Author's Accepted Manuscript Risk factors for 30-day perioperative complications after Le Fort colpocleisis Tatiana Catanzarite, Aksharananda Rambachan, Margaret G. Mueller, Matthew A. Pilecki, John Y.S. Kim, Kimberly Kenton
PII: DOI: Reference:
S0022-5347(14)02973-5 10.1016/j.juro.2014.03.040 JURO 11327
To appear in: The Journal of Urology Accepted Date: 10 March 2014 Please cite this article as: Catanzarite T, Rambachan A, Mueller MG, Pilecki MA, Kim JYS, Kenton K, Risk factors for 30-day perioperative complications after Le Fort colpocleisis, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.03.040. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
ACCEPTED MANUSCRIPT
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Catanzarite 1
SC
Risk factors for 30-day perioperative complications after Le Fort colpocleisis
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Tatiana Catanzarite, M.D. a, Aksharananda Rambachan, B.A.b, Margaret G. Mueller, M.D. c, Matthew A. Pilecki, B.A. b, John Y.S. Kim, M.D. b, Kimberly Kenton, M.D., M.S.c a
b
c
Department of Obstetrics and Gynecology, Department of Surgery, and Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois
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Descriptive runninghead (max 50 characters): Colpocleisis has low complication/mortality rates.
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MESH terms: uterine prolapse/pathology, uterine prolapse/surgery, gynecologic surgical procedures/adverse effects, postoperative complications/etiology, retrospective studies
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Abbreviations and acronyms: UTI = urinary tract infection COPD = chronic obstructive pulmonary disease CHF = congestive heart failure PCI = percutaneous coronary intervention TIA = transient ischemic attack DVT = deep venous thrombosis PE = pulmonary embolism VTE = venous thromboembolism SSI = surgical site infection OR = operating room ASA = American Society of Anesthesiologists ACS-NSQIP = American College of Surgeons National Surgical Quality Improvement Program
ACCEPTED MANUSCRIPT Catanzarite 2 Abstract Purpose. To identify rates of and risk factors for complications after colpocleisis using the National Surgical Quality Improvement Program (ACS-NSQIP)
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database.
Materials and Methods. Women undergoing Le Fort colpocleisis from 2005 to 2011 were identified in the NSQIP database. Primary outcomes were 30-day
SC
complication rates. Secondary outcomes were risk factors for complications and impact of age and concomitant sling on morbidity. Clinical and procedural
M AN U
characteristics were compared using χ2 and one-way ANOVA tests. Results. Two hundred eighty-three women were identified. Twenty-three women (8.1%) experienced complications. The most common complication was UTI (18/283, 6.4%). There was one death, for a mortality rate of 0.4%. Increased
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complications were associated with age < 75 years (p=0.03), COPD (p=0.03), hemiplegia (p=0.03), disseminated cancer (p=0.03), and open wound infection (p=0.02). Six patients (2.1%) required return to the operating room within 30
EP
days. Complication rates did not differ based on operative time (p=0.78), inpatient status (p=0.24), resident involvement (p=0.35), concomitant sling
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placement (p=0.81), or type of anesthesia (p=0.27). Women undergoing colpocleisis without (n=191) and with (n=92) sling had similar baseline characteristics. Colpocleisis without and with sling had similar rates of complications (7.9% versus 8.7%, p=0.81), UTI (5.8% versus 7.6%, p=0.55), return to the OR (2.1% versus 2.2%, p=0.97), and mortality (0% versus 1.1%, p=0.15).
ACCEPTED MANUSCRIPT Catanzarite 3
Conclusions. Mortality and complication rates after colpocleisis are low, with UTI
placement does not increase 30-day complication rates.
Introduction
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being the most common postoperative complication. Concomitant sling
SC
Given the aging United States population, steep increases in pelvic floor dysfunction and need for surgical management in elderly patients are
M AN U
anticipatedi,ii; by the year 2050, the demand for treatment of pelvic floor disorders may increase by up to 45%iii. Elderly patients, owing to underlying medical conditions and lower baseline functional status, may experience perioperative
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morbidity and mortality rates up to 13.6-fold higher than younger patientsiv.
