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Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Start date: Dec 20, 2024 to Mar 25, 2025
    • Secondary endpoints revised (3)
    v3
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are: 1. To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery 2. To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection. Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS. Participants will: 1. Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.
Trial Details
NCT Number NCT06717854
Lead Sponsor Sichuan Cancer Hospital and Research Institute
Conditions
(from sponsor)
Low Anterior Resection Syndrome
Related terms Low Anterior Resection Syndrome
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov