Major postoperative complications following surgical procedures for pelvic organ prolapse: a secondary database analysis of the American College of Surgeons National Surgical Quality Improvement Program

doi:10.1016/j.ajog.2017.05.052

American Journal of Obstetrics and Gynecology

Volume 217, Issue 5, November 2017, Pages 608.e1-608.e17

Presented at the 43rd annual meeting of the Society of Gynecologic Surgeons, San Antonio, TX, March 26-29, 2017.

https://doi.org/10.1016/j.ajog.2017.05.052 Get rights and content

Background

Surgical approaches to the correction of pelvic organ prolapse include abdominal, vaginal, and obliterative approaches. These approaches require vastly different anatomical dissections, surgical techniques, and operative times and are often selected by the patient and surgeon to match preoperative multimorbidity and ability of the patient to tolerate the stress of surgery.

Objective

We sought to describe the occurrence of postoperative complications occurring after 3 different surgical approaches to treat pelvic organ prolapse: vaginal, abdominal, and obliterative.

Study Design

We conducted a secondary database analysis of the 2006 through 2014 American College of Surgeons National Surgical Quality Improvement Program participant use data files to analyze patients undergoing procedures for pelvic organ prolapse based on Current Procedural Terminology codes. Women were categorized into 3 surgical approaches to prolapse: vaginal, abdominal, and obliterative. Concomitant hysterectomy and sling were also examined. The primary outcome was a composite of 30-day major postoperative complications.

Results

A total of 33,416 women were included in our final analysis: 24,928 vaginal procedures, 6834 abdominal (4461 minimally invasive) procedures, and 1654 obliterative procedures. Concomitant hysterectomies and slings were performed in 17,380 (52.0%) and 10,896 (32.6%) of prolapse procedures. The overall prevalence of composite 30-day major postoperative complications was 3.1% (n/N = 1028/33,416). There were 13 perioperative deaths (0.04%) with no difference in the surgical approaches (P = .55). There were no differences in major postoperative complications between vaginal and abdominal procedures (3.0% vs 3.0%; P = .71). Women undergoing obliterative procedures had an occurrence of major postoperative complications of 5.0% (n/N = 83/1654), P < .001.

Conclusion

The occurrence of major postoperative complications after prolapse surgery is rare. We did not find a significant difference in major postoperative complications between vaginal and abdominal surgeries for pelvic organ prolapse. In this well-characterized cohort of patients who self-selected surgical approach, women undergoing obliterative surgery had more postoperative complications, likely attributed to increased age and multimorbidity.

Introduction

Pelvic organ prolapse (POP) is a hernia of the vagina that presents as a symptomatic vaginal bulge in women protruding past the vaginal hymen that can be felt with wiping, standing, or sitting.1, 2 POP is a highly prevalent condition with a symptomatic bulge reported by 2.9% of US women (95% confidence interval [CI], 2.1–3.7%).³ There are many options for treatment of POP that include both nonsurgical (pelvic floor muscle exercises and pessaries) and surgical management.⁴ The cumulative lifetime risk of undergoing surgery for POP in the United States is 12.6% with the highest rates of surgery in women aged 70-79 years.⁵

Procedures for POP are elective and therefore preference-sensitive. Some women will select for nonsurgical treatments while others will pursue surgical correction. Surgical approaches to the correction of POP include abdominal, vaginal, and obliterative approaches. These approaches require vastly different anatomical dissections, surgical techniques, and operative times and are often selected by the patient and surgeon to match preoperative multimorbidity and ability of the patient to tolerate the stress of surgery. Therefore, to adequately counsel a woman on which surgical option is best for her, if any, it is important to know the associated risks with each procedure, including mortality and major postoperative morbidity. Most studies that report on complications from POP procedures are from a single institution or focused primarily on intraoperative complications relating to visceral organ injuries.6, 7, 8, 9, 10, 11, 12, 13, 14 Limited data are available regarding the occurrence of major postoperative medical complications following these different approaches to POP surgery (vaginal, abdominal, and obliterative) across multiple institutions.

The primary objective of this study was to use a validated, large, multicentered outcomes database, the 2005 through 2014 American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) participant use data files, to describe the occurrence of 30-day major medical postoperative complications following 3 surgical approaches to POP (vaginal, abdominal, and obliterative). The secondary objective of this study was to compare the occurrence of 30-day surgical site infections (SSI) in the 3 surgical approaches to POP.

