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

Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Other: transanal irrigation; Other: antegrade enema

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hai Hu, M.D.; Phone Number: 8613540662185; Email: Hu_hai2019@outlook.com

Study Locations

• China
  • Chengdu, Sichuan, China
    • 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
    • Contact: Hai Hu, M.D.; Phone Number: 8613540662185; Email: Hu_hai2019@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard of care; The standard of care (SOC) was implemented following low anterior resection, which included the distribution of pamphlets and instructional videos to patients and their caregivers.
Experimental: antegrade enema; Participants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered through the distal end of the ileocecal stoma, directed towards the anus.	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. 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 choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.
Experimental: retrograde enema; Participants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered retrogradely via the anus.	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 choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Ostomy Adjustment Inventory-20 (OAI-20)	1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively
A quality of life questionnaire for people with an ostomy (Stoma-QoL)	1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively
Anal drainage and irritation during ileostomy (self-made)	1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Colonic Diseases; Low Anterior Resection Syndrome; Syndrome
• Other Study ID Numbers: SCCHEC-02-2024-226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No