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: 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

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

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