Tracy L. Hull

Long-Term Functional Outcome and Quality of Life After Stapled Restorative Proctocolectomy

OBJECTIVE To evaluate prospectively long-term quality of life and functional outcome after restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis, and to evaluate and validate a novel quality-of-life indicator in this group of patients. SUMMARY BACKGROUND DATA Restorative proctocolectomy with ileal pouch-anal anastomosis is now the preferred option when total proctocolectomy is required for ulcerative colitis or familial adenomatous polyposis, but long-term data on functional outcome and quality of life after the procedure are lacking. METHODS Patients (n = 977) who underwent RPC with stapled anastomosis for colitis or polyposis coli and who were followed for > or =12 months were included. Quality of life, fecal incontinence, and satisfaction with surgery were prospectively evaluated by structured interview or questionnaire for 1 to 12 years after surgery (median 5.0). Quality of life was scored using the Cleveland Global Quality of Life (CGQL) instrument (Fazio Score). This is a novel score developed over the past 15 years by the senior author. Quality of life was also evaluated in a subgroup of patients with the Short Form 36 (SF-36). The CGQL was validated by determining its reliability, responsiveness, and validity as well as its correlation with the SF-36 score. RESULTS Postoperative quality of life as measured by SF-36 was excellent and compared well with published norms for the general U.S. population. The CGQL was found to be reliable, responsive, and valid, and there was a high correlation with the SF-36 scores. Using the CGQL, quality of life was shown to increase after the first 2 years after surgery, and there was no deterioration thereafter. The prevalence of perfect continence increased from 75.5% before surgery to 82.4% after surgery, and although this deteriorated somewhat >2 years after surgery, it was no worse than preoperative values. Ninety-eight percent of patients would recommend the surgery to others. CONCLUSIONS Long-term quality of life after ileal pouch surgery is excellent and the level of continence is satisfactory. This surgery is an excellent long-term option in patients requiring total proctocolectomy. The CGQL is a simple, valid, and reliable measure of quality of life after pelvic pouch surgery and may well be applicable in many other clinical conditions.

The Standardization of Terminology for Researchers in Female Pelvic Floor Disorders

Abstract: The lack of standardized terminology in pelvic floor disorders (pelvic organ prolapse, urinary incontinence, and fecal incontinence) is a major obstacle to performing and interpreting research. The National Institutes of Health convened the Terminology Workshop for Researchers in Female Pelvic Floor Disorders to: (1) agree on standard terms for defining conditions and outcomes; (2) make recommendations for minimum data collection for research; and (3) identify high priority issues for future research. Pelvic organ prolapse was defined by physical examination staging using the International Continence Society system. Stress urinary incontinence was defined by symptoms and testing; ‘cure’ was defined as no stress incontinence symptoms, negative testing, and no new problems due to intervention. Overactive bladder was defined as urinary frequency and urgency, with and without urge incontinence. Detrusor instability was defined by cystometry. For all urinary symptoms, defining ‘improvement’ after intervention was identified as a high priority. For fecal incontinence, more research is needed before recommendations can be made. A standard terminology for research on pelvic floor disorders is presented and areas of high priority for future research are identified.

Outcomes of Primary Repair of Anorectal and Rectovaginal Fistulas Using the Endorectal Advancement Flap

AbstractPURPOSE: The endorectal advancement flap is a surgical procedure used in the treatment of anorectal and rectovaginal fistulas. There is a wide range of success rates published in the literature. This study was undertaken to examine the success rate of primary endorectal advancement flap in our own institution. We attempted to identify factors that influence the rate of healing. METHODS: A retrospective review was performed on 105 patients (43 males) who underwent their first endorectal advancement flap at our institution between January 1, 1994, and June 30, 1999. Ninety-nine patients were available for follow-up. Sixty-two patients had anorectal and 37 had rectovaginal fistulas. The causes of fistula included cryptoglandular (48 patients), Crohn’s disease (44), obstetric injury (5), trauma (1), and other (1). RESULTS: The median follow-up was 17.1 (range, 0.4–66.9) months. The median age was 42 (range, 16–78) years. Recurrence was seen in 36 patients (36.4 percent); thus, the primary rate of healing was 63.6 percent. Factors that were associated with higher rates of success were increased age (P = 0.011), greater body surface area (P = 0.012), history of incision and drainage of a perianal abscess preceding advancement flap (P = 0.010), previous placement of a seton drain (P = 0.025), and short duration of fistula (P = 0.003). Factors that negatively influenced the healing rate of the flap were the diagnoses of Crohn’s disease (P = 0.027) and rectovaginal fistula (P = 0.002). Length of hospitalization, discharge on oral antibiotics, and the presence of a diverting stoma did not influence the rate of healing. Prednisone was associated with a distinct trend toward failure, with none of the patients on high-dose prednisone (greater than 20 mg/day) having achieved long-term healing. No fistulas recurred after a period of 15 months. CONCLUSION: The endorectal advancement flap is an effective method of repair for both anorectal and rectovaginal fistulas, even though the success rate may not be as optimistic as in some other published studies. Patient selection is imperative, realizing that a higher rate of failure may be present in Crohn’s disease and rectovaginal fistulas. Control of sepsis before endorectal advancement flap with drainage of a perianal abscess and/or seton placement, whenever possible, is indicated.

