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

University of Electronic Science and Technology of China (UESTC)

Status: Not yet enrolling

Conditions: LARS - Low Anterior Resection Syndrome

Treatments: Other: retrograde enema; Other: antegrade enema

Study type: Interventional

Funder types: Other

Identifiers

NCT07082699

IIT2024153

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

standard of care

No Intervention group

antegrade enema

Experimental group

Treatment:

Other: antegrade enema

retrograde enema

Experimental group

Treatment:

Other: retrograde enema