Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Co… (NCT06524362) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial
India77 participantsStarted 2024-08
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: Adults aged 18 years or older.
* Surgical Procedure: Have undergone Low Anterior Resection (LAR) for rectal cancer.
* Cognitive Ability: Capable of understanding and completing the questionnaires effectively
Exclusion Criteria:
* Medical History: History of proctitis, ulcerative colitis, or Crohn's disease.
* Surgical Extent: Extensive resection (beyond Total Mesorectal Excision - TME) for
* locally advanced (T4) tumors, patients undergoing APR.
* Surgical Complications: History of anastomotic leakage.
* Recent Physiotherapy: History of invasive physiotherapy within the past 6 months.
* Mental or Physical Inabilities: Inability to undergo Pelvic Floor Rehabilitation due to mental or physical limitations
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
WEXNER INCONTINENCE SCORE
Timeframe: 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.