Dataset Information

Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol.

ABSTRACT:

Introduction

Radical surgery after a total mesorectal excision (TME) for rectal cancer often results in a significant decrease in the patient's quality of life, due to functional problems such as bowel, urinary and sexual dysfunction. The effect of pelvic floor muscle training (PFMT) on these symptoms has been scarcely investigated. We hypothesise that the proportion of successful patients will be significantly higher in the intervention group, receiving 12 weeks of PFMT, compared with the control group without treatment. The primary outcome of this trial is the severity of bowel symptoms, measured through the Low Anterior Resection Syndrome questionnaire, 4 months after TME or stoma closure. Secondary outcomes are related to other bowel and urinary symptoms, sexual function, physical activity and quality of life.

Methods and analysis

This research protocol describes a multicentre single blind prospective, randomised controlled trial. Since January 2017, patients treated for rectal cancer (n=120) are recruited after TME in three Belgian centres. One month following surgery or, in case of a temporary ileostomy, 1 month after stoma closure, patients are randomly assigned to the intervention group (n=60) or to the control group (n=60). The assessments concern the preoperative period and 1, 4, 6, 12 and 24 months postoperatively.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki. Ethics approval was granted by the local Ethical Committee of the University Hospitals Leuven (s59761) and positive advice from the others centres has been obtained. Dissemination of the results will be accomplished via guidelines and (non-)scientific literature for professionals as well as organisation of patient symposia.

Trial registration number

NTR6383.

SUBMITTER: Asnong A

PROVIDER: S-EPMC7831707 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol.

Asnong Anne A D'Hoore André A Van Kampen Marijke M Devoogdt Nele N De Groef An A Sterckx Kim K Lemkens Hilde H Wolthuis Albert A Van Molhem Yves Y Van Geluwe Bart B Debrun Lynn L Geraerts Inge I

BMJ open 20210122 1

<h4>Introduction</h4>Radical surgery after a total mesorectal excision (TME) for rectal cancer often results in a significant decrease in the patient's quality of life, due to functional problems such as bowel, urinary and sexual dysfunction. The effect of pelvic floor muscle training (PFMT) on these symptoms has been scarcely investigated. We hypothesise that the proportion of successful patients will be significantly higher in the intervention group, receiving 12 weeks of PFMT, compared with t ...[more]

