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

Not Applicable

Not yet recruiting

• Conditions: Low Anterior Resection Syndrome

• Registration Number: NCT06717854
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-30
• Study First Submitted QC: 2024-11-30
• Study First Posted: 2024-12-05
• Study Start: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 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.
• Informed consent was obtained for voluntary participation in the study.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
low anterior resection syndrome score (LARS score)	Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal

Secondary Outcome Measures

Name	Time	Method
bowel function	before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal	Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI)
quality of life for rectal cancer patients	before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal	quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 )
quality of sleep	before anterior rectal resection, before starting enemas 1 month postoperatively, 2 months, 3-4 months postoperatively; 1 month, 2 months, 3 months, 6 months after stoma reduction	Pittsburgh Quality Index (PSQI)

Trial Locations

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