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Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study

NCT ID: NCT05658081

Last Updated: 2022-12-20

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

RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-08

Study Completion Date

2029-12-31

Brief Summary

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The postoperative recurrence of Crohn's diseases (CD) remains high. Stapled anti-mesenteric functional end-to-end anastomosis was safe for CD patients. Its impact on the postoperative recurrence of CD was unknown. Whether it is superior than the conventional anastomosis (stapled antimesenteric isoperistaltic side-to-side anastomosis) needs explored. The trial aims to compare the different impacts of the two antimesenteric anastomosis configurations on the anastomotic recurrence following bowel resection.

Detailed Description

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Conditions

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Crohn Disease Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Kono-S group

patients in this arm will receive stapled Kono-S anastomosis after bowel resection

Group Type EXPERIMENTAL

Kono-S group

Intervention Type PROCEDURE

patients in this arm will receive stapled Kono-S anastomosis after bowel resection

Side-to-side group

patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection

Group Type OTHER

Side-to-side group

Intervention Type PROCEDURE

patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection

Interventions

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Kono-S group

patients in this arm will receive stapled Kono-S anastomosis after bowel resection

Intervention Type PROCEDURE

Side-to-side group

patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with Crohn's disease needing bowel resection and anastomosis;
* ileocolic anastomosis；
* written consent acquired

Exclusion Criteria

* patients underwent enterostomy;
* small bowel anastomosis;
* anticipating other trial.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Zhu Weiming

Jinling Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Li, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Jinling Hospital，Nanjing， China

Locations

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Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ming duan, M.D.

Role: CONTACT

Phone: +86-025-80860036

Email: [email protected]

Facility Contacts

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Weiming Zhu, PhD

Role: primary

Other Identifiers

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jinlingH20221202

Identifier Type: -

Identifier Source: org_study_id