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

Jinling Hospital, China

Status: Enrolling

Conditions: Recurrence; Crohn Disease

Treatments: Procedure: Kono-S group