Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial
NCT Number: NCT06524362
Acronym: PERECARE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rectal Cancer|Rectum Neoplasm|Rectal Neoplasms|Rectal Adenocarcinoma|Low Anterior Resection Syndrome|Fecal Incontinence|Bowel Dysfunction
Interventions: BEHAVIORAL: Pelvic Floor Physiotherapy (PFR)|BEHAVIORAL: Conventional group
Sponsor: GEM Hospital & Research Center
Collaborators: JOGO Health Pvt Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 77
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2026-03
Locations: GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India

Summary:
Study Purpose:

This study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care.

Background:

Rectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2)

Current Knowledge:

Advances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery.

Past studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5)

Need for the Study:

There is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most.

Study Design:

This study is a randomized controlled trial that will:

* Compare PFR to usual care in patients after LAR surgery.
* Focus on bowel control and quality of life.
* Provide detailed insights to improve aftercare for rectal cancer patients.

Primary Outcome Measures: WEXNER INCONTINENCE SCORE, The Wexner Incontinence Score assesses fecal incontinence severity using patient-reported symptoms. Scores range from 0 (no incontinence) to 20 (severe incontinence), with higher scores indicating worse outcomes. Patients evaluate bowel control, leakage frequency, and lifestyle impacts, providing crucial data for treatment evaluation and comparison in clinical trials., Baseline score 6 weeks post-low anterior resection (LAR) or 6 weeks post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 18 weeks post-LAR or post-ileostomy closure.
Secondary Outcome Measures: Low Anterior Resection Syndrome score (LARS), The LARS Score measures bowel dysfunction following low anterior resection surgery, with scores ranging from 0 to 42. Higher scores indicate more severe symptoms such as bowel movement frequency, urgency, and incontinence. This patient-reported outcome assesses the impact on daily life, guiding treatment strategies and evaluating post-surgical outcomes in clinical trials., Baseline score 6 weeks post-low anterior resection (LAR) or 6 weeks post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 18weeks post-LAR or 18 weeks post-ileostomy closure.|Quality of life measure QORTC CR 29, The EORTC CR 29 assesses colorectal cancer-specific symptoms and treatment effects. Scores range from 0 to 100 per domain. Higher scores signify greater symptom burden or impact. Patients provide insights on bowel symptoms, urinary frequency, and emotional well-being, crucial for treatment assessment., Baseline score 6 weeks post-low anterior resection (LAR) or post-ileostomy closure. Post-intervention scores at 3 months post-start of pelvic floor physiotherapy for PFR group and 6 months post-LAR or 18 weeks post-ileostomy closure.