Section snippets

Materials and Methods

We conducted a secondary database analysis of the 2006 through 2014 ACS NSQIP participant use data files to analyze women undergoing procedures for POP performed by gynecologic services. The ACS NSQIP collects uniform data on patients undergoing surgical procedures. Hospitals voluntarily elect to participate in the ACS NSQIP. Information entered into ACS NSQIP is collected by a formal chart review process of the inpatient record that includes a 30-day postoperative follow-up.¹⁵ Hospitals

Results

A total of 33,416 women met criteria and were included in our final analyses, including 24,928 vaginal procedures, 6834 abdominal (4461 minimally invasive) procedures, and 1654 obliterative procedures. Concomitant hysterectomies were performed in 17,380 (52.0%) POP procedures (63.2% of abdominal procedures, 50.2% of vaginal procedures, and 32.4% of obliterative procedures; P <.001). Concomitant slings were performed in 10,896 (32.6%) of POP procedures (34.3% of abdominal procedures, 32.2% of

Comment

The occurrence of major postoperative complications after POP surgery is uncommon and even older women (≥80 years) undergo these procedures with few major complications. The occurrence of major medical complications did not differ between vaginal and abdominal approaches to POP correction. Major complications were higher in women who underwent obliterative POP procedures and classic measures of adjusting for preoperative medical comorbidity did not fully explain these increased complications.

Acknowledgment

The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) and the hospitals participating in the ACS NSQIP are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.

References (28)

K.J. Stepp et al.
Incidence of perioperative complications of urogynecologic surgery in elderly women
Am J Obstet Gynecol
(2005)
V.W. Sung et al.
Effect of patient age on increasing morbidity and mortality following urogynecologic surgery
Am J Obstet Gynecol
(2006)
C.A. Unger et al.
Incidence of adverse events after uterosacral colpopexy for uterovaginal and posthysterectomy vault prolapse
Am J Obstet Gynecol
(2015)
A.J. Hill et al.
Perioperative adverse events associated with colpocleisis for uterovaginal and posthysterectomy vaginal vault prolapse
Am J Obstet Gynecol
(2016)
C.A. Unger et al.
Perioperative adverse events after minimally invasive abdominal sacrocolpopexy
Am J Obstet Gynecol
(2014)
W.G. Henderson et al.
Design and statistical methodology of the National Surgical Quality Improvement Program: why is it what it is?
Am J Surg
(2009)
V. Velanovich et al.
Accumulating deficits model of frailty and postoperative mortality and morbidity: its application to a national database
J Surg Res
(2013)
T.N. Robinson et al.
Frailty for surgeons: review of a National Institute on Aging Conference on Frailty for Specialists
J Am Coll Surg
(2015)
W.B. Chow et al.
American College of Surgeons National Surgical Quality Improvement Program. Optimal preoperative assessment of the geriatric surgical patient: a best practices guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society
J Am Coll Surg
(2012)
S. Mohanty et al.
Optimal perioperative management of the geriatric patient: a best practices guideline from the American College of Surgeons NSQIP and the American Geriatrics Society
J Am Coll Surg
(2016)

P. Abrams et al.

Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence

Neurourol Urodyn

(2010)

M.D. Barber et al.

Defining success after surgery for pelvic organ prolapse

Obstet Gynecol

(2009)

I. Nygaard et al.

Prevalence of symptomatic pelvic floor disorders in US women

JAMA

(2008)

J.L. Whiteside et al.

Goals, symptoms, signs, and treatments among women with pelvic floor disorders

Female Pelvic Med Reconstr Surg

(2014)

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: The authors report no conflict of interest.

: Cite this article as: Erekson E, Murchison RL, Gerjevic KA, et al. Major postoperative complications following surgical procedures for pelvic organ prolapse: a secondary database analysis of the American College of Surgeons National Surgical Quality Improvement Program. Am J Obstet Gynecol 2017;217:608.e1-17.

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Meeting PaperSGS PaperMajor postoperative complications following surgical procedures for pelvic organ prolapse: a secondary database analysis of the American College of Surgeons National Surgical Quality Improvement Program

Background

Objective

Study Design

Results

Conclusion

Introduction

Section snippets

Materials and Methods

Results

Comment

Acknowledgment

Am J Obstet Gynecol

Am J Obstet Gynecol

Am J Obstet Gynecol

Am J Obstet Gynecol

Am J Obstet Gynecol

Am J Surg

J Surg Res

J Am Coll Surg

J Am Coll Surg

J Am Coll Surg

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Meeting Paper
SGS Paper
Major postoperative complications following surgical procedures for pelvic organ prolapse: a secondary database analysis of the American College of Surgeons National Surgical Quality Improvement Program