Complications and Functional Results after Ileoanal Pouch Formation in Obese Patients

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J Gastrointest Surg (2008) 12:668 674 DOI 10.1007/s11605-008-0465-3 Complications and Functional Results after Ileoanal Pouch Formation in Obese Patients R. P. Kiran & F. H. Remzi & V. W. Fazio & I. C. Lavery & J. M. Church & S. A. Strong & T. L. Hull Received: 22 May 2007 /Accepted: 6 January 2008 /Published online: 29 January 2008 # 2008 The Society for Surgery of the Alimentary Tract Abstract Objective Ileoanal pouch formation (IPAA) can be technically challenging in obese patients, and there is little data evaluating results after the procedure in these patients. We compare outcomes for patients with a body mass index (BMI) 30 undergoing IPAA when compared with those for patients with BMI <30. Methods Retrospective analysis of prospectively accrued data for patients with BMI 30 undergoing IPAA. Patient and disease-related characteristics, complications, long-term function, and quality of life (QOL) using the Cleveland Global Quality of Life scale (CGQL) were determined for this group of patients (group B) and compared with those for patients with BMI <30 (group A). Kruskal Wallis and Wilcoxon rank sum tests were used to compare quantitative or ordinal data and chi-square or Fisher s exact tests for categorical variables. Long-term mortality and complication rates were estimated using the Kaplan Meier method with group comparisons performed using log rank tests. Results There were 345 patients (median BMI 32.7) in group B and 1,671 patients in group A. When the cumulative risk of complications over 15 years was compared, group B patients had a significantly higher chance of getting a complication (94.9% vs 88%, p=0.006). The rates of pelvic sepsis (6.7% vs 5.3%, p=0.3), pouchitis (58.1 vs 54.4%, p=0.9), pouch failure (6% vs 4.5%, p=0.9), and hemorrhage (5.6% vs 4.8%, p=0.7) were similar for group B and group A. Group B patients, however, had a significantly higher risk of the development of wound infection (18.8% vs 8.1%, p<0.001) and anastomotic separation (10.4% vs 5.4%, p<0.001), whereas group A patients had a higher rate of development of obstruction over time (26.7% vs 22.3%, p=0.02). Long-term outcome including QOL and function after 15 years was comparable between groups. Conclusions Although technically demanding, IPAA can be undertaken in obese patients with acceptable morbidity. Good long-term functional results and QOL that is comparable to nonobese patients may be anticipated. Keywords Ileoanal pouch formation. Obese patients. Complications. Long-term function. Quality of life Introduction The ileoanal pouch (IPAA) offers long-term continence and quality of life (QOL) for patients with ulcerative colitis R. P. Kiran (*) : F. H. Remzi : V. W. Fazio : I. C. Lavery : J. M. Church : S. A. Strong : T. L. Hull Department of Colorectal Surgery, Cleveland Clinic Foundation, Desk A30, 9500 Euclid Avenue, Cleveland, OH 44122, USA e-mail: madhurkiran@hotmail.com (UC) undergoing restorative proctocolectomy (RP). 1,2 Indications of the technique have been broadened to include its use in indeterminate colitis (IC), 3,4 familial adenomatous polyposis (FAP), 5 and selected patients with Crohn s disease (CD) 6 desiring maintenance of continence. The prevalence of obesity among US adults has doubled since 1990. 7 Although previous studies have demonstrated that obesity by itself does not correlate with adverse outcomes in general surgical operations, 8 10 there is a paucity of available literature on outcomes in obese patients undergoing IPAA. The relevance of this data is especially important as IPAA may be technically challenging in obese patients. As there have been few reports in the literature examining the application of this technique in this group, we evaluate

J Gastrointest Surg (2008) 12:668 674 669 the differences in the preoperative and perioperative factors of patients with BMI 30 and of patients with BMI <30 and compare the long-term functional results and QOL in the two groups. Methods All patients undergoing IPAA at our institution are prospectively accrued into an institutional review board (IRB)-approved pouch database. Patients with a body mass index (BMI) 30 (group B) in the database were retrospectively identified from the database and compared with patients with BMI <30 (group A). Differences in demographics, preoperative factors, indication for surgery, final pathological diagnosis, and surgical factors including type of anastomosis, use of defunctioning stoma, and configuration of the pouch were determined. The two groups were also compared to determine any differences in the incidence of complications, function, and QOL over time. Complications, long-term functional outcome, and QOL for this group of patients at 5, 10, and 15 years were analyzed. The function of the pouch was determined by evaluation of the number of daytime and nighttime bowel movements, incontinence, urgency, and pad usage as reported by patients at each follow-up. Incontinence and urgency were graded as never, rarely, sometimes, mostly, and always. Complications, long-term functional outcome, and QOL for this group of patients at 5, 10, and 15 years were analyzed. QOL was assessed by the Cleveland Global Quality of Life scale (CGQL), which has been previously described in patients undergoing restorative proctocolectomy. 11 Patients rated each of three items (current QOL, current quality of health [QOH], and current energy level [CEL]) on a scale of 0 10, 0 being the worst and 10 the best. The sum of the three scores divided by 30 gave the CGQL score (possible range 0 1). The three components of CGQL and the overall CGQL score at different time points were evaluated. The availability of long-term functional and QOL data varies greatly among the patients in the database. Among patients with available data, patterns with respect to the timing of data collection also varied greatly. To overcome the inconsistencies and assess these outcomes at specified times after surgery of 1, 5, 10, and 15 years, we defined windows around these time points of 3 months, 1 year, 2 years, and 2 years, respectively, and for each patient, we captured the measurement taken closest to the target time point and still within the defined window. Within any time point and its acceptable window, only a fraction of the patients had data available. Statistical methods Only patients with complete data pertaining to BMI were included in the analysis. Data that were missing for some patients were excluded during the particular analysis. Data is reported as the mean±standard deviation (SD) for parametric data and as the median (interquartile range [IQR]) for nonparametric data. With respect to quantitative or ordinal data, groups were compared using Kruskal Wallis and Wilcoxon rank sum tests. Comparisons with respect to categorical variables were performed using chi-square, or alternatively, Fisher s exact test when chi-square assumptions were of questionable validity based on low frequencies or group sizes. For long-term functional and QOL data, selected time points were analyzed separately because of inconsistencies in the sets of patients with data available for analysis. Long-term mortality and complication rates were estimated using the Kaplan Meier method with group comparisons performed using log rank tests. p values for individual comparisons are reported. A level of α=0.05 was used to define significance; although with several group comparisons performed, some false-positive tests are to be expected. For analyses of functional and QOL outcomes that include four time points, Bonferroni-corrected significance levels of 0.0125 were applied. Results There were 345 patients with BMI 30 in the database with a median BMI of 32.7 and 1,671 patients in group A (median BMI 23.8). Although all patients who were overweight were advised to lose weight before surgery, data pertaining to the amount and weight lost, if any, in these patients is not available. Baseline characteristics for groups A and B are given in Table 1. As a number of patients have more than one indication for surgery, the predominant indication for surgery was listed as primary and any additional indications as secondary. The most common primary indications in group B were desire for continence after prior colectomy (35.7%), steroid dependency or toxicity (34.8%), presence of dysplasia (12.5%), and failure of medical therapy (9.9%). Patients in groups A and B had similar primary and secondary indications for surgery (p=0.09). Final pathological diagnosis (p=0.14) was also similar between groups. The subset with a final pathologic diagnosis of Crohn s disease includes patients who developed a secondary diagnosis of Crohn s disease after IPAA. Based on a review of our experience in this group of patients, 12 we also currently consider IPAA in a select group of patients with isolated colonic Crohn s disease who have no evidence of perianal and small bowel involvement.

