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

NCT06601985 | Active Not Recruiting

• 1 other identifier: 24K30
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• LARS score

  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.

  From 1 month postoperatively to 12 months postoperatively

• FIQL

  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).

  From 1 month postoperatively to 12 months postoperatively

• Vaizey score

  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.

  From 1 month postoperatively to 12 months postoperatively

• Wexner score

  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.

  From 1 month postoperatively to 12 months postoperatively

Secondary Outcomes (1)

• Surgical complications

  From 1 month postoperatively to 12 months postoperatively

Study Arms (2)

J-pouch anastomosis group

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

Procedure: J-pouch anastomosis

direct anastomosis group

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

Procedure: direct anastomosis

Interventions

J-pouch anastomosis PROCEDURE

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

J-pouch anastomosis group

direct anastomosis PROCEDURE

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

direct anastomosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study population is the patients who diagnosed as ultra-low rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.

You may qualify if:

• 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;
• No distant metastasis;
• Age \>18 years old;
• Voluntary enrollment in the study and signing of an informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital, Yanchang Road, Jing'an District, Shanghai, China

Shanghai, Jingan, 200040, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Encopresis; Low Anterior Resection Syndrome; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Colonic Diseases; Postoperative Complications; Pathologic Processes

Study Officials

• Cheng-Le Zhuang, MD, PhD

  Shanghai Tenth People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2022
• Primary Completion: March 11, 2025
• Study Completion: April 11, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)