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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGEM Hospital & Research Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pelvic Floor Physiotherapy (PFR)
  • Conventional group

Treatment groups

77 Participants
are divided into 2 treatment groups

Sponsors and collaborators

GEM Hospital & Research Center

Lead sponsor

JOGO Health Pvt Ltd

Collaborator