The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal

NCT ID: NCT07082699

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-20
• Study Completion Date: 2026-12-30

Brief Summary

Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation dysfunction after surgery, such as frequent bowel movements, urgent bowel movements, and faecal incontinence, known as low anterior resection syndrome (LARS). This can lead to a decline in quality of life after surgery and even partial loss of social functioning.

Conditions

LARS - Low Anterior Resection Syndrome

Study Design

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

Study Groups

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

antegrade enema

Group Type: EXPERIMENTAL

antegrade enema

Intervention Type: OTHER

Introduce saline at a flow rate of 40 ml/minute through the distal end of the ileostomy. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.

retrograde enema

Group Type: EXPERIMENTAL

retrograde enema

Intervention Type: OTHER

Introduce saline at a flow rate of 40 ml/minute through the anus. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.

Interventions

antegrade enema

Introduce saline at a flow rate of 40 ml/minute through the distal end of the ileostomy. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.

Intervention Type: OTHER

retrograde enema

Introduce saline at a flow rate of 40 ml/minute through the anus. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. According to the NCCN guidelines for the pathological diagnosis of rectal cancer, the patient has primary rectal adenocarcinoma;

2. Age ≥ 18 years;

3. Previously underwent rectal resection with prophylactic ileostomy via laparoscopy, robotics, or open surgery;

4. Expected to undergo ileostomy reversal surgery within 1-2 months;

5. Possesses normal cognitive and communication abilities;

6. Voluntarily participates in this study and has signed an informed consent form.

Exclusion Criteria

1. American Society of Anesthesiologists (ASA) classification III or higher;

2. Concurrent inflammatory bowel disease, Crohn's disease, or other intestinal diseases;

3. Mental disorders, long-term use of psychiatric drugs;

4. Contraindications to enemas.

• 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

Other Identifiers

IIT2024153

Identifier Type: -

Identifier Source: org_study_id