PMID: 33483444

Similar Datasets

Project description:Interventions: Patients not recruited into COALA-1 will be included into COALA-2. At centers where physiotherapists are unavailable, all patients will be directly recruited into COALA-2. Electronic phone application based based physiotherapy intervention where patients download an electronic application on their phone with a preset pelvic floor exercise regimen and built in reminders to perform these exercises. Patients will be asked to complete these exercises three times a day for at least 12 weeks. This will begin at least 1 week before ileostomy reversal, but ideally 4-6 weeks prior to ileostomy reversal if they are able to be recruited in time. Adherence will be monitored through in app function which records exercise engagement and duration. Information about lifestyle modification, theory behind pelvic floor exercises, and how to perform these exercises will be available on the application in written, pictorial and video format. An example of the exercises prescribed in would be as follows: These exercises are a set prescription of repetitions Initially, muscle identification exercises - Position: Sitting forward in a chair, with knees and legs apart - Exercise: Squeeze pelvic floor and identify pelvic floor lift Rest 4 seconds, then repeat 3-4 times This will be repeated 3 times/day Then, an ongoing regime of this exercise will be prescribed as follows: Exercise 1- Hold 5-10sec, rest5-10sec ( pending on patient’s ability)/5reps increase to 10 reps/3xday Exercise 2- Hold/Rest/ 10reps increase to 20 reps/3xday Follow exercise 3, 4 and daily application as above The duration of these exercises is variable as this depends on the repetitions rather than a specific time. Primary outcome(s): Incidence of low anterior resection syndrome via validated Low Anterior Resection Score (LARS) developed and validated by Emmertson et al in 2012 Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21. PMID: 22504191.[1, 6 and 12 months after closure of loop ileostomy] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: Pelvic floor muscle training will be delivered via 6 fortnightly, 1 hour, face to face one on one physiotherapy appointments over 12 weeks (at least 4 weeks before and at least 6 weeks after ileostomy closure following low anterior resection) using a standardised approach to each appointment to deliver an individualised treatment plan for each patient. Each session will consist of a targeted history to determine symptoms, education about lifestyle modifications, assessment of Pelvic floor muscles via anal palpation with/ or Transabdominal ultrasound (where available), education and review of exercises. Patients will then be asked to perform exercises daily for 3 times per day and this will be logged in an exercise diary. The exercises and emphasis will be tailored to a patient’s symptoms and ability. An example of the exercises prescribed in would be as follows: These exercises are a set prescription of repetitions Initially, muscle identification exercises - Position: Sitting forward in a chair, with knees and legs apart - Exercise: Squeeze pelvic floor and identify pelvic floor lift Rest 4 seconds, then repeat 3-4 times This will be repeated 3 times/day Then, an ongoing regime of this exercise will be prescribed as follows: Exercise 1- Hold 5-10sec, rest5-10sec ( pending on patient’s ability)/5reps increase to 10 reps/3xday Exercise 2- Hold/Rest/ 10reps increase to 20 reps/3xday Follow exercise 3, 4 and daily application as above The duration of these exercises is variable as this depends on the repetitions rather than a specific time. Primary outcome(s): Incidence of low anterior resection syndrome via validated Low Anterior Resection Score (LARS) developed and validated by Emmertson et al in 2012 Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21. PMID: 22504191.[1, 6 and 12 months after closure of loop ileostomy] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: The pelvic floor intervention for rectal cancer patients will be delivered in two stages: (1) pre-rehabilitation and (2) rehabilitation. There is actual recommendation to provide rehabilitation before surgeries in order to prepare patients to improve their functional outcomes. The content of pre-rehabilitation and rehabilitation will include pelvic floor exercises and other techniques aiming to recover pelvic floor maximal function after the surgery and to avoid low anterior resection syndrome (LARS) symptoms. The pelvic floor intervention, including all stages and techniques, will be provided by a physical therapist with a postgraduation study on pelvic floor treatment with experience in treating rectal cancer patients. This professional will be trained by researchers on the study protocol. The intervention will take place in a private room of Hospital del Salvador. Stage 1: Pelvic Floor Pre-rehabilitation will be delivered in one session of approximately 40 minutes with physiotherapist educating on the correct contraction of pelvic floor, teaching pelvic floor muscle exercises, and performing capacitive and sensory training with rectal balloon. Health education will include: the most adequate positioning to evacuate, self-care strategies such as diet with high fiber and low fat, reduce spicy and stimulating food (artificial sweeteners, tea, cola drinks and chocolates), and bowel habits (possibility to have increased urgency to defecate after meal or physical activities). A booklet was designed for this study with these instructions and exercises will be provided to the patients as well as an audio that will be sent to their cell phones using Whatsapp application. A mobile number with a whatsapp account will be maintained by the pelvic floor therapist to se Primary outcome(s): Mean score of bowel symptoms For the main outcome we will use the questionnaire ICIQ-B and the LARS score.[(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT) (T2) Immediatelly after pelvic floor rehabilitation (T0) baseline];Mean scores of anorectal function. High resolution anorectal manometry will be used to assess the maximal resting pressure, maximal squeeze pressure, rectal capacity (maximal tolerable volume), and rectal sensitivity (initial sensation threshold). We will use high resolution anorectal manometry with a 24-channels water-perfused catheter (Multiplex, Alacer, Biomedica, Sao Paulo, Brazil). This equipment is a low-cost water perfused system which showed to be adequate for clinical use (Silva et al, 2018; Viebig et al, 2018). According to a previous study we will define as effective an improvement of > 15% in the anorectal manometry parameters. This test will be performed by a trained physician. Silva RMB, Herbella FAM, Gualberto D. Normative values for a new wáter-perfused high resolution manometry system. Arq Gastroenterol 2018; 55:30-34 Viebig RG, Franco JTY, Araujo SV, Gualberto D. Water-perfused high-resolution anorectal manometry (hram-wp): the first brazilian study. Arq. Gastroenterol. 2018;55(Suppl 1):41-46. [(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT) (T2) Immediatelly after pelvic floor rehabilitation (T1) before rehabilitation - standardized at approximately 6 months of ostomy use after rectal cancer surgery (T0) baseline] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:BackgroundRectal cancer is commonly treated by chemoradiation therapy, followed by the low anterior resection anal sphincter-preserving surgery, with a temporary protecting ileostomy. After reversal of the stoma a condition known as low anterior resection syndrome (LARS) can occur characterized by a combination of symptoms such as urgent bowel movements, lack of control over bowel movements, and difficulty fully emptying the bowels. These symptoms have a significant negative impact on the quality of life for individuals who have survived the cancer. Currently, there is limited available data regarding the presence, risk factors, and effects of treatment for these symptoms during long-term follow-up.AimsTo evaluate long term outcomes of low anterior resection surgery and its correlation to baseline anorectal manometry (ARM) parameters and physiotherapy with anorectal biofeedback (BF) treatment.MethodsOne hundred fifteen patients (74 males, age 63 ± 11) who underwent low anterior resection surgery for rectal cancer were included in the study. Following surgery, patients were managed by surgical and oncologic team, with more symptomatic LARS patients referred for further evaluation and treatment by gastroenterologists. At follow up, patients were contacted and offered participation in a long term follow up by answering symptom severity and quality of life (QOL) questionnaires.Results80 (70%) patients agreed to participate in the long term follow up study (median 4 years from stoma reversal, range 1-8). Mean time from surgery to stoma closure was 6 ± 4 months. At long term follow up, mean LARS score was 30 (SD 11), with 55 (69%) patients classified as major LARS (score > 30). Presence of major LARS was associated with longer time from surgery to stoma reversal (6.8 vs. 4.8 months; p = 0.03) and with adjuvant chemotherapy (38% vs. 8%; p = 0.01). Patients initially referred for ARM and BF were more likely to suffer from major LARS at long term follow up (64% vs. 16%, p < 0.001). In the subgroup of patients who underwent perioperative ARM (n = 36), higher maximal squeeze pressure, higher maximal incremental squeeze pressure and higher rectal pressure on push were all associated with better long-term outcomes of QOL parameters (p < 0.05 for all). 21(54%) of patients referred to ARM were treated with BF, but long term outcomes for these patients were not different from those who did not perform BF.ConclusionsA significant number of patients continue to experience severe symptoms and a decline in their quality of life even 4 years after undergoing low anterior resection surgery. Prolonged time until stoma reversal and adjuvant chemotherapy emerged as the primary risk factors for a negative prognosis. It is important to note that referring patients for anorectal physiology testing alone tended to predict poorer long-term outcomes, indicating the presence of selection bias. However, certain measurable manometric parameters could potentially aid in identifying patients who are at a higher risk of experiencing unfavorable functional outcomes. There is a critical need to enhance current treatment options for this patient group.