Effect of resection margins on the recurrence of Crohn's disease in the small bowel: A randomized controlled trial

OBJECTIVE The authors assess the effect of surgical margin width on recurrence rates after intestinal resection of Crohns Disease (CD). BACKGROUND The optimal width of margins when resecting DC of the small bowel is controversial. Most studies have been retrospective and have had conflicting results. METHODS Patients undergoing ileocolic resection for CD (N = 152) were randomly assigned to two groups in which the proximal line of resection was 2 cm (limited resection) or 12 cm (extended resection) from the macroscopically involved area. Patients also were classified by whether the margin of resection was microscopically normal (category 1), contained nonspecific changes (category 2), were suggestive but not diagnostic for CD (category 3), or were diagnostic for CD (category 4). Recurrence was defined as reoperation for recurrent preanastomotic disease. RESULTS Data were collected on 131 patients. Median follow-up time was 55.7 months. Disease recurred in 29 patients: 25% of patients in the limited resection group and 18% of patients in the extended resection group. In the 90 patients in category 1 with normal tissue, recurrence occurred in 16, whereas in the 41 patients with some degree of microscopic involvement, recurrence occurred in 13. Recurrence rates were 36% in category 2, 39% in category 3, and 21% in category 4. No group differences were statistically at the 0.01 level. CONCLUSION Recurrence of CD is unaffected by the width of the margin of resection from macroscopically involved bowel. Recurrence rates also do not increase when microscopic CD is present at the resection margins. Therefore, extensive resection margins are unnecessary.

Long-term outcome of overlapping anal sphincter repair.

AbstractPURPOSE: This study reviews the long-term outcome of overlapping anal sphincteroplasty for acquired anal incontinence. METHODS: Seventy-one consecutive patients underwent overlapping sphincteroplasty from 1989 to 1996. Current degree of continence and associated quality of life were determined by telephone interview using the Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life Scale, as validated by The American Society of Colon and Rectal Surgeons. Both the patient-rated and the surgeon-rated Fecal Incontinence Severity Index scores were recorded. Demographic and perioperative data were obtained from patient charts. RESULTS: Forty-nine (69 percent) of the 71 patients, with a median age of 38.5 (range, 22–80) years, could be contacted at a median of 69 (range, 48–141) months after sphincter repair. Four patients were diverted at the time of follow-up. Twenty-four (54 percent) patients were incontinent to liquid or solid stool, and only six patients (14 percent) were totally continent. Fifteen patients (34 percent) had the best possible Fecal Incontinence Quality of Life score of 16. The median patient-rated and surgeon-rated Fecal Incontinence Severity Index scores were 20 (range, 0–61) and 20 (range, 0–57), respectively. The patient-rated score correlated to the surgeon-rated score (r = 0.98, P < 0.001) and the Fecal Incontinence Quality of Life score (r = 0.64, P < 0.001). CONCLUSION: Years after sphincter repair surgery more than half of the patients are incontinent to liquid or solid stool. The American Society of Colon and Rectal Surgeons-validated Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life scores are useful and complementary tools for evaluation of fecal incontinence.

Sacral nerve stimulation for fecal incontinence: Results of a 120-patient prospective multicenter study

Background:Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Methods:Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing ≥50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that ≥50% of subjects would achieve therapeutic success, defined as ≥50% reduction of incontinent episodes per week at 12 months compared with baseline. Results:A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2–69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%–90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusion:Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.

Prospective, Age-Related Analysis of Surgical Results, Functional Outcome, and Quality of Life After Ileal Pouch-Anal Anastomosis

Objective To evaluate how age affects functional outcome and quality of life after ileal pouch anal anastomosis (IPAA). Summary Background Data Because of the limited number of older patients undergoing IPAA, it has been difficult to assess functional outcome and quality of life stratified by age. Methods IPAA was performed in 1895 patients. Patients were stratified by age into <45 (n = 1410), 46–55 (n = 289), 56–65 (n = 154), and more than 65 years (n = 42). Outcome was assessed prospectively. Results are presented at 1, 3, 5, and 10 years after surgery. Results Patients were followed for 4.6 ± 3.7 years (maximum, 17 years). Pouch failure occurred in 4.1% (pouch excision or permanent diversion). Incontinence and night time seepage were more common in older patients. There were minor differences in the quality of life, health, energy and happiness between age groups, with a slight benefit for those under 45 years. Fourteen percent or fewer patients experienced social, sexual or work restrictions. Overall, 96% of patients were happy to have undergone their surgery, and 98% recommended it to others. Although the respective figures were 89% and 96% in the over-65 age group, the difference was not significant. Conclusions These data provide a unique assessment of outcome after IPAA at multiple time points. Although functional outcome after IPAA is not as good in older patients, appropriate case selection confers acceptable function and quality of life to patients of all ages.

