Abstract
Abstract
Introduction
Common vaginal approaches for correction of apical pelvic organ prolapse include vaginal sacrospinous ligament vault suspension, high uterosacral ligament vault suspension, and McCall culdoplasty. High uterosacral ligament vault suspension and McCall culdoplasty require peritoneal cavity entry through the vagina, manipulation of the bowel, and the tying down of suture within the peritoneal cavity, usually under limited visualization. These techniques may potentially increase the risk of GI complications compared to extraperitoneal vaginal vault suspensions such as sacrospinous ligament fixation.
The most common abdominal surgery for correction of apical prolapse is abdominal (open or laparoscopic) sacral colpopexy. 7 This procedure involves entering the peritoneal cavity and attaching mesh from the vagina to the anterior longitudinal ligament of the sacrum. Although several randomized trials have demonstrated that extraperitoneal vaginal vault suspensions have lower morbidity, shorter operating time, shorter length of admission, and lower cost compared to the more effective and durable sacral colpopexy,8–11 no study has directly compared abdominal sacral colpopexy to intraperitoneal vaginal vault suspension.
A case series describing three patients who experienced small bowel obstruction after uterosacral ligament vaginal vault suspension was published, 12 however, the incidence of these complications is unknown. Therefore, the objective of this study is to compare the incidence of GI complications, specifically intraoperative bowel injury and ileus and small bowel obstruction, in patients after sacral colpopexy and intraperitoneal vaginal vault suspension.
Materials and Methods
The Institutional Review Board of the Cleveland Clinic approved this study. A retrospective review of all subjects undergoing either intraperitoneal vaginal vault suspension (uterosacral ligament vaginal vault suspension or McCall culdoplasty) or abdominal sacral colpopexy (open or laparoscopic) to correct apical pelvic organ prolapse from January 1, 2001 through December 31, 2003 was performed. All surgeries were performed by 1 of 3 attending surgeons at the Cleveland Clinic with assistance from a urogynecology fellow or senior obstetrics and gynecology resident. Patients were excluded if they underwent only an extraperitoneal vaginal vault suspension (sacrospinous ligament fixation or iliococcygeus vaginal vault suspension), and/or colpocleisis, as these procedures do not require intraperitoneal access and are thought to have minimal risk of postoperative GI dysfunction. Additional operations combining intraperitoneal vaginal vault suspension and laparoscopy (i.e., laparoscopic Burch urethropexy) were excluded. Patients who underwent concomitant rectopexy or planned bowel resection were also excluded, given that these procedures may be independently associated with GI complications.
The techniques of laparoscopic and abdominal sacral colpopexy are similar and have been previously reported. 13 In the current study, two separate 3 × 15 cm pieces of polypropylene (n = 75) or mersilene mesh (n = 15) were attached to the anterior and posterior vaginal walls and sutured to the anterior longitudinal ligament at or just below the sacral promontory, followed by closure of peritoneum over the mesh. If an incidental enterotomy (n = 1) was noted, then a solvent dehydrated cadaveric fascia lata (Tutoplast, Mentor Corp, Santa Barbara, CA) was substituted in place of the mesh. The uterosacral ligament vaginal vault suspension was performed as previously described.14,15 After the intra-abdominal cavity was accessed, the bowel was packed cephalad with moistened laparotomy sponges, a Breisky-Navratil retractor was used to displace the rectum, and the uterosacral ligaments were palpated at the level of the ischial spine. Typically, 2–3 sutures using a combination of 0-polypropylene and 0-polydiaxanone were placed through the uterosacral ligament above the level of the ischial spine bilaterally. The delayed absorbable sutures were then placed through the vaginal epithelium at the level of the new apex and the permanent sutures were placed through the vaginal muscularis of the anterior and posterior vagina. Alternatively, 0-polydiaxanone suture was placed through the uterosacral ligament above the ischial spine, then through the anterior and posterior vaginal epithelium, and 0-polypropylene suture was placed through the uterosacral ligament below the ischial spine, reefed across the posterior peritoneum incorporating the contralateral uterosacral ligament, thereby plicating both uterosacral ligaments in the midline. To avoid bowel entrapment while tying the sutures down, patients were placed in steep Trendelenburg position, the potential space between the uterosacral ligament and vaginal vault was obliterated by reapproximating the vaginal apex to the placed suture prior to tying, and nitrous oxide anesthetics were avoided to prevent resultant bowel distention. Concomitant prolapse and anti-incontinence procedures and suprapubic tube insertions were performed as deemed necessary by the primary surgeon.
