NCT05658081

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Dec 2022Dec 2029

First Submitted

Initial submission to the registry

December 2, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

December 8, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Expected
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

December 2, 2022

Last Update Submit

December 17, 2022

Conditions

Crohn DiseaseRecurrence

Outcome Measures

Primary Outcomes (1)

  • the endoscopic recurrence rate at 1 year after surgery

    the endoscopic recurrence rate at 1 year after surgery

    at 1 year after surgery(6-18month)

Secondary Outcomes (5)

  • the clinical recurrence rate at 1 and 5 year after surgery

    1 and 5 year after surgery

  • the surgical recurrence rate at 1 and 5 year after surgery

    1 and 5 year after surgery

  • the endoscopic recurrence rate at 1 year after surgery

    1 and 5 year after surgery

  • quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)

    1 and 5 year after surgery

  • quality of life for CD patients Short Form 12

    1 and 5 year after surgery

Study Arms (2)

Kono-S group

EXPERIMENTAL

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

Procedure: Kono-S group

Side-to-side group

OTHER

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

Procedure: Side-to-side group

Interventions

Kono-S groupPROCEDURE

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

Kono-S group
Side-to-side groupPROCEDURE

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

Side-to-side group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • patients underwent enterostomy;
  • small bowel anastomosis;
  • anticipating other trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Crohn DiseaseRecurrence

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yi Li, Ph.D

    Jinling Hospital，Nanjing， China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ming duan, M.D.

CONTACT

+86-025-80860036duanming1206@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jinling Hospital

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 20, 2022

Study Start

December 8, 2022

Primary Completion

December 1, 2024

Study Completion (Estimated)

December 1, 2029

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)