Long-term analysis of the use of transanal rectal advancement flaps for complicated anorectal/vaginal fistulas

Transanal rectal advancement flap (TRAF) is a surgical option in the management of rectovaginal and other complicated fistulas involving the anorectum. Most reported series have a short follow-up. PURPOSE: This study was undertaken to determine the long-term success, safely, applicability, and factors affecting recurrence in patients managed with TRAF, including patients with Crohns disease. METHODS/MATERIALS: Retrospective analysis of all patients undergoing endorectal advancement flaps at a single institution between 1988 and 1993 was performed. One hundred one patients were identified (70 percent female; 30 percent male). Included were 52 patients with rectovaginal, 46 with anal perineal, and 3 with rectourethral fistulas. Causes were obstetric injury in 13 patients, Crohns disease in 47, cryptoglandular in 19, mucosal ulcerative colitis in 7, and surgical trauma or undefined causes in 15 patients. RESULTS: No mortality occurred. Median follow-up was 31 (range, 1–79 months). Immediate failure (within one week of the repair) was seen in 6 percent of patients. Statistically (tP<0.001) higher recurrence rates were observed in patients who had undergone previous repairs. Mean hospital stay was four days. Overall recurrence was seen in 29 patients (29 percent). Seventy-five percent of all recurrences occurred within the first 15 months; however, recurrence was noted for up to 55 months after repair. Etiology of fistula, use of constipating medications, antibiotic use, and most importantly associated Crohns disease did not statistically affect recurrence rates. Failure rate was only influenced by previous number of repairs. CONCLUSION: TRAF is a safe technique for managing complicated anorectal and rectovaginal fistulas, including patients with Crohns disease. Long-term follow-up is essential to accurately report recurrence rates.

Pan-colonic decrease in interstitial cells of Cajal in patients with slow transit constipation

Background: Interstitial cells of Cajal (ICC) are required for normal intestinal motility. ICC are found throughout the human colon and are decreased in the sigmoid colon of patients with slow transit constipation. Aims: The aims of this study were to determine the normal distribution of ICC within the human colon and to determine if ICC are decreased throughout the colon in slow transit constipation. Patients: The caecum, ascending, transverse, and sigmoid colons from six patients with slow transit constipation and colonic tissue from patients with resected colon cancer were used for this study. Methods: ICC cells were identified with a polyclonal antibody to c-Kit, serial 0.5 μm sections were obtained by confocal microscopy, and three dimensional software was employed to reconstruct the entire thickness of the colonic muscularis propria and submucosa. Results: ICC were located within both the longitudinal and circular muscle layers. Two networks of ICC were identified, one in the myenteric plexus region and another, less defined network, in the submucosal border. Caecum, ascending colon, transverse colon, and sigmoid colon displayed similar ICC volumes. ICC volume was significantly lower in the slow transit constipation patients across all colonic regions. Conclusions: The data suggest that ICC distribution is relatively uniform throughout the human colon and that decreased ICC volume is pan-colonic in idiopathic slow transit constipation.

A randomized multicenter trial to compare long-term functional outcome, quality of life, and complications of surgical procedures for low rectal cancers.

Introduction:Colonic pouches have been used for 20 years to provide reservoir function after reconstructive proctectomy for rectal cancer. More recently coloplasty has been advocated as an alternative to a colonic pouch. However there have been no long-term randomized, controlled trials to compare functional outcomes of coloplasty, colonic J-Pouch (JP), or a straight anastomosis (SA) after the treatment of low rectal cancer. Aim:To compare the complications, long-term functional outcome, and quality of life (QOL) of patients undergoing a coloplasty, JP, or an SA in reconstruction of the lower gastrointestinal tract after proctectomy for low rectal cancer. Methods:A multicenter study enrolled patients with low rectal cancer, who were randomized intraoperatively to coloplasty (CP-1) or SA if JP was not feasible, or JP or coloplasty (CP-2) if a JP was feasible. Patients were followed for 24 months with SF-36 surveys to evaluate the QOL. Bowel function was measured quantitatively and using Fecal Incontinence Severity Index (FISI). Urinary function and sexual function were also assessed. Results:Three hundred sixty-four patients were randomized. All patients were evaluated for complications and recurrence. Mean age was 60 ±12 years, 71% were male. Twenty-three (7.4%) died within 24 months of surgery. No significant difference was observed in the complications among the 4 groups. Two hundred ninety-seven of 364 were evaluated for functional outcome at 24 months. There was no difference in bowel function between the CP-1 and SA groups. JP patients had fewer bowel movements, less clustering, used fewer pads and had a lower FISI than the CP-2 group. Other parameters were not statistically different. QOL scores at 24 months were similar for each of the 4 groups. Conclusions:In patients undergoing a restorative resection for low rectal cancer, a colonic JP offers significant advantages in function over an SA or a coloplasty. In patients who cannot have a pouch, coloplasty seems not to improve the bowel function of patients over that with an SA.