670 J Gastrointest Surg (2008) 12:668 674 Table 1 Comparison of Patients with BMI <30 and 30 Variable BMI <30 (n=345) BMI 30 (n=1,671) p value Age (mean±sd) 36.8±13.1 42.3±12.3 <0.001* Female gender, n (%) 742 (44.5) 144 (40.6) 0.2 Previous steroids and immunosuppressive medication, n (%) 1,179 (70.5) 272 (77.3) 0.01* Comorbidity, n (%) 600 (35.9) 261 (74.1) <0.001* Resection, n (%) Completion proctectomy 604 (36.1) 126 (35.8) 0.9 Total proctocolectomy 1,069 (63.9) 226 (64.2) Pouch configuration, n (%) J 1,437 (85.9) 310 (88.6) 0.19 S 235 (14.1) 40 (11.4) Anastomosis, n (%) Handsewn 276 (16.5) 35 (10.1) 0.003* Stapled 1,394 (83.5) 313 (89.9) Proximal diversion, n (%) False 250 (14.9) 50 (14.2) 0.72 True 1,423 (85.1) 302 (85.8) ASA class, n (%) Class I 5 (5.7) 2 (4.5) 0.53 Class II 61 (70.1) 26 (59.1) Class III 20 (23) 15 (34.1) Class IV 1 (1.1) 1 (2.3) Intraoperative transfusion, n (%) 269 (16.1) 57 (16.2) 0.96 Postoperative transfusion, n (%) 104 (6.2) 24 (6.8) 0.7 Final pathological diagnosis, n (%) MUC 995 (59.5) 208 (59.3) 0.14 Indeterminate colitis 251 (15) 49 (14) Indeterminate favoring Crohn s 44 (2.6) 3 (0.9) Indeterminate favoring MUC 182 (10.9) 46 (13.1) Crohn s 62 (3.7) 8 (2.3) FAP 121 (7.2) 31 (8.8) Cancer 6 (0.4) 4 (1.1) Not documented 2 (0.1) 0 (0) Other 8 (0.5) 2 (0.6) MUC: mucosal ulcerative colitis *p<0.05 Pouch configuration, use of proximal diversion, and use of intraoperative or postoperative blood transfusion was similar in groups A and B. A significantly higher proportion of group B patients was on steroids and immunosuppressive medication preoperatively, and as may be expected, had associated comorbidity. However, the ASA class distribution was similar in the two groups. A significantly lower proportion of group B patients had a handsewn anastomosis when compared with group A patients. The preferred technique is a stapled anastomosis at our institution. Mucosectomy is performed when a handsewn anastomosis is performed and in patients with FAP with rectal cancer and UC patients with dysplasia or cancer in the lower rectum. Complications The estimated cumulative risk of any complication occurring for group B was 82.1% after 5 years of follow-up, 85.3% after 10 years of follow-up, and 94.9% after 15 years of follow-up. At 5 years after the procedure, the commonest complications were pouchitis and anastomotic stricture. After 15 years of follow-up, pouchitis continued to be the most common complication but obstruction became more common. The cumulative risk of pouchitis, fistula, and intestinal obstruction continued to rise after 10 years, whereas the other complications remained constant. The cumulative risk of developing a complication for group A and B patients are in Table 2. Group B patients had a significantly higher risk of the development of wound infection and anastomotic separa- Table 2 Estimated Cumulative Risk of Complications for the Two Groups Variable BMI <30 BMI 30 p value Pouchitis a 54.4 58.1 0.9 Obstruction a 26.7 22.3 0.02 Anastomotic stricture 23.7 17.2 0.1 Fistula a 11.4 13.4 0.3 Wound infection 8.1 18.8 <0.001 Pouch failure a 6 4.5 0.9 Pelvic sepsis 5.3 6.7 0.3 Hemorrhage 4.8 5.6 0.7 Any complication a 88 94.9 0.006 a Cumulative risk over 15 years of follow-up.

