Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transanal irrigation, antegrade enema.
- Who it may be relevant to
- Registry conditions: Low Anterior Resection Syndrome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial
Overview
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.
Interventions
- Other transanal irrigation
The enema is administered retrogradely via the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. the catheter is gently and slowly inserted 7-10 cm through the anus. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the - Other antegrade enema
The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. Using a disposable catheter, insert it about 20 cm. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000
Primary outcome measures
- low anterior resection syndrome score (LARS score) [Time frame: Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal]
Secondary outcome measures (3)
- bowel function [Time frame: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal]
- quality of life for rectal cancer patients [Time frame: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal]
- quality of sleep [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan — Chengdu, Sichuan
Identifiers
NCT: NCT06717854 · SCCHEC-02-2024-226