Keeping the cecum clean: a randomized, prospective, placebo-controlled trial of loperamide as part of preparation for colonoscopy.

BACKGROUND: Coating of the cecum with sticky bile causes a problem with inspection of the mucosa during colonoscopy. PURPOSE: This study aimed to see whether 4 mg of loperamide taken after colonoscopy preparation would delay the passage of bile and improve the quality of cecal preparation. PATIENTS: Patients undergoing office colonoscopy were included. Patients with incomplete colonoscopies or right colectomy were excluded. STUDY DESIGN: This study was a prospective, randomized, double-blinded, and placebo-controlled trial. INTERVENTION: Either 2 placebo capsules or 2 loperamide capsules were taken after gut lavage, as soon as the passage of liquid stool ceased. Cecal photographs were scored in a blinded fashion. MAIN OUTCOME MEASURES: The primary outcomes measured were the quality of cecal preparation on a scale of 1 to 5 and overall preparation on a scale of 1 to 4. RESULTS: Ninety-eight patients took loperamide (50 men, 48 women) and 102 took placebo (57 men, 45 women). Mean ages of the loperamide group were: men, 61.9 ± 11.9 years, and women, 61.8 ± 10.0 years; and mean ages of the placebo group were: men, 62.5 ± 12.1 years, and women, 58.6 ± 9.8 years. Over 90% of patients used a polyethylene glycol-based preparation. Thirteen of 102 (12.7%) placebo cases had a dirty or coated cecum (score 4 or 5). In the loperamide group, this number was 2 of 98 (2.0%; p = 0.0041). Nineteen placebo cases (18.6%) had an overall fair/poor preparation in comparison with 9 of the loperamide group (9.2%; p = 0.0543). Days to first bowel movement were 2.4 ± 1.1 for loperamide and 2.5 ± 1.7 for placebo (p = 0.7224). Fifty-eight percent of loperamide patients had polyps, and 74% of these patients had multiple polyps; 67% of placebo patients had polyps, but only 54% of these patients had multiple polyps (vs loperamide, p = 0.0183). CONCLUSION: Judicious use of loperamide can significantly improve the quality of cecal preparation and may increase polyp yield.

Comparison of perineal operations with abdominal operations for full-thickness rectal prolapse.

BACKGROUND: We can divide surgery for rectal prolapse into two broad categories: abdominal and perineal. However, few studies compare the long-term outcomes and quality of life among operations for full-thickness rectal prolapse. The purpose of this study was to compare abdominal (AO) versus perineal (PO) procedures for the treatment of full-thickness rectal prolapse regarding recurrence rate, incontinence, constipation, and quality of life. METHODS: Records of 177 operations from 1995 to 2001 were reviewed retrospectively. A telephone survey was attempted for all. Seventy-five (42%) responded to the Cleveland Clinic Incontinence Score (CCIS), KESS Constipation Score (KESS-CS), and SF-36 Quality of Life Score. Appropriate statistical analysis was performed. RESULTS: For the 122 AO and 55 PO, there were no deaths. Mean follow-up was similar (PO 3.1 vs. AO 3.9 years; P = 0.306). As expected the PO patients were older (mean 69 vs. 55 years) and had higher ASA scores. Those undergoing PO had less procedural blood loss, operative time, hospital stay, and dietary restriction. The PO group also scored worse on the physical component of SF-36 (PO 33 vs. AO 39.6; P = 0.034). However, the rate of recurrent prolapse was significantly higher for the PO (PO 26.5% vs. AO 5.2%; P < 0.001). Complications, CCIS, KESS-CS, and SF-36 mental component were similar in both groups. CONCLUSIONS: In full-thickness rectal prolapse, elderly, sick patients are selected for a perineal operation. The morbidity, functional outcomes, and quality of life are acceptable. However, the high recurrence rates make the perineal operation a second-best choice for younger, healthy patients.

A comparative study of 2 sustained-release morphine preparations for pain in advanced cancer.

