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

Exploring the Effect of Applying Colonic J-pouch Forming in Anorectal Preservation Surgery for Ultra-low Rectal Cancer on Postoperative Bowel Control Function

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Anterior Resection Syndrome; Rectum Cancer; Faecal Incontinence; Leakage, Anastomotic; Faecal Incontinence with Faecal Urgency
• Intervention / Treatment: Procedure: J-pouch anastomosis; Procedure: direct anastomosis

• Study Type: Observational
• Enrollment (Estimated): 154

Contacts and Locations

Study Locations

• China
  • jingan
    • Shanghai, jingan, China, 200040
      • Shanghai Tenth People's Hospital, Yanchang Road, Jing'an District, Shanghai, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch.
direct anastomosis group; Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis.	Procedure: direct anastomosis; Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Records post-operative anastomotic fistula, infection, bleeding, etc.	From 1 month postoperatively to 12 months postoperatively

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Cheng-Le Zhuang, MD, PhD, Shanghai Tenth People&#39;s Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): March 11, 2025
• Study Completion (Estimated): April 11, 2025

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anastomotic Leak; Fecal Incontinence; Low Anterior Resection Syndrome
• Other Study ID Numbers: 24K30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No