Colpocleisis is a vaginal obliterative procedure for treatment of advanced pelvic organ prolapse in women who do not desire future vaginal intercourse.
EP
Colpocleisis carries benefits including local rather than general anesthesia, shorter operative time, lower blood loss, and faster recovery compared with
AC C
reconstructive urogynecologic procedures. These benefits make colpocleisis an excellent approach for patients who are otherwise not ideal surgical candidates, including elderly women and those with complex medical conditionsv. Multiple studies have demonstrated the effectiveness of colpocleisis in improving pelvic floor symptoms, with success rates ranging from 90-100%vi,vii,viii,ix,x,xi. Additionally, patient satisfaction after colpocleisis is high and rates of regret are quite lowxii,xiii.
ACCEPTED MANUSCRIPT Catanzarite 4
Several single-site case series have reported complications after colpocleisis. Zebede and colleagues described 310 women undergoing Le Fort colpocleisis.
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Five patients (1.6%) experienced intraoperative complications and 47 (15.2%) experienced postoperative complications, for an overall complication rate of 16.8%. Urinary tract infection (UTI) was the most common complication,
SC
occurring in 9% of patients (25/310). The mortality rate was 1.3%, with four
deaths including two pulmonary emboli, one myocardial infarction (MI) occurring
M AN U
42 days after surgery, and one case of sepsis. Ninety-three percent of patients reported that their symptoms were cured or greatly improved. Recurrent prolapse occurred in six patients (1.9%) at a mean of 374 weeksxiv.
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Hullfish et al reported on 94 women undergoing colpocleisis at a single center. Eighteen women (19.1%) experienced complications, with four (4.3%) experiencing UTI. There were no deaths in this series. Sixty percent of women
EP
were “very satisfied” and 35% were “satisfied” after the procedurexv.
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The multi-institutional American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was established as a quality improvement initiative to deepen our understanding of surgical outcomes via prospective collection of data across surgical disciplines. It captures over 240 patient variables from more than 460 participating institutions and is uniquely poised to assess outcomes data.
ACCEPTED MANUSCRIPT Catanzarite 5
In order to better determine risks and complications associated with colpocleisis in a large, generalizable population of women, we utilized the ACS-NSQIP
colpocleisis and to identify risk factors for complications.
SC
Materials & Methods
RI PT
database to assess 30-day medical, surgical, and overall complication rates after
Study design
M AN U
Data from the National Surgical Quality Improvement Program (ACS-NSQIP) Database were retrospectively reviewed for patients undergoing Le Fort colpocleisis from 2005 to 2011 at all institutions participating in NSQIP. Given our use of de-identified data, the Northwestern University Institutional Review
TE D
Board deemed that formal review was not necessary. Patients were identified for inclusion using Current Procedural Terminology (CPT) code 57120 (colpocleisis, Le Fort type). Patients undergoing concomitant sling with colpocleisis were
EP
identified with the additional CPT code 57288 (sling operation for stress incontinence). The data collection methods for NSQIP have been previously
AC C
described and validatedxvi,xvii. A comprehensive analysis of NSQIP data demonstrated high rates of reliabilityxviii.
Outcomes
Primary outcomes were 30-day complication rates, categorized as medical, surgical and overall complications. Medical complications included pneumonia,
ACCEPTED MANUSCRIPT Catanzarite 6 unplanned intubation, ventilator dependence greater than 48 hours, renal insufficiency, acute renal failure, UTI, peripheral neurologic deficiency, cardiac arrest, stroke, blood transfusion, deep venous thrombosis (DVT), pulmonary
RI PT
embolism (PE), and sepsis/septic shock. Surgical complications included superficial, deep, or organ space surgical site infection (SSI) and wound
disruption. Overall complication rates encompassed patients with one or more of
SC
the above complications. 30-day mortality rates were calculated separately.
M AN U
UTI is defined in NSQIP as: (1) fever, symptoms of UTI, and positive urine culture with >105 colonies/mL of no more than two species of organisms or (2) fever or symptoms plus: positive dipstick, pyuria, positive gram stain, two cultures with repeated isolation of >102 colonies/mL of the same uropathogen,
PII: DOI: Reference:
S0022-5347(14)02973-5 10.1016/j.juro.2014.03.040 JURO 11327
To appear in: The Journal of Urology Accepted Date: 10 March 2014 Please cite this article as: Catanzarite T, Rambachan A, Mueller MG, Pilecki MA, Kim JYS, Kenton K, Risk factors for 30-day perioperative complications after Le Fort colpocleisis, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.03.040. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
ACCEPTED MANUSCRIPT
RI PT
Catanzarite 1
SC
Risk factors for 30-day perioperative complications after Le Fort colpocleisis
M AN U
Tatiana Catanzarite, M.D. a, Aksharananda Rambachan, B.A.b, Margaret G. Mueller, M.D. c, Matthew A. Pilecki, B.A. b, John Y.S. Kim, M.D. b, Kimberly Kenton, M.D., M.S.c a
b
c
Department of Obstetrics and Gynecology, Department of Surgery, and Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois
TE D
Descriptive runninghead (max 50 characters): Colpocleisis has low complication/mortality rates.
EP
MESH terms: uterine prolapse/pathology, uterine prolapse/surgery, gynecologic surgical procedures/adverse effects, postoperative complications/etiology, retrospective studies
AC C
Abbreviations and acronyms: UTI = urinary tract infection COPD = chronic obstructive pulmonary disease CHF = congestive heart failure PCI = percutaneous coronary intervention TIA = transient ischemic attack DVT = deep venous thrombosis PE = pulmonary embolism VTE = venous thromboembolism SSI = surgical site infection OR = operating room ASA = American Society of Anesthesiologists ACS-NSQIP = American College of Surgeons National Surgical Quality Improvement Program
ACCEPTED MANUSCRIPT Catanzarite 2 Abstract Purpose. To identify rates of and risk factors for complications after colpocleisis using the National Surgical Quality Improvement Program (ACS-NSQIP)
RI PT
database.
Materials and Methods. Women undergoing Le Fort colpocleisis from 2005 to 2011 were identified in the NSQIP database. Primary outcomes were 30-day
SC
complication rates. Secondary outcomes were risk factors for complications and impact of age and concomitant sling on morbidity. Clinical and procedural
M AN U
characteristics were compared using χ2 and one-way ANOVA tests. Results. Two hundred eighty-three women were identified. Twenty-three women (8.1%) experienced complications. The most common complication was UTI (18/283, 6.4%). There was one death, for a mortality rate of 0.4%. Increased
TE D
complications were associated with age < 75 years (p=0.03), COPD (p=0.03), hemiplegia (p=0.03), disseminated cancer (p=0.03), and open wound infection (p=0.02). Six patients (2.1%) required return to the operating room within 30
EP
days. Complication rates did not differ based on operative time (p=0.78), inpatient status (p=0.24), resident involvement (p=0.35), concomitant sling
AC C
placement (p=0.81), or type of anesthesia (p=0.27). Women undergoing colpocleisis without (n=191) and with (n=92) sling had similar baseline characteristics. Colpocleisis without and with sling had similar rates of complications (7.9% versus 8.7%, p=0.81), UTI (5.8% versus 7.6%, p=0.55), return to the OR (2.1% versus 2.2%, p=0.97), and mortality (0% versus 1.1%, p=0.15).
ACCEPTED MANUSCRIPT Catanzarite 3
Conclusions. Mortality and complication rates after colpocleisis are low, with UTI
placement does not increase 30-day complication rates.
Introduction
RI PT
being the most common postoperative complication. Concomitant sling
SC
Given the aging United States population, steep increases in pelvic floor dysfunction and need for surgical management in elderly patients are
M AN U
anticipatedi,ii; by the year 2050, the demand for treatment of pelvic floor disorders may increase by up to 45%iii. Elderly patients, owing to underlying medical conditions and lower baseline functional status, may experience perioperative
TE D
morbidity and mortality rates up to 13.6-fold higher than younger patientsiv.