PURPOSE: Several sustained-release morphine (SRM) formulations are available internationally. This study compared 2 such products available in the United States, SR1 and SR2. PATIENTS AND METHODS: In an open-label study, patients with advanced cancer pain were randomized to receive SR1 or SR2 every 12 hours around-the-clock (ATC) for 5 days, with immediate release (IR) liquid morphine for rescue dosing (RD). Efficacy, safety, and patient acceptability were determined. RESULTS: A total of 32 patients were evaluable for efficacy and toxicity. Pain scores, RD dosage, RD frequency over 5 days, RD within 3 hours before and after the scheduled SRM, and 8 of the 11 evaluated side effects were higher in the SR1 group. At presumed morphine steady state (day 3), pain scores (P = .05), RD dosage (P = .07), RD frequency (P = .07), and number of RD +/-3 hours from scheduled SRM dose (P = .05) were consistently greater in the SR1 group (despite a higher median morphine dose in that group). There was a clinically important and directionally consistent trend that favored SR2, although not all were statistically significant. Patient preference favored SR2 (P < .05). Neither group had difficulty swallowing SR1 or SR2. CONCLUSIONS: This is the first study that directly compared two 12-hour SRM formulations. The data suggested, by multiple clinically important measures, that SR2 may provide superior analgesic efficacy and less toxicity compared to SR1. It also supports the concept that it cannot be assumed that different SR formulations of a given opioid are clinically equivalent. A larger study is needed to confirm our findings.

Ten-year outcome after anal sphincter repair for fecal incontinence.

PURPOSE: This study aimed to report at ten years on the results of the same cohort that had been studied at five years who had undergone an anal sphincter repair for fecal incontinence. METHODS: Patients studied at five years were contacted after ten years and asked to fill out the Fecal Incontinence Quality of Life Scale, the Fecal Incontinence Severity Index, and the Bristol Stool Form Scale. RESULTS: Thirty-one of 44 (71 percent) patients were contacted. Median follow-up time was 129 (range, 113 to 208) months. Median age at surgery was 44 (range, 22 to 80) years. No patients were fully continent at 129 months. Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life scores were correlated with the age at surgery. Older patients had lower Fecal Incontinence Quality of Life scores (P = 0.001), reflecting a lower quality of life, and a higher patient-rated Fecal Incontinence Severity Index score (P = 0.01) and a higher surgeon-rated Fecal Incontinence Severity Index score (P = 0.005), denoting more severe fecal incontinence. The Bristol Stool Form Scale, not utilized at 77 months, showed a correlation to patient-rated Fecal Incontinence Severity Index (P = 0.04) and surgeon-rated Fecal Incontinence Severity Index (P = 0.02). Fecal Incontinence Severity Index scores were significantly higher in women who had more than two vaginal births. CONCLUSION: Continence after overlapping sphincter repair deteriorates in the long term. Long-term outcome was worse for patients who were older at the time of surgery or those with two or more vaginal births. The Bristol Stool Form Scale score correlates with the severity of incontinence, and may be used to guide the management of the patient's symptoms.

The effect of colorectal surgery in female sexual function, body image, self-esteem and general health: a prospective study.

OBJECTIVE: To evaluate women's sexual function, self-esteem, body image, and health-related quality of life after colorectal surgery. SUMMARY BACKGROUND DATA: Current literature lacks prospective studies that evaluate female sexuality/quality of life after colorectal surgery using validated instruments. METHODS: Sexual function, self-esteem, body image, and general health of female patients undergoing colorectal surgery were evaluated preoperatively, at 6 and 12 months after surgery, using the Female Sexual Function Index, Rosenberg Self-Esteem scale, Body Image scale and SF-36, respectively. RESULTS: Ninety-three women with a mean age of 43.0 +/- 11.6 years old were enrolled in the study. Fifty-seven (61.3%) patients underwent pelvic and 36 (38.7%) underwent abdominal procedures. There was a significant deterioration in overall sexual function at 6 months after surgery, with a partial recovery at 12 months (P = 0.02). Self-esteem did not change significantly after surgery. Body image improved, with slight changes at 6 months and significant improvement at 12 months, compared with baseline (P = 0.05). Similarly, mental status improved over time with significant improvement at 12 months, with values superior than baseline (P = 0.007). Physical recovery was significantly better than baseline in the first 6 months after surgery with no significant further improvement between 6 and 12 months. Overall, there were no differences between patients who had abdominal procedures and those who underwent pelvic dissection, except that patients from the former group had faster physical recovery than patients in the latter (P = 0.031). When asked about the importance of discussing sexual issues, 81.4% of the woman stated it to be extremely or somewhat important. CONCLUSION: Surgical treatment of colorectal diseases leads to improvement in global quality of life. There is, however, a significant decline in sexual function postoperatively. Preoperative counseling is desired by most of the patients.

