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

NCT06717854 | Not Yet Recruiting

• 1 other identifier: SCCHEC-02-2024-226
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 3.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.
4. 4.Keep a diary of their symptoms.

Conditions

Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

• low anterior resection syndrome score (LARS score)

  Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal

Secondary Outcomes (3)

• bowel function

  before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal

• quality of life for rectal cancer patients

  before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal

• 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

Other Outcomes (3)

• 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

Study Arms (3)

standard of care

NO INTERVENTION

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.

antegrade enema

EXPERIMENTAL

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.

retrograde enema

EXPERIMENTAL

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

Interventions

transanal irrigation OTHER

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.

retrograde enema

antegrade enema OTHER

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 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (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

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hai Hu, M.D.

CONTACT

8613540662185; Hu_hai2019@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 5, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 30, 2025

Record last verified: 2024-11

Locations

CN (1)