The primary outcome of this study was GI complications, including intraoperative bowel injury, postoperative ileus, or bowel obstruction within the first 6 postoperative weeks. Postoperative ileus was defined as nausea or vomiting with abdominal distention or pain occurring beyond the initial 24 hours of surgery, which resolved without surgical intervention. Small bowel obstruction was defined as nausea or vomiting with abdominal distention or pain occurring beyond the initial 24 hours of surgery, with radiographic evidence (air–fluid levels or small bowel distention with a transition point) of obstruction, or surgery demonstrating mechanical obstruction.
Demographics, previous and concurrent surgical procedures, short-term complications, and subsequent surgeries were extracted from dictated operative reports, discharge summaries, and emergency room and clinic visits, using the system-wide electronic medical record. Postoperative ileus or bowel obstruction was identified using International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) codes 560.1 (ileus), 560.81 (obstruction, intestine, with adhesions [intestinal] [peritoneal]), 560.9 (obstruction, GI), 997.4 (obstruction, intestinal caused by procedure), 997.5 (obstruction, intestinal caused by procedure involving the urinary tract), and 569.49 (obstruction, rectum), and was confirmed by reviewing the health system-wide electronic medical record. In order to evaluate the effectiveness of this search strategy, a thorough review of 10% of subject charts from each group who did not have codes that identified them as having a GI complication, was performed. A detailed review of these 53 charts revealed no additional cases of intraoperative or postoperative GI complication (ileus, small bowel obstruction, enterotomy).
Categorical and continuous data were evaluated using the Fisher's Exact Test and the Student's t-test as appropriate. Logistic regression was used to control for potential confounding variables. All statistical tests were two tailed; p < 0.05 was considered statistically significant. Statistical analysis was performed using JMP 8.0 (SAS Institute, Cary, NC).
Results
Five hundred and nineteen subjects underwent either sacral colpopexy or intraperitoneal vaginal vault suspension during the study period. Ninety-seven subjects underwent sacral colpopexy including 59 (61%) via the abdominal approach and 38 (39%) via the laparoscopic approach. Four hundred and twenty-two subjects underwent a vaginal vault suspension including: 213 (51%) uterosacral ligament vaginal vault suspensions, 183 (43%) McCall's culdoplasties, and 26 (6%) combined uterosacral ligament vaginal vault suspension and McCall procedures. Means (±SD) were: age, 61.4 (±12.4) years and body mass index, 27.1 (±5.3) kg/m2 and median (range) parity was 3 (0–10) with no significant differences between groups with the exception of slightly younger subjects in the sacral colpopexy group (58.8 versus 62.0 years, p = 0.02). Subjects who underwent sacral colpopexy were more likely to be Caucasian. Subjects who underwent vaginal vault suspension were more likely to undergo concurrent hysterectomy and to have shorter operating times (both p < 0.0001) (Table 1).
Data are presented as mean (± standard deviation) unless otherwise indicated.
BMI, body–mass index.
The incidence of intraoperative bowel complications was greater with sacral colpopexy than with vaginal vault suspension (2/97 [2.1% 95% CI 0.1–7.7] versus 0/422 [0.0% 95% CI 0–1.1], p = 0.04). One patient suffered an enterotomy during an open abdominal sacral colpopexy that was repaired during the initial surgery and was not associated with further morbidity. The second patient developed fecal peritonitis in the postoperative period after laparoscopic sacral colpopexy, presumably from an unrecognized bowel injury.
