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Feasibility trial of pelvic floor rehabilitation for bowel function issues after colorectal cancer surgery.

ABSTRACT: Interventions: Name: Pelvic floor rehabilitation program Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting. Intervention: A 15 minutes of education session will be provided at the commencement of the program at first week. Participants will be provided education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.The educational information and home exercise pamphlet is specifically designed for this study. Each participant will be assessed on their anorectal physiology by a colorectal surgeon and pelvic floor physiotherapist. Patient reported outcomes on bladder, bowel, sexual function and quality of life will be examined with questionnaires before and after the intervention. The intervention is a 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strengthening with use of transperineal ultrasound for visual biofeedback, anorectal sensory and coordination retraining using rectal balloon catheter biofeedback. Visual feedback will be provided via the application of a transperineal ultrasound. The patient will be able to visualise the pelvic floor muscle activity on the screen du Primary outcome(s): Adherence to pelvic floor rehabilitation program.Proportion with >80% attendance of supervised sessions. >80% of completion for weekly home exercises. This will be assessed by an attendance log and home exercise diary completion. [Post intervention program (12 weeks)] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Bowel Cancer,Physical Medicine / Rehabilitation-other Physical Medicine / Rehabilitation,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Bowel Dysfunction

PROVIDER: 2471038 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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:Interventions: A specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with 6 months no-adjuvant androgen deprivation therapy and men NOT receiving (ADT) prior to beginning radiation therapy. Androgen Deprivation Therapy dose will be standardiesd to Lucrin ( leuprorelin) 22.5 mgs intramuscularly 3 monthly. The intervention will be delivered one on one with physiotherapist. The protocol will be tailored to men’s measured pelvic floor muscle function and adherence to the program will be encouraged using motivational interviewing principles. Men receiving radiation therapy alone will meet with physiotherapist for review at all follow-up points which are : immediately radiation therapy completed ,at 1 and 3 months after radiation therapy . Ongoing contact with the physiotherapist will be undertaken using men’s preferred method-text/phone/email. All men in the intervention group will receive a copy of the DVD - pelvic floor exercises for men that was produced by the chief investigator for the Prostate Cancer Foundation of Australia. Men receiving ADT will need to exercise for 6 months prior to their RT . These men will also have adherence encouraged as above. Exercises will be tailored to baseline so men on ADT will need to visit the physiotherapist fortnightly for reassessment and progression. Exercise will need to be performed 3 times daily but the number of repetition each time exercise is undertaken will be tailored to individually to suit the baseline function of men’s measured pelvic floor muscle function. The exercise sets will be the number of contractions that can be repeate Primary outcome(s): Lower urinary tract symptoms : incontinence, urgency, frequency, nocturia etcetera validated instrument ICSMLUTS SF Lower bowel symptoms evaluated using validated instrument ICSMLUTS Bowel[Baseline for all men: Immediately following radiation therapy 3 months following radiation therapy 6 months following radiation therapy Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy usually 6 months after beginning androgen deprivation therapy. Thereafter for all men: Immediately following radiation therapy 3 months after Radiation therapy 6 months after Radiation therapy];Erectile dysfunction using a validated instrument IIEFQuality of Life validated instrument MYMOP2[Baseline for all men Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy usually 6 months after beginning androgen deprivation therapy.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

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Feasibility trial of pelvic floor rehabilitation for bowel function issues after colorectal cancer surgery.

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