Project description:UnlabelledWHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Stress urinary incontinence (SUI) affects 10-35% of women, and it is sometimes very distressful. Pelvic floor exercises are the first line of treatment, but access barriers or embarrassment may prevent women from seeking help. There is a need for new, simple, and effective ways to deliver treatment. Management of SUI without face-to-face contact is possible, and Internet-based treatment is a new, promising treatment alternative.ObjectiveTo compare two treatment programmes for stress urinary incontinence (SUI) without face-to-face contact: one Internet-based and one sent by post.Patients and methodsRandomised, controlled trial conducted in Sweden 2009-2011. Computer-generated block-randomisation, allocation by independent administrator. No 'blinding'. The study included 250 community-dwelling women aged 18-70 years, with SUI ≥1 time/week. Consecutive online recruitment. The women had 3 months of either; (i) An Internet-based treatment programme (124 women), including e-mail support and cognitive behavioural therapy assignments or (ii) A treatment programme sent by post (126). Both programmes focused mainly on pelvic floor muscle training.Primary outcomessymptom-score (International Consultation on Incontinence Questionnaire Short Form, ICIQ-UI SF) and condition-specific quality of life (ICIQ-Lower Urinary Tract Symptoms Quality of Life, ICIQ-LUTSQoL).Secondary outcomes(i) Patient Global Impression of Improvement, (ii) Incontinence aids, (iii) Patient satisfaction, (iv) Health-specific QoL (EQ5D-Visual Analogue Scale), and (v) Incontinence episode frequency. Follow-up after 4 months via self-assessed postal questionnaires.ResultsIn all, 12% (30 women) were lost to follow-up. Intention-to-treat analysis showed highly significant improvements (P < 0.001) with large effect sizes (>0.8) with both interventions, but there were no significant differences between groups in primary outcomes. The mean (sd) changes in symptom-score were: Internet 3.4 (3.4), Postal 2.9 (3.1) (P = 0.27). The mean (sd) changes in condition-specific QoL were: Internet 4.8 (6.1), Postal 4.6 (6.7) (P = 0.52). Compared with the postal-group, more participants in the Internet-group perceived they were much or very much improved (40.9% (43/105) vs 26.5% (30/113), P = 0.01), reported reduced usage of incontinence aids (59.5% (47/79) vs 41.4% (34/82), P = 0.02) and were satisfied with the treatment programme (84.8% (89/105) vs 62.9% (71/113), P < 0.001). Health-specific QoL improved in the Internet-group (mean change 3.7 (10.9), P = 0.001), but not in the postal-group (1.9 (13.0), P = 0.13). Overall, 69.8% (120/172) of participants reported complete lack of leakage or reduced number of leakage episodes by >50%.ConclusionsConcerning primary outcomes, treatment effects were similar between groups whereas for secondary outcomes the Internet-based treatment was more effective. Internet-based treatment for SUI is a new, promising treatment alternative.

Dataset Information

Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets