Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial

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.

Conditions

• Rectal Cancer
• Rectum Neoplasm
• Rectal Neoplasms
• Rectal Adenocarcinoma
• Low Anterior Resection Syndrome
• Fecal Incontinence
• Bowel Dysfunction

Interventions

BEHAVIORAL

Pelvic Floor Physiotherapy (PFR)

Intervention: 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.

BEHAVIORAL

Conventional group

Patients 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

Sponsors & Collaborators

• JOGO Health Pvt Ltd

  collaborator UNKNOWN

• GEM Hospital & Research Center

  lead OTHER

Principal Investigators

• Harshavardhana H P, MS DrNB (IP) · GEM Coimbatore

• RAJAPANDIAN S, DNB FRCS(Ed) · GEM Coimbatore

• PALANIVELU C, MS Mch FRCS · GEM Coimbatore

• HARISH KAKKILAYA, MS FACRSI · GEM Coimbatore

• SHANKAR B, MS DrNB FRCS · GEM Coimbatore

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-31

Primary Completion

2025-12-31

Completion

2026-03-31

Countries

• India

Study Locations