points
Major- OR time greater than 60 minutes
1 point
III. Risk Factors: One or more of the following = 1 point
*Previous DVT or PE
*Obesity (BMI > 29)
*Smoking
*Acute medical illness
*Acute or Chronic Lung disease
*Heart or respiratory failure
*CHF
*Central venous catheterization
*Immobility or impaired mobility
*Surgery for Fractures
*Sickle Cell Disease
*Malignancy, including
Myeloproliferative disorders
*Cancer Therapy-hormonal,
chemotherapy, angiogenesis
inhibitors, radiotherapy
*Trauma (major or lower extremity)
*Hip or knee arthroplasty, acute
post-op
*Taking estrogen containing oral
contraceptives or hormone
replacement therapy (e.g.tamoxifen)
*Dehydration
Risk Category
*Inflammatory bowel disease
*Varicose Veins
*Paroxysmal nocturnal hemoglobinuria
*Nephrotic syndrome
*Known inherited or acquired
thrombophilia
*Receiving selective estrogen receptor
modulators
*Active rheumatic disease
*Erythropoiesis stimulating agents
*Pregnancy or post-partum period with
immobility
Medical Prophylaxis Treatment Options
(choose only one medication)
Low Risk = 0 points
Early and aggressive ambulation
High Risk = 1 or more points
Order pharmacological prophylaxis. Order PCDs
if pharmacological contraindication exists
Consider both pharmacological and mechanical
prophylaxis for patients with multiple risk factors
Early and Aggressive Ambulation
* Low dose unfractionated heparin-5000units SQ
every 8 or 12hrs
OR
* Enoxaparin-40mg SQ daily
OR
*Specialty Areas- Trauma/Spinal Cord Injury/Bariatric Patients:
Enoxaparin 30mg SQ every 12 hours
Pharmacologic prophylaxis should not be used in patients with active bleeding or allergy/adverse reaction to
anticoagulant
Pharmacologic prophylaxis should be initiated within 24 hours of surgery or when risk of bleeding is no longer
deemed to contraindicate use of pharmacologic prophylaxis
Pharmacologic prophylaxis should be continued for at least 7 days, until hospital discharge or until patient is
ambulatory or in selected cases for an extended period as deemed appropriate
Daily
progressfor
note
should address
VTE
and include
rationale if pharmacologic prophylaxis is not
LUHS
Guideline
Prevention
of VTE
in prophylaxis
patients undergoing
C/S
used from main LUHS Guideline
Separate
Patients with renal impairment: consider heparin or adjusted enoxaparin 30mg SQ daily for CRCL<30mL/min
May also Consult Micromedex or http://www.uptodate.com for dosing guidelines
LUHS Guideline for the Prevention of VTE (Venous Thromboembolism) in Patients who
Undergo
Cesarean
Section
See Addendum for Pharmacological Prophylaxis
Exclusion
list
DVT Prophylaxis OB This evidence based guideline is designed to assist clinicians by providing an analytical framework for the
evaluation and treatment of patients and is not intended to replace a clinician’s judgment.
Reference: Geerts, WH et al. Prevention of venous thromboembolism: The Eighth ACCP Conference on Antithrombotic and Thrombolytic
Therapy. Chest. 2008:133:381S-453S.
Implemented September 2006
Revised July 2007, June 2010, July 2011
Risk Assessment for Thromboembolism in Patients Who Undergo Cesarean Section
Low Risk-early ambulation
• Cesarean delivery for uncomplicated pregnancy with no other risk factors
Moderate Risk- low-molecular-weight heparin or compression stockings
• Age above 35 yr
• Obesity (BMI above 30)*
• Parity greater than 3
• Gross varicose veins
• Current infection
• Preeclampsia
• Immobility for more than 4 days before
operation
• Major current illness
High Risk- low-molecular-weight heparin and compression stockings
• Presence of more than two risk factors from the
moderate risk section
• Cesarean hysterectomy
• Previous deep-vein thrombosis or known thrombophilia
* BMI denotes body-mass index (the weight in kilograms
divided by the square of the height in meters)
Reference: N Engl J Med 2008; 359:2025-33
Pharmacologic prophylaxis should not be used in patients with active bleeding or allergy/adverse reaction to
anticoagulant
Pharmaocologic prophylaxis should be initiated within 24 hours of surgery or when risk of bleeding is no
longer deemed to contraindicate use of pharmacologic prophylaxis
Doses of Enoxaparin should be significantly reduced in patients with severe renal impairment. Consult
Micromedex or http://www.uptodate.com for dosing guidelines
Pharmacologic prophylaxis should be continued for at least 7 days, until hospital discharge or until patient is
ambulatory or in selected cases for an extended period as deemed appropriate
Daily progress note should address VTE prophylaxis and include rationale if pharmacologic prophylaxis is not
used
10
August 2011
The Day Of Surgery • 
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Informed consent An3bio3c prophylaxis DVT prophylaxis OR e3queOe Pa3ent posi3oning Prepping and draping OR E3queOe •  Introduce yourself –  Before the 3meout! •  Pull what you need –  Gown, gloves •  Make sure you have what you need –  Equipment –  Suture –  Materials The Day Of Surgery • 
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Informed consent An3bio3c prophylaxis DVT prophylaxis OR e3queOe Pa3ent posi3oning Prepping and draping 11
Pa3ent Posi3oning •  Supine •  Dorsal lithotomy –  S3rrups –  Access to perineum •  Vaginal procedures •  Post procedure cystoscopy •  May be aOending preference –  Need to have equipment ready The Day of Surgery • 
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Informed consent An3bio3c prophylaxis DVT prophylaxis OR e3queOe Pa3ent posi3oning Prepping and draping Prepping and Draping •  Can be an ac3ve par3cipant –  Not just the nurses job •  Betadine scrubs and paint •  Duraprep vs Chloraprep –  Iodine versus chlorhexidine •  Know your OR procedure!!!! •  Drapes for procedure –  Supine versus dorsal lithotomy 12
Post Procedure •  Post opera3ve pain control •  Post procedure imaging •  Post procedure cystoscopy Post Opera3ve Pain Control —  Route of administra3on —  IV versus oral —  Watch acetaminophen dose —  Pa3ent controlled analgesia (PCA) —  What medicine, sepngs? —  Epidural —  Beware too many narco3cs —  NSAIDs ok? —  Toradol —  Transversus abdominis plane block (TAP) —  Laparoscopy Post Procedure Imaging •  Retained foreign body –  Incidence varies (1 in 700 at Level I trauma center) –  Sponge (69%), instrument (31%) •  Risk factors –  Emergency surgery –  Unplanned change in surgery (complica3on) –  Elevated BMI –  Absence of count –  Mul3ple surgical teams –  Excessive blood loss -­‐ Teixeira Am Surg 2007 -­‐ Gawande NEJM 2003 13
Post procedure cystoscopy •  1 in 20 pa3ents have lower urinary tract injury with gynecologic surgery •  Delay in recogni3on may lead to long term morbidity •  Majority (95%) can be detected with intraopera3ve cystoscopy -­‐ Ibeanu Obstet Gynecol 2009 Objec3ves Follow Up •  Understand the ra3onale and types of pa3ent safety measures •  Understand the pre-­‐opera3ve prepara3on BEFORE entering the opera3ng room •  Understand the measures taken to keep pa3ents safe IN the opera3ng room •  Understand the measures needed to safely conclude the procedure GOOD LUCK! 14