J Gastrointest Surg (2008) 12:668 674 671 Table 3 Daytime and Nighttime Frequency of Bowel Movements in the Two Groups Variable BMI <30 BMI 30 p value 1 year Day 5.7±2.2 6.6±5.2 0.06 Night 1.8±1.6 2.3±2.8 0.03 5 years Day 5.6±3.7 5.9±2.6 0.08 Night 1.7±1.7 1.8±1.4 0.12 10 years Day 5.3±2.3 5.8±2.7 0.15 Night 1.7±1.3 1.9±1.6 0.2 15 years Day 5.7±4.4 5.5±4.5 0.35 Night 4.8±5.2 1.9±1.1 0.19 Data are presented as the mean±sd. p<0.0125 (Bonferroni-corrected significance level). tion whereas group A patients had a higher rate of development of obstruction over time. Functional outcome Results relating to function of the pouch were assessed at 1, 5, 10, and 15 years of follow-up by the mean number of bowel movements during the day and night (Table 3), incontinence, pad usage during the day and at night (Table 4), and urgency. The mean number of bowel movements both during the day and at night was similar between groups at 1, 5, 10, and 15 years of follow-up. The proportion of patients using pads during the day and night and with urgency at 1, 5, 10, and 15 years of follow-up was also similar between groups. Overall, continence for the two groups over the duration of follow-up was hence similar. QOL All the components of CGQL and the overall CGQL score 1 year after surgery improved considerably from the baseline and remained high after 5, 10, and 15 years of follow-up for group B. A significant number of patients (97%) continued to remain satisfied with their operation after 15 years of follow-up and stated that having undergone the procedure, they would be willing to undergo Table 4 Daytime and Nighttime Pad Usage in the Different Groups Variable BMI <30, n (%) BMI 30, n (%) p value 1 year Day 109 (21.6) 20 (20.6) 0.68 Night 140 (28) 25 (26) 0.16 5 years Day 148 (17.7) 31 (20.4) 0.43 Night 185 (22.3) 38 (25) 0.46 10 years Day 119 (19) 19 (21.1) 0.64 Night 143 (23.1) 26 (28.6) 0.25 15 years Day 62 (21.1) 11 (25.6) 0.5 Night 75 (25.7) 10 (23.8) 0.79 Data are presented as the mean±sd. p<0.0125 (Bonferroni-corrected significance level). IPAA again if they were given the option. A significant proportion (97.9%) also continued to state their willingness to recommend the procedure to other patients in a situation similar to theirs (Table 5). The two groups continued to maintain a high QOL as determined by CGQL during the duration of follow-up. Group B patients had significantly lower CEL than group A patients at 5 and 10 years after surgery. However, there was no significant difference in the other components of CGQL and overall CGQL score. All the components of CGQL and the overall CGQL score were similar between groups at 1 and 15 years after surgery. Discussion Although the ileoanal pouch is an established technique for the treatment of ulcerative colitis and familial adenomatous polyposis and has been shown to be useful in patients with indeterminate colitis and carefully selected CD patients, there is little data in the literature looking at the role of the procedure in obese patients. 13 Obesity has previously been reported to lead to increased operating room time and resource utilization in general surgical operations. 14 There are also data supporting adverse outcomes after surgery in obese patients undergoing gynecologic and orthopedic operations. 15,16 Poor long-term function has also been Table 5 QOL in Groups A and B Variable BMI <30 BMI 30 p value Baseline QOL 6.8±2.1 6.9±2.5 0.8 QOH 7±2.2 7.3± 2.1 0.8 CEL 6.6±2.4 6±2.1 0.5 CGQL 0.7±0.2 0.7±0.2 0.8 1 year QOL 8.4±1.6 8.2±1.8 0.4 QOH 8.4±1.6 8.1±1.8 0.2 CEL 7.7±1.9 7.4±2 0.1 CGQL 0.8±0.2 0.8±0.2 0.2 5 years QOL 8.6±1.5 8.4±1.8 0.3 QOH 8.4±1.7 8.1±1.9 0.09 CEL 7.8±2 7.3±2 0.002* CGQL 0.8±0.2 0.8±0.2 0.02 10 years QOL 8.6±1.6 8.4±2 0.3 QOH 8.4±1.7 8.1±2 0.2 CEL 7.8±1.9 7.2±2.3 0.008* CGQL 0.8±0.2 0.8±0.2 0.03 15 years QOL 8.6±1.6 8.6±1.2 0.6 QOH 8.3±1.8 8±1.4 0.06 CEL 7.7±1.9 7.4±2.1 0.3 CGQL 0.8±0.2 0.8±0.1 0.2 Data are presented as the mean±sd. QOL: quality of life, QOH: quality of health, CEL: current energy level, CGQL: Cleveland Global Quality of Life *p<0.0125 (Bonferroni-corrected significance level)

