Clinical trial NCT06717854: Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial
Official title: Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Anterior Resection Syndrome
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: low anterior resection syndrome score (LARS score)
timeFrame: Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal
Secondary outcomes:
measure: bowel function
timeFrame: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
measure: quality of life for rectal cancer patients
timeFrame: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
measure: quality of sleep
timeFrame: 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
Other outcomes:
measure: Ostomy Adjustment Inventory-20 (OAI-20)
timeFrame: 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively
measure: A quality of life questionnaire for people with an ostomy (Stoma-QoL)
timeFrame: 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively
measure: Anal drainage and irritation during ileostomy (self-made)
timeFrame: 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively
Locations:
city: Chengdu, Sichuan
country: China
facility: 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
Study officials:
References: