The effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.
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ABSTRACT:
DISEASE(S): Rectal Cancer, Bowel Symptoms (fecal Incontinence, Urgency, Frequency, Fragmented Defecation, Soiling), Low Anterior Resection Syndrome
PROVIDER: 20608 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Interventions: The intervention is general rehabilitation plus pelvic floor muscle training program. The general rehabilitation will consist of a multidisciplinary education and exercise program, which will be provided as group sessions twice weekly for 8 weeks . Each session will last approximately one hour. The education component will include advice about nutrition, exercise, fatigue management and coping with stress and will be provided in a group format. Information will be delivered by a range of clinicians (physiotherapists, occupational therapists, psychologists, and dieticians). The exercise component will include an exercise training program supervised by a physiotherapist. The pelvic floor muscle training program will consist of physiotherapy-supervised pelvic floor muscle training sessions and bladder and bowel function advice over 12 sessions, twice weekly for 6 weeks. The training program will use a combination of 7 individual and 5 group sessions. Biofeedback will be used to facilitate pelvic floor muscle function. The training sessions will be approximately one hour long. The duration of intervention is eight weeks. To encourage adherence to the intervention protocols, telephone calls from a physiotherapist and a self report diary to record training adherence will be provided.
Primary outcome(s): Pelvic floor symptoms as assessed using the Australian Pelvic Floor Questionnaire and the International Consultation on Incontinence Questionnaire Bowel module[at baseline, immediately post-intervention, and at 6, 12, 24, and 60 months following baseline]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel
| 2460284 | ecrin-mdr-crc
Project description:Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies showed that pelvic floor muscle and external sphincter muscle training after stoma closure could improve the severity of incontinence and other fecal symptoms, but there is no study about the effects of pelvic floor muscle exercise intervention before stoma closure. We are wondering would the symptom of fecal incontinence recover sooner and better if we give the pelvic floor muscle exercise intervention before the stoma closure. This article aims at comparing the effects of pelvic floor muscle training before stoma closure on fecal incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure (post-intervention group), and we hypothesise that the severity of fecal incontinence will improve sooner and better in pre-intervention group.
| 2241840 | ecrin-mdr-crc
Project description:Interventions: Experimental group:Biofeedback electrical stimulation therapy +Kegel pelvic floor muscle functional exercise;Control group:Kegel pelvic floor muscle functional exercise
Primary outcome(s): Low anterior resection syndrome score;Quality of life score
Study Design: Parallel
| 37700 | ecrin-mdr-crc
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
| 2471038 | ecrin-mdr-crc
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
| 73485 | ecrin-mdr-crc
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
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