Using ICD-9 codes, 64 subjects were identified as having potentially experienced GI complications during the postoperative period. Of these patients, 30 received these codes preoperatively because of diagnoses of defecatory dysfunction (n = 24), abdominal pain (n = 4), or rectal prolapse (n = 2). Seventeen received these codes because of concomitant sphincteroplasty (n = 3), postoperative ureteral or urethral obstruction (n = 7), or other postoperative complication (n = 7). Eight additional subjects did not meet the criteria for developing a GI complication. The 8 remaining patients met our criteria and definition for a postoperative GI complication.
The incidence of postoperative GI complications was significantly higher (4.1% [95% CI 2.6–12.3] versus 0.47% [95% CI .01–1.8], p = 0.01) in subjects undergoing sacral colpopexy than in subjects undergoing vaginal vault suspension (Table 2). The symptoms of ileus were mild, and all resolved with conservative management including bowel rest and intravenous fluids. The incidence of small bowel obstruction was similar (1% vs. 0.22%, p = 0.33) between the sacral colpopexy and vaginal vault suspension groups, respectively. One subject in the sacral colpopexy group developed significant nausea, vomiting, abdominal pain, and distention and had a KUB demonstrating small bowel obstruction. Her symptoms resolved spontaneously with bowel rest. One subject in the vaginal vault suspension group underwent total vaginal hysterectomy, bilateral salpingo-oophorectomy, McCall culdoplasty, iliococcygeus vault suspension, anterior and posterior colporrhaphy, perineorrhaphy, cystoscopy, and suprapubic tube placement. She developed nausea, vomiting, and abdominal pain and distention in the early postoperative period and presented to the emergency room 9 days after the prolapse repair. A KUB demonstrated a small bowel obstruction and she underwent exploratory laparotomy, small bowel resection with reanastomosis, and lysis of adhesions. Pathology revealed focal perforation of the small intestine segment with organizing ulcer of the overlying small intestine mucosa.
Data are presented as n (%).
Although most symptoms were mild, the median (range) length of hospitalization for patients with perioperative GI complications was significantly longer than for those who did not have GI complications (3 [0–43] days versus 2 [0–9] days; p < 0.001). It was not possible to demonstrate differences in the rates of GI complications between the open and laparoscopic sacral colpopexy groups (6.8% [95% CI 2.2–16.6] vs. 5.3% [95% CI 0.5–18.2], p = 1.0).
Logistic regression was performed to control for potential confounders. The following variables were considered for model inclusion: concurrent hysterectomy, lysis of adhesions, operative time, and procedure. Lysis of adhesions was excluded as this is often not coded or described during vaginal surgery. Ultimately, there was no difference in the model outcomes whether or not lysis of adhesion was included. After controlling for operating time, concurrent hysterectomy, and procedure type, subjects treated with sacral colpopexy had a significantly greater risk of GI complication than the vaginal vault suspension group (adjusted OR 13.9, [95% CI 1.7–161], p = 0.01). Furthermore, operative time and concurrent hysterectomy were not independently associated with GI complications (p > 0.43).
Discussion
Postoperative ileus and small bowel obstruction are thought to occur secondary to inhibitory neural reflexes, inflammation, and neurohormonal peptides such as nitric oxide. 16 Most surgeons consider postoperative gut dysmotility a normal and perhaps obligatory response to surgery. However, data suggest that gastric and small intestinal activity return within hours of surgery, and that colonic activity returns in 1–2 days.16–18
Although it is not a surprising finding that GI complications occur with greater frequency after sacral colpopexy than after vaginal vault suspension, these data add to information available in the existing literature. Karram et al. reported complications from 202 patients undergoing high uterosacral ligament vaginal vault suspension, and found a small bowel injury rate of 0.5%, as well as a rate of 0.5% for postoperative ileus secondary to pelvic abscess requiring exploratory laparotomy, abscess drainage, and colonic diversion, 19 which is similar to the current findings. The rate of bowel injury (enterotomy or proctotomy) ranges from 0.4 to 2.5% according to a comprehensive review of abdominal sacral colpopexies, 20 similar to the rate of bowel injury seen after laparoscopic sacral colpopexy (1.8%). 21
Rates of postoperative ileus and small bowel obstruction after sacral colpopexy are better studied, and are similar to the current findings. In a comprehensive review of published data on sacral colpopexy, the median (range) rate of post operative ileus was 3.6% (1.1%–9.3%). 20 The median (range) rate of patients requiring reoperation for small bowel obstruction was 1.1% (0.6%–8.6%). Of the 322 women participating in the Colpopexy and Urinary Reduction Efforts (CARE) study, 5.9% had ileus or small bowel obstruction, with 1.2% requiring reoperation to relieve small bowel obstruction. 22 Retrospective studies of laparoscopic sacral colpopexy report a postoperative intestinal obstruction rate of 0.3%–1.8%.13,23
The current finding of increased risk of GI complications in patients undergoing sacral colpopexy compared to intraperitoneal vaginal vault suspension is probably caused by the difference in procedure techniques and resultant adhesion formation. Sacral colpopexy, whether via the abdominal or laparoscopic route, requires intra-abdominal access, dissection of the peritoneum covering the anterior and posterior vaginal walls, and the attachment of mesh. Previous studies demonstrate increased adhesion formation in open procedures compared to laparoscopic and vaginal procedures.24–26 This difference can probably be attributed to the increased disruption of peritoneal surfaces that occurs with open surgery. Additionally, the presacral dissection that takes place in sacral colpopexy may interrupt nerve pathways, causing inhibitory neural reflexes to increase inhibitory sympathetic activity in the GI tract, potentially resulting in ileus or obstruction.
Patients undergoing vaginal surgery are less likely to experience adhesion formation because of the lack of an abdominal incision, less peritoneal dissection, less manipulation of bowel, and the absence of mesh. There is, however, the potential for small bowel injury or rectal constriction to occur because the suspension sutures are frequently tied down blindly without direct retraction of the bowel. This may result in either incorporation of bowel in the suspension, or incomplete elevation with a suture bridge that has the potential to result in future trapping of bowel. Furthermore, concomitant procedures, such as retropubic midurethral slings and insertion of suprapubic tubes, have the potential to cause GI complications.27,28
Strengths of this study lie in the large number of subjects and relatively standardized surgical technique. This study is limited by the low number of cases of GI complications and the inherent biases of a retrospective study design. Because many physicians associate ileus and small bowel obstruction with open surgery, these conditions could have been suspected and coded more often. Furthermore, as these patients were not randomized to the surgical group, patients who underwent sacral colpopexy may represent a different complication risk profile. This study relied on the use of the electronic medical record and ICD-9 coding, which limited the investigation to patients who received postoperative care at the Cleveland Clinic. It is not known how many patients received additional care at outside institutions. Multiple codes were used to capture as many cases as possible, though this technique was associated with a poor predictive value. The sensitivity of this search strategy is unknown and may be associated with an underestimation of the incidence of GI complications. Moreover, the software used to identify ICD-9 codes only stores the first four ICD-9 codes for each patient, potentially resulting in omission of a GI complication. However, only 1.5% of gynecology patients at the Cleveland Clinic have more than four ICD-9 codes, making this search strategy effective. Finally, the follow-up period was limited to 6 weeks postoperatively, excluding patients with delayed small bowel obstruction, which can occur many months to years later.
Conclusions
Intraoperative bowel injury and postoperative GI complications are more common after sacral colpopexy than after intraperitoneal vaginal vault suspension, although there was no difference in the incidence of small bowel obstruction between groups. The overall incidence of GI complications is low, and the majority are cases of ileus that resolve with bowel rest alone. Whether this is an inherent risk of the procedure and/or approach or whether it is a consequence of a greater degree of pelvic floor dysfunction or associated demographic or comorbidities in those patients who receive sacral colpopexy is unknown. These data are important in developing a risk and benefit model for vaginal versus abdominal operations for pelvic organ prolapse.
Footnotes
Disclosure Statement
Mark Walters is a consultant and lecturer for Americal Medical Systems, Inc.; Marie Fidela Paraiso is a consultant for Coloplast, Inc. No competing financial conflicts exist for the other authors.
