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

Sponsor
Jinling Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05658081
Collaborator
(none)
236
1
2
83.8
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Kono-S group
  • Procedure: Side-to-side group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
236 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Stapled Antimesenteric Functional End-to-end Anastomosis (Kono-S) Versus Stapled Antimesenteric Isoperistaltic Side-to-side Anastomosis for the Postoperative Recurrence of Crohn's Disease: a Randomized Control Trial Study
Actual Study Start Date :
Dec 8, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Kono-S group

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

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

Other: Side-to-side group

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

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

Outcome Measures

Primary Outcome Measures

  1. the endoscopic recurrence rate at 1 year after surgery [at 1 year after surgery(6-18month)]

    the endoscopic recurrence rate at 1 year after surgery

Secondary Outcome Measures

  1. the clinical recurrence rate at 1 and 5 year after surgery [1 and 5 year after surgery]

    the clinical recurrence rate at 1 and 5 year after surgery

  2. the surgical 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

  3. the endoscopic recurrence rate at 1 year after surgery [1 and 5 year after surgery]

    the endoscopic recurrence rate at 1 year after surgery

  4. quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ) [1 and 5 year after surgery]

    IBDQ , higher means better,IBDQ,7-224;

  5. quality of life for CD patients Short Form 12 [1 and 5 year after surgery]

    Short Form 12 , higher means better,Short Form-12, 0-12;

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of General Surgery, Jinling hosptal,Medical School of Nanjing University Nanjing Jiangsu China 210002

Sponsors and Collaborators

  • Jinling Hospital, China

Investigators

  • Principal Investigator: Yi Li, Ph.D, Jinling Hospital,Nanjing, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhu Weiming, Jinling Hospital, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT05658081
Other Study ID Numbers:
  • jinlingH20221202
First Posted:
Dec 20, 2022
Last Update Posted:
Dec 20, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 20, 2022