A randomized controlled trial comparing simultaneous intra-operative vs sequential prophylactic ureteric catheter insertion in re-operative and complicated colorectal surgery.

OBJECTIVES: Prophylactic insertion of ureteric stents aids intra-operative identification of ureters and may allow easier visualization of any direct ureteric injury. Traditionally, ureteric catheters are inserted sequentially, before starting the abdominal part of the operation. This study determines the safety and efficacy of simultaneous intra-operative ureteric catheter insertion during complicated and re-operative colorectal surgery. MATERIALS AND METHODS: After institutional review board (IRB) approval, 24 patients were randomized into two groups, sequential (SEQ) and simultaneous (SIM) depending upon the timing of stent placement relative to abdominal incision. Time taken from induction to abdominal incision (AIT), induction to peritoneal entry (PET), catheter insertion time (CIT), and urinary tract infection rates were recorded. Degree of difficulty for stent insertion was graded on a scale of 1-10. RESULT: Demographics were similar between groups. Mean AIT (22 +/- 4 vs 41 +/- 7; p = 0.0001) and mean PET (26 +/- 4.2 vs 44 +/- 7.6; p = 0.0001) were shorter in the SIM group. There was no significant difference in mean CIT in SIM and SEQ groups (17.9 +/- 4.9 vs 17.6 +/- 5.9 min, p = 0.8). The stents were unsuccessful bilaterally in one patient in the SEQ group and unilaterally in two other patients, one in each group. The median difficulty score for catheter insertion was 3 (1-10) and 2 (1-10), (p = 0.12), respectively, in SIM and SEQ groups. There were no ureteric injuries in either group. One patient in SIM developed a urinary tract infection. CONCLUSION: Simultaneous ureteric catheter insertion during abdominal procedures reduces operating times without a significant increase in morbidity. Furthermore, this permits a policy of selective stent insertion as required by the intra-abdominal findings after laparotomy.

Long-term outcome and quality of life after continent ileostomy.

INTRODUCTION: This study was designed to evaluate long-term outcomes for patients undergoing Kock continent ileostomy, identify factors associated with adverse outcomes, and compare changes in quality of life after removal of the reservoir. METHODS: The records of all patients (n = 330) undergoing continent ileostomy at the Cleveland Clinic Foundation between 1974 and 2001 were reviewed. Patient-related, intraoperative, and postoperative factors were evaluated as predictor variables of long-term pouch survival. Quality of life was evaluated using the continent ileostomy surgery follow-up questionnaire and the Cleveland Global Quality of Life scale (n = 216). These were compared between patients with continent ileostomy (n = 181) and patients who underwent removal of the continent ileostomy and conversion to an end stoma (n = 35). RESULTS: The median patient follow-up was 11 (range, 1-27) years. The median revision-free pouch interval was 14 (95 percent confidence interval, 11-17) months. The 10-year and 20-year pouch survival was 87 and 77 percent, respectively. Patients had an average of 3.7(range, 1-28) complications and 2.9 (range, 1-27) pouch revisions during follow-up. On multivariate analysis, Crohn's disease (hazard ratio = 4.5), female gender (hazard ratio = 2.4), fistula development (hazard ratio = 3), and body mass index (hazard ratio = 2.4 per 5 unit increase) were independent predictors of pouch failure. Quality of life measurements for patients with a continent ileostomy were higher on all scales in comparison with patients who had the Kock reservoir and then reverted to a Brooke ileostomy. CONCLUSIONS: Despite the associated morbidity with continent ileostomy surgery, long-term results and quality of life were encouraging. Continent ileostomy may be offered as an attractive long-term option to select patients whose only alternative is an end ileostomy.