672 J Gastrointest Surg (2008) 12:668 674 described after surgery for some other general surgical conditions. 17 A previous study that examined the impact of obesity on surgical outcomes after colectomy reported that the risk of complications may be worsened in patients undergoing left colectomy and proctectomy. 18 For patients undergoing IPAA, associated additional significant intraoperative technical challenges may be expected. In addition to difficulty with intraabdominal, pelvic, and perineal exposure, the bulky mesentery in obese patients may serve as a deterrent for the reach of the pouch to the pelvic floor. The creation of an ileostomy in obese patients is also often attendant with operative difficulties because of the presence of a foreshortened, bulky mesentery and a thick abdominal wall. BMI is a measure of an individual s weightinrelationto height and is calculated as weight in kilograms divided by the square of height in meters. The World Health Organization has adopted the weight classifications developed by the National Institutes of Health (NIH) that recommend the use of BMI >30 as a definition of obesity. We chose to evaluate outcomes in patients with obesity and hence selected patients with BMI 30. There is a dearth of information on the risk of pouch surgery, long-term complications, functional outcomes, and QOL in this select group of high-risk patients. A previous study compared outcomes after IPAA in 31 obese patients (BMI 30) with those for the same number of nonobese patients matched for age, gender, steroid use, and diagnosis. 13 This study reported higher perioperative morbidity in obese patients but the long-term functional outcome after restorative proctocolectomy was similar to that of the nonobese patients. The study, however, included a small number of patients matched to a control group of nonobese patients with a mean follow-up of 50.7 months. In contrast, our study evaluates outcomes in a large group of obese patients, the largest reported in the literature thus far, and compares them to all the nonobese patients included in the pouch database. Despite the expected difficulties with the formation of a stoma in obese patients, most patients in our series underwent a defunctioning stoma. The patients were found to have an acceptable risk of complications, and this risk was comparable to that expected for IPAA based on current reports. 19 21 The pouch failure rate over 15 years of followup was 4.5%. Thus, the long-term results of IPAA in the obese group are very encouraging and suggest that obesity should not be a deterrent to patients being offered the procedure. Studies have shown that QOL after IPAA is rated as excellent by patients with minimal deterioration in pouch function with time. 11 Although there was some deterioration in function with time, the function of the pouch in the obese patients remained acceptable as manifested in the high QOL. The mean number of daytime and nighttime bowel movements, urgency, daytime and nighttime pad usage, and incontinence remained acceptable over the duration of follow-up. The functional outcome was similar to that of reports in the literature based on studies examining outcomes for patients (obese and nonobese patients not separately examined) undergoing IPAA. 22,23 In our study, patients with BMI 30 had an appreciable increase in QOL from the baseline as measured by an elevation in CGQL. All the components of CGQL including QOL, QOH, and CEL, and the overall CGQL score were found to increase from the baseline value 1 year after surgery, continued to rise after 5 years, and continued to be sustained even after 15 years after surgery. Most patients said they would have the procedure again and would recommend the procedure to others. The percentage of patients with this response continued to increase with increasing duration of follow-up. We compared patients with BMI 30 with those <30 BMI to determine any differences in the preoperative and perioperative factors between the two groups of patients and evaluated whether the former group would have adverse outcomes when compared with the nonobese patients. Group B patients were significantly older than group A patients but both groups had comparable age, gender, diagnosis, and indication for surgery. However, group B patients had a significantly higher proportion of