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.
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
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.
Parallel
Pelvic Floor Physiotherapy (PFR)
BehavioralIntervention: Participants will undergo a structured pelvic floor physiotherapy program for three months. The program includes: Eight Personal Sessions: Each session lasts 45 minutes. Frequency: Once a week for the first month (four sessions). Biweekly for the next two months (four sessions). Home Exercises: Participants will be guided on pelvic floor exercises to be performed at home throughout the three months.
Conventional group
BehavioralPatients completing three months post-low anterior resection (LAR) for rectal cancer or six weeks post-diversion ileostomy closure following LAR will be recruited to Conventional group after randomization. Recruited subjects in the conventional group recieves usual care following low anterior resection such as fluid intake, fiber intake, diet, toilet posture, life style advice etc
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.
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.
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.
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GEM Hospital & Research Center
Lead sponsor
JOGO Health Pvt Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