Vaginal delivery after ileal pouch-anal anastomosis: a word of caution.

PURPOSE: This study was designed to evaluate the impact of childbirth on anal sphincter integrity and function, functional outcome, and quality of life in females with restorative proctocolectomy and ileal pouch-anal anastomosis. METHODS: The patients who had at least one live birth after ileal pouch-anal anastomosis were asked to return for a comprehensive assessment. They were asked to complete the following questionnaires: the Short Form-36, Cleveland Global Quality of Life scale, American Society of Colorectal Surgeons fecal incontinence severity index, and time trade-off method. Additionally, anal sphincter integrity (endosonography) and manometric pressures were measured by a medical physician blinded to the delivery technique. Anal sphincter physiology also was evaluated with electromyography and pudendal nerve function by nerve terminal motor latency technique. RESULTS: Of 110 eligible females who had at least one live birth after ileal pouch-anal anastomosis, 57 participated in the study by returning for clinical evaluation to the clinic and 25 others by returning the quality of life and functional outcome questionnaires. Patients were classified into two groups: patients who had only cesarean section delivery after ileal pouch-anal anastomosis (n = 62) and patients who had at least one vaginal delivery after ileal pouch-anal anastomosis (n = 20). The mean follow-up from the date of the most recent delivery was 4.9 years. The vaginal delivery group had significantly higher incidence of an anterior sphincter defect by anal endosonography (50 percent) vs. cesarean section delivery group (13 percent; P = 0.012). The mean squeeze anal pressure was significantly higher in the patients who had only cesarean section delivery (150 mmHg) after restorative proctocolectomy than patients who had at least one vaginal delivery (120 mmHg) after restorative proctocolectomy (P = 0.049). Quality of life evaluated by time trade-off method also was significantly better in the cesarean section delivery group (1) vs. vaginal delivery group (0.9; P < 0.001). CONCLUSIONS: The risk of the sphincter injury and quality of life measured by time trade-off method are significantly worse after vaginal delivery compared with cesarean section in patients with ileal pouch-anal anastomosis. In the short-term, this does not seem to substantially influence pouch function or quality of life; however, the long-term effects remain unknown, thus obstetric concern may not be the only factor dictating the type of delivery in this group of patients. A planned cesarean section may eliminate these potential and factual concerns in ileal pouch-anal anastomosis patients.

Incontinence after a lateral internal sphincterotomy: are we underestimating it?

PURPOSE: This study was designed to assess the long-term outcomes and quality of life of patients who have undergone a sphincterotomy for chronic anal fissure. METHODS: The medical records of patients who underwent this operation between 1992 and 2001 were reviewed. A questionnaire was mailed to assess their current status, along with the Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index surveys. RESULTS: A total of 298 patients were identified (158 males; 53 percent; mean age, 46.9 years; mean follow-up, 4.3 years). Postal survey response was 62 percent. Recurrence of the fissure occurred in 17 patients (5.6 percent) of whom 9 (52 percent) were females. Significant factors that resulted in recurrence were initial sphincterotomy performed in the office and local anesthesia (P < 0.001). When comparing office records and response to the postal survey, significantly more patients had flatal incontinence than that recorded in their medical records (P < 0.001). Twenty-nine percent of females who had a vaginal delivery recorded problems with incontinence to flatus (P = 0.04). Temporary incontinence was reported in 31 percent of patients and persistent incontinence to gas occurred in 30 percent. Stool incontinence was not a significant finding. The overall quality-of-life scores were in the normal range, whereas the median Fecal Incontinence Severity Index score was 12. CONCLUSIONS: Recurrence after lateral internal sphincterotomy may be higher after local anesthesia or office procedure. Females who have two or more previous vaginal deliveries should be warned about possible flatal incontinence. Long-term flatal incontinence that is not reported to the caregiver may occur in up to one-third of patients and could be permanent.

Comprehensive evaluation of inflammatory and noninflammatory sequelae of ileal pouch-anal anastomoses.

BACKGROUND AND AIMS: Ileal pouch-anal anastomosis (IPAA) improves quality of life (QOL) for ulcerative colitis patients who require surgery. Crohn's disease (CD) of the pouch, pouchitis, cuffitis, and irritable pouch syndrome (IPS) have an adverse impact on physical and psychological well-being, which can compromise the gain in QOL after the surgery. Their clinical, endoscopic, and histologic features have not been fully characterized. The aim of this study was to compare demographic, clinical, endoscopic, and histologic features between CD of the pouch, pouchitis, cuffitis, IPS, and normal pouches. METHODS We enrolled 124 patients: normal pouches (N = 26), CD of the pouch (N = 23), pouchitis (N = 22), cuffitis (N = 21), and IPS (N = 32). Symptomatology, endoscopy, histology, and the Cleveland Global QOL and the Irritable Bowel Syndrome-QOL scores were compared among the groups. RESULTS: Univariate analysis of demographic and clinical data showed a possible association between NSAID use and pouchitis, extraintestinal manifestation and cuffitis, and antidepressant use and IPS. There were no differences in the Pouchitis Disease Activity Index symptom scores between the disease groups, with an exception of bleeding, which occurred almost exclusively in cuffitis. Endoscopy was useful in discriminating between CD of the pouch, pouchitis, cuffitis, and normal pouches or IPS. Patients with diseased IPAA had worse QOL scores. CONCLUSIONS: Symptoms largely overlapped among the disease groups of IPAA. Endoscopy is valuable for diagnosis. Inflammatory or noninflammatory sequelae of IPAA adversely affected patients' QOL.

Fertility is reduced after restorative proctocolectomy with ileal pouch anal anastomosis: a study of 300 patients.

BACKGROUND: Restorative proctocolectomy and ileal pouch anal anastomosis (RP/IPAA) has become the gold standard surgical therapy for the majority of patients with mucosal ulcerative colitis and familial adenomatous polyposis. The aims of this study were to evaluate the fertility rates before and after RP/IPAA, to compare them with the reproductive data of the general United States population, and to determine surgical parameters that might influence subsequent fertility. METHODS: Three hundred women of reproductive age who underwent RP/IPAA between 1983 and 2001 completed a mailed questionnaire regarding their reproductive function before and after the procedure. Additional information was obtained from the pelvic pouch database. The reproductive information was compared to age-matched historical control subjects from the United States general population. The associations between changes in fertility and surgical parameters were also investigated. RESULTS: The median (25th, 75th percentile) age at surgery was 28 (24, 33) years. Out of 300 women, 206 attempted to conceive. Before operation, 48 (38%) of 127 patients were unsuccessful after 1 year of unprotected intercourse, whereas after operation, 76 (56%) of 135 patients were unsuccessful. This infertility rate was higher after operation than before (P <.001). For the subgroup of 56 women who tried to get pregnant both before and after operation, the infertility rate was higher after operation than before (69% vs 46%; P=.005). Also, a higher percentage of these patients who had an intraoperative transfusion were infertile after operation compared to patients who did not have an intraoperative transfusion (54% vs 21%; P=.023). CONCLUSIONS: There was an increase in the infertility rate after RP/IPAA. Intraoperative blood transfusion had a negative impact on the fertility rate after operation in patients who tried to conceive both before and after RP/IPAA.

Treatment of rectal cuff inflammation (cuffitis) in patients with ulcerative colitis following restorative proctocolectomy and ileal pouch-anal anastomosis.