Colpocleisis is a vaginal obliterative procedure for treatment of advanced pelvic organ prolapse in women who do not desire future vaginal intercourse.
EP
Colpocleisis carries benefits including local rather than general anesthesia, shorter operative time, lower blood loss, and faster recovery compared with
AC C
reconstructive urogynecologic procedures. These benefits make colpocleisis an excellent approach for patients who are otherwise not ideal surgical candidates, including elderly women and those with complex medical conditionsv. Multiple studies have demonstrated the effectiveness of colpocleisis in improving pelvic floor symptoms, with success rates ranging from 90-100%vi,vii,viii,ix,x,xi. Additionally, patient satisfaction after colpocleisis is high and rates of regret are quite lowxii,xiii.
ACCEPTED MANUSCRIPT Catanzarite 4
Several single-site case series have reported complications after colpocleisis. Zebede and colleagues described 310 women undergoing Le Fort colpocleisis.
RI PT
Five patients (1.6%) experienced intraoperative complications and 47 (15.2%) experienced postoperative complications, for an overall complication rate of 16.8%. Urinary tract infection (UTI) was the most common complication,
SC
occurring in 9% of patients (25/310). The mortality rate was 1.3%, with four
deaths including two pulmonary emboli, one myocardial infarction (MI) occurring
M AN U
42 days after surgery, and one case of sepsis. Ninety-three percent of patients reported that their symptoms were cured or greatly improved. Recurrent prolapse occurred in six patients (1.9%) at a mean of 374 weeksxiv.
TE D
Hullfish et al reported on 94 women undergoing colpocleisis at a single center. Eighteen women (19.1%) experienced complications, with four (4.3%) experiencing UTI. There were no deaths in this series. Sixty percent of women
EP
were “very satisfied” and 35% were “satisfied” after the procedurexv.
AC C
The multi-institutional American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) was established as a quality improvement initiative to deepen our understanding of surgical outcomes via prospective collection of data across surgical disciplines. It captures over 240 patient variables from more than 460 participating institutions and is uniquely poised to assess outcomes data.
ACCEPTED MANUSCRIPT Catanzarite 5
In order to better determine risks and complications associated with colpocleisis in a large, generalizable population of women, we utilized the ACS-NSQIP
colpocleisis and to identify risk factors for complications.
SC
Materials & Methods
RI PT
database to assess 30-day medical, surgical, and overall complication rates after
Study design
M AN U
Data from the National Surgical Quality Improvement Program (ACS-NSQIP) Database were retrospectively reviewed for patients undergoing Le Fort colpocleisis from 2005 to 2011 at all institutions participating in NSQIP. Given our use of de-identified data, the Northwestern University Institutional Review
TE D
Board deemed that formal review was not necessary. Patients were identified for inclusion using Current Procedural Terminology (CPT) code 57120 (colpocleisis, Le Fort type). Patients undergoing concomitant sling with colpocleisis were
EP
identified with the additional CPT code 57288 (sling operation for stress incontinence). The data collection methods for NSQIP have been previously
AC C
described and validatedxvi,xvii. A comprehensive analysis of NSQIP data demonstrated high rates of reliabilityxviii.
Outcomes
Primary outcomes were 30-day complication rates, categorized as medical, surgical and overall complications. Medical complications included pneumonia,
ACCEPTED MANUSCRIPT Catanzarite 6 unplanned intubation, ventilator dependence greater than 48 hours, renal insufficiency, acute renal failure, UTI, peripheral neurologic deficiency, cardiac arrest, stroke, blood transfusion, deep venous thrombosis (DVT), pulmonary
RI PT
embolism (PE), and sepsis/septic shock. Surgical complications included superficial, deep, or organ space surgical site infection (SSI) and wound
disruption. Overall complication rates encompassed patients with one or more of
SC
the above complications. 30-day mortality rates were calculated separately.
M AN U
UTI is defined in NSQIP as: (1) fever, symptoms of UTI, and positive urine culture with >105 colonies/mL of no more than two species of organisms or (2) fever or symptoms plus: positive dipstick, pyuria, positive gram stain, two cultures with repeated isolation of >102 colonies/mL of the same uropathogen,
