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

Active, not recruiting

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

• Registration Number: NCT06601985
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-03-11
• Study Completion: 2025-04-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LARS score	From 1 month postoperatively to 12 months postoperatively	The LARS scale has five questions with a total score of 42. A score of 0-20 lacks diagnostic value for LARS, while a score of 21-29 indicates mild LARS and a score above 29 indicates major LARS.
FIQL	From 1 month postoperatively to 12 months postoperatively	The FIQL is a specific quality-of-life assessment scale applicable to the symptoms of colorectal cancer patients. It comprises 29 items, which are divided into four dimensions: lifestyle (10 items), coping/behavior restriction(9 items), depression/self-perception (7 items), and embarrassment (3 items).
Vaizey score	From 1 month postoperatively to 12 months postoperatively	The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.
Wexner score	From 1 month postoperatively to 12 months postoperatively	The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.

Secondary Outcome Measures

Name	Time	Method
Surgical complications	From 1 month postoperatively to 12 months postoperatively	Records post-operative anastomotic fistula, infection, bleeding, etc.

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital, Yanchang Road, Jing'an District, Shanghai, China; 🇨🇳 Shanghai, jingan, China