Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)

Abstract

Background: After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50-80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment. Methods: The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes. Discussion: The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial.

Management guidelines for low anterior resection syndrome – the MANUEL project

“…Although surgeons worldwide are informed about LARS by societies, congresses and the scientific literature, there are still large gaps in knowledge about the treatment of LARS. A limited number of randomized controlled trials for LARS, mainly carried out by surgeons, are available [75,80–82] emphasizing the lack of sound evidence. The recommendation for the present guidance is therefore partly based on expert opinion.…”

Trajectories of Health-Related Quality of Life and Psychological Distress in Patients with Colorectal Cancer; a Population-Based Study.

“…psychologists and physical therapists) [19]. For instance, early results demonstrated that cognitive behavioural therapy reduced levels of distress in patients with CRC [42], and for a selection of (rectal cancer) patients, pelvic floor rehabilitation might provide relief in LARS-like symptoms [43].…”

“…The percentages of the patients with major LARS did not diminish over time, which is why an improved focus on early screening of LARS-like complaints is necessary to identify patients in need and provide the necessary supportive care. Early results of the FORCE trial showed promising results of protocolised pelvic floor rehabilitation in selective patients with rectal cancer suffering of LARS [43]. Besides that, medication (laxatives/loperamide) or rectal irrigation could provide relief of symptoms.…”

Pelvic Floor Rehabilitation After Rectal Cancer Surgery

“…24 Seeing that a withdrawal/replacement rate of 50% was anticipated, [12][13][14][15][16][17] 128 patients were included. 18 Primary analysis was done in the intention-to-treat population, supplemented by a per-protocol analysis, including patients who participated in PFR without serious protocol deviations and controls who did not participate in any form of PFR during follow-up. The mean change in Wexner scores was compared between groups by analysis of covariance.…”

“…A preoperative measurement (M1) with the same questionnaires as used continuously through the study administered before surgery reduced inclusion rates to such an extent that it had to be removed from the study protocol. 18 Randomization took place after completion of M2. Subsequently, patients either continued with usual care without PFR or participated in a standardized PFR program for 3 months, after which the primary endpoint (M3) analysis was done (Fig.…”