BACKGROUND: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the treatment of choice in the majority of patients with ulcerative colitis (UC) who require surgery. To ease the construction of the IPAA and improve functional outcome by minimizing sphincter related stretch injury, a stapling technique is being commonly used in the pouch-anal anastomosis. Despite its advantages, the procedure normally leaves a 1-2 cm of anal transitional zone or rectal cuff, which is susceptible to recurrence of residual UC or cuffitis. Cuffitis can cause symptoms mimicking pouchitis. AIM: To conduct an open-labeled trial of topical mesalamine in patients with cuffitis. METHODS: We treated 14 consecutive patients with cuffitis by giving mesalamine suppositories 500 mg b.i.d. (mean 3.2 months, range 1-9 months). The Cuffitis Activity Index (adapted from the Pouchitis Disease Activity Index) scores and improvement in symptoms of bloody bowel movements and arthralgias were measured as primary and secondary outcomes. RESULTS: All patients had surgery for medically refractory UC. There were significant reductions in the total Cuffitis Activity Index scores after the therapy (11.93 +/- 3.17 vs 6.21 +/- 3.19, p < 0.001). Symptom (3.24 +/- 1.28 vs 1.79 +/- 1.31), endoscopy (3.14 +/- 1.29 vs 1.00 +/- 1.52), and histology (4.93 +/- 1.77 vs 3.57 +/- 1.39) scores each were significantly reduced (p < 0.05). Ninety-two percent of patients with bloody bowel movements and 70% of patients with arthralgias improved after the therapy. No systemic or topical adverse effects were reported. CONCLUSION: Topical mesalamine appears well tolerated and effective in treating patients with cuffitis, with improvement in symptom as well as endoscopic and histologic inflammation.

Dysplasia of the anal transitional zone after ileal pouch-anal anastomosis: results of prospective evaluation after a minimum of ten years.

PURPOSE: Stapling of the ileal pouch-anal anastomosis with preservation of the anal transitional zone remains controversial because of concerns about the potential risk of dysplasia and cancer. The natural history and optimal treatment of anal transitional zone dysplasia ten or more years after surgery are unknown. This study establishes the risk of dysplasia in the anal transitional zone and the outcome of a conservative management policy for anal transitional zone dysplasia, with a minimum of ten years' follow-up after ileal pouch-anal anastomosis. METHODS: A total of 289 patients undergoing anal transitional zone-sparing stapled ileal pouch-anal anastomosis for inflammatory bowel disease between 1986 and 1990 were studied. Patients undergoing anal transitional zone-sparing ileal pouch-anal anastomosis who were studied with serial anal transitional zone biopsies for at least ten years postoperatively were included (n = 178). Median follow-up was 130 (range, 120-157) months. RESULTS: Anal transitional zone dysplasia developed in 8 patients 4 to 123 (median, 9) months after surgery. There was no association with gender, age, preoperative disease duration, or extent of colitis, but the risk of anal transitional zone dysplasia was significantly associated with cancer or dysplasia as a preoperative diagnosis or in the proctocolectomy specimen. Dysplasia was high grade in two patients and low grade in six. Two patients with low-grade dysplasia on two or more occasions after detection of low-grade dysplasia underwent completion mucosectomy and perineal pouch advancement with neo-ileal pouch-anal anastomosis. One patient with high-grade dysplasia on two occasions was to undergo completion mucosectomy, but this was not technically feasible. Partial mucosectomy with vigorous anal transitional zone biopsy was performed with close postoperative surveillance. Biopsies were negative for dysplasia. The second recently diagnosed patient with high-grade dysplasia underwent examination under anesthesia with negative anal transitional zone biopsies and will be kept under close surveillance. No cancer in the anal transitional zone was found during the study period. The 4 other patients with low-grade dysplasia on 1 or 2 occasions were treated expectantly and have been dysplasia free for a median of 119 (range, 103-133) months. CONCLUSIONS: Anal transitional zone dysplasia after stapled ileal pouch-anal anastomosis is infrequent and is usually self-limiting. Anal transitional zone preservation did not lead to the development of cancer in the anal transitional zone with a minimum of ten years of follow-up. Long-term surveillance is recommended to monitor dysplasia. If repeat biopsy confirms persistent dysplasia, mucosectomy with perineal pouch advancement and neo-ileal pouch-anal anastomosis is recommended.