patients with associated comorbidity and on steroids and immunosuppressive medication, thus suggesting that these patients were sicker than group A patients. Despite similar indications for surgery and diagnosis in the two groups, a greater proportion of group B patients underwent a stapled anastomosis. This may be related to the fact that a handsewn anastomosis is technically more demanding in obese patients. As our preference is for a stapled anastomosis at this institution and as both groups had comparable diagnoses and indication for surgery, a handsewn anastomosis would be indicated when a stapled anastomosis failed because of technical reasons. Thus, it can be surmised that the incidence of intraoperative technical problems may have been lower in the obese group of patients when compared with the others despite the increased challenges. A previous study reported that a higher proportion of obese patients underwent mucosectomy, 13 although this difference did not reach statistical significance between groups in this study. The incidence of complications such as pouchitis, sepsis, hemorrhage, and anastomotic stricture was similar in group A and group B patients. Although group B patients had a higher incidence of immediate complications such as wound infection and anastomotic separation when compared with group A patients, the incidence of pouch failure over a long duration of follow-up was similar in the two

J Gastrointest Surg (2008) 12:668 674 673 groups. In contrast, group B patients had a significantly lower incidence of obstruction than group A patients. The increased risk of wound infection in obese patients has previously been described in general surgical operations. 8 10 A previous study on IPAA also noted a higher incidence of complications in obese patients. 13 Patients in the obese group had similar function as evaluated by the frequency of daytime and nighttime bowel movements, pad usage, urgency, and incontinence at 1, 5, 10, and 15 years of follow-up. Previous studies have demonstrated that IPAA patients have a good QOL after surgery. 24 26 We found that QOL as determined by QOL, QOH, CEL, and CGQL remained high in both groups after surgery. A significantly lower CEL was noted at 5 and 10 years after surgery in group B patients when compared with group A. However, the other components of CGQL and the overall CGQL score were comparable over the duration of follow-up and at the different time frames of comparison. By asking patients about their decision to have undergone IPAA and of their willingness to recommend the procedure to other patients in their situation at each followup, we gave them an opportunity to reevaluate their decision to undergo surgery. The response of patients at this time would be expected to take into account their QOL, functional results, complications, and freedom from illness. A high proportion of patients (97.9%) continued to state that they would undergo the procedure again and would recommend the procedure to other patients even after 15 years of follow-up. Restorative proctocolectomy in obese patients is associated with a significantly higher incidence of wound infection and anastomotic separation. The proportion of patients retaining a functional pouch is, however, high and is comparable to that of nonobese patients. Long-term functional outcome and QOL is acceptable and patients are happy with their decision to undergo the procedure. IPAA may hence be offered to patients with a BMI 30 after assessing the risks associated with the procedure. As they are more likely to suffer potentially serious complications than patients with BMI <30, when possible, postponing surgery until weight loss is achieved merits due consideration. References 1. Kohler LW, Pemberton JH, Hodge DO, Zinsmeister AR, Kelly KA. Long-term functional results and quality of life after ileal pouch-anal anastomosis and cholecystectomy. World J Surg 1992;16(6):1126 1131. discussion 1131 1132, Nov Dec. 2. Becker JM. Surgical management of inflammatory bowel disease. Curr Opin Gastroenterol 1993;9:600 615. 3. Wells AD, McMillan I, Price AB, Ritchie JK, Nicholls RJ. Natural history of indeterminate colitis. 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