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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan Cancer Hospital and Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

Based on the NCCN guidelines for the pathological diagnosis of rectal cancer, patients are identified as having Primary Rectal Adenocarcinoma.

≥18 years.

For the first time, anterior rectal dissection combined with prophylactic ileostomy was performed using laparoscopic, robotic, and open techniques.

The patient exhibits normal cognitive and expressive abilities.

Disqualifiers

American Society of Anesthesiologists (ASA) Class III or higher.

A combination of other intestinal conditions, including inflammatory bowel disease and Crohn's disease.

Mental disorders and prolonged use of psychotropic medications.

The presence of contraindications to enema administration.

Trial design

Treatments tested in this trial

  • transanal irrigation
  • antegrade enema

Treatment groups

72 Participants
are divided into 3 treatment groups

Locations

1
Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Afffliated Cancer Hospital of University of Electronic Science and Technology of China Chengdu, Sichuan China

Sponsors and collaborators

Sichuan Cancer Hospital and Research Institute

Lead sponsor