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

NCT ID: NCT06717854

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-12-30

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.

Conditions

Low Anterior Resection Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

transanal irrigation

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Hui Yang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

China

Central Contacts

Hai Hu, M.D.

Role: CONTACT

Hu_hai2019@outlook.com

8613540662185

Facility Contacts

Hai Hu, M.D.

Role: primary

Hu_hai2019@outlook.com

8613540662185

Other Identifiers

SCCHEC-02-2024-226

Identifier Type: -

Identifier Source: org_study_id