Exploring the Effect of Colonic J-pouch in Anorectal Preservation Surgery for Ultra-low Rectal Cancer.

Tongji University

Status: Active, not recruiting

Conditions: Leakage, Anastomotic; Faecal Incontinence; Faecal Incontinence with Faecal Urgency; Rectum Cancer; Low Anterior Resection Syndrome

Treatments: Procedure: direct anastomosis; Procedure: J-pouch anastomosis

Study type: Observational

Funder types: Other

Identifiers

NCT06601985

24K30

Details and patient eligibility

About

The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour <5 cm from the anus or <3 cm from the dentate line, and treated with anus-preserving surgery;
2. No distant metastasis;
3. Age >18 years old;
4. Voluntary enrollment in the study and signing of an informed consent.

Exclusion criteria

1. A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4);
2. preoperative anal stenosis and anal nonfunction;
3. temporary stoma diversion.

Trial design

154 participants in 2 patient groups

J-pouch anastomosis group

Description:

Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch.

Treatment:

Procedure: J-pouch anastomosis

direct anastomosis group

Description:

Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis.

Treatment:

Procedure: direct anastomosis