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

NCT07082699 | Not Yet Recruiting

• 1 other identifier: IIT2024153
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Success rate of ileostomy reversal

  Two months after the last enema

• low anterior resection syndrome score (LARS score)

  The LARS score consists of five components and the total score, ranging from 0 to 42. Severity levels are categorized as follows: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points).

  Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.

Secondary Outcomes (3)

• quality of sleep

  Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.

• bowel function

  one month, two months, three months, and six months after stoma closure.

• cancer patients' quality of life

  one month, two months, three months, and six months after stoma closure.

Other Outcomes (3)

• The psychosocial adjustment level of patients with enterostomy

  Evaluate one day before starting enemas and one month after enemas before performing stoma closure.

• The Stoma-Specific Quality of Life

  Evaluate one day before starting enemas and one month after enemas before performing stoma closure.

• Observation chart for anal excretion and irritation symptoms during ostomy (self-made)

  Evaluate one day before starting enemas and one month after enemas before performing stoma closure

Study Arms (3)

standard of care

NO INTERVENTION

antegrade enema

EXPERIMENTAL

Other: antegrade enema

retrograde enema

EXPERIMENTAL

Other: retrograde enema

Interventions

antegrade enema 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.

antegrade enema

retrograde enema 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.

retrograde enema

Eligibility Criteria

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

You may qualify if:

• According to the NCCN guidelines for the pathological diagnosis of rectal cancer, the patient has primary rectal adenocarcinoma;
• Age ≥ 18 years;
• Previously underwent rectal resection with prophylactic ileostomy via laparoscopy, robotics, or open surgery;
• Expected to undergo ileostomy reversal surgery within 1-2 months;
• Possesses normal cognitive and communication abilities;
• Voluntarily participates in this study and has signed an informed consent form.

You may not qualify if:

• American Society of Anesthesiologists (ASA) classification III or higher;
• Concurrent inflammatory bowel disease, Crohn's disease, or other intestinal diseases;
• Mental disorders, long-term use of psychiatric drugs;
• Contraindications to enemas.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

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

Study Design

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

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 24, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07