Long-term functional outcome and quality of life after stapled restorative proctocolectomy

Abstract

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.

Figure 1. Sample Cleveland Global Quality of Life (CGQL) form. The patient is asked to score each of the three items in the right-hand column. In this case, the patient scored 9, 10, and 7 for the quality of life, quality of health, and energy level, respectively. These scores were added and the total divided by 30 to give a final score of 0.867 in this case.

Figure 2. Overall Cleveland Global Quality of Life (CGQL) score and its three components (quality of life, energy level, and quality of health) for the periods 0 to 2 years, 2 to 5 years, 5 to 8 years, and >8 years after surgery. The overall CGQL score is scored on a scale of 0 to 1; each item is scored on a scale of 0 to 10. Each point represents a mean score; the black bars represent the 95% confidence intervals. For the overall CGQL and for each of its three component items, the scores significantly increased >2 years after surgery. *p < 0.05 vs. 0 to 2 years (analysis of variance with Dunnett’s test for multiple comparisons).

Figure 3. Scores for individual items of the SF-36 for 163 patients randomly selected from the study cohort. Scores are transformed and expressed on a scale of 0 to 100. Mean patient scores are shown by the shaded bars; standard deviations are shown by the error bars. Norms for the mean values for each item of the SF-36 for the general U.S. population are shown by the heavy black line. For both scales, higher scores represent a better quality of life. It is apparent that there is no difference between the scores of patients after pelvic pouch surgery and the general U.S. population for any of the eight items of the SF-36.

Figure 4. Percentage of patients with diurnal (□) or nocturnal (▪) seepage and/or diurnal (▵) or nocturnal (▴) pad usage during the four time periods studied after surgery. There were no significant changes in the incidence of seepage or pad usage with time after surgery.

Figure 5. Quality of life as measured by the Cleveland Global Quality of Life (CGQL) in patients with (A) incontinence, (B) work restriction, (C) social restriction, and (D) sexual restriction. Open squares represent CGQL scores in patients with incontinence or work, social, or sexual restrictions; closed squares represent CGQL scores in patients without these complaints. Values are mean scores, and the error bars represent the standard errors of the means. Incontinence and work, social, or sexual restrictions all result in a significantly lower CGQL at each time point studied. *p < 0.001; #p < 0.05 (analysis of variance).