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

NCT ID: NCT06601985

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-04-11

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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J-pouch anastomosis group

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

J-pouch anastomosis

Intervention Type PROCEDURE

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.

direct anastomosis

Intervention Type PROCEDURE

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

Interventions

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J-pouch anastomosis

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

Intervention Type PROCEDURE

direct anastomosis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Feng-Min

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheng-Le Zhuang, MD, PhD

Role: STUDY_CHAIR

Shanghai Tenth People's Hospital

Locations

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

Shanghai, Jingan, China

Site Status

Countries

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China

Other Identifiers

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24K30

Identifier Type: -

Identifier Source: org_study_id

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