Menu
Recruiting NCT05658081

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

No phase Interventional Crohn Disease Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kono-S group, Side-to-side group.
Who it may be relevant to
Registry conditions: Crohn Disease, Recurrence. Basic parameters: 16 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Kono-S group
    patients in this arm will receive stapled Kono-S 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

Primary outcome measures

  • the endoscopic recurrence rate at 1 year after surgery [Time frame: at 1 year after surgery(6-18month)]
Secondary outcome measures (5)
  • the clinical recurrence rate at 1 and 5 year after surgery [Time frame: 1 and 5 year after surgery]
  • the surgical recurrence rate at 1 and 5 year after surgery [Time frame: 1 and 5 year after surgery]
  • the endoscopic recurrence rate at 1 year after surgery [Time frame: 1 and 5 year after surgery]
  • quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ) [Time frame: 1 and 5 year after surgery]
  • quality of life for CD patients Short Form 12 [Time frame: 1 and 5 year after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of General Surgery, Jinling hosptal,Medical School of Nanjing University — Nanjing

Identifiers

NCT: NCT05658081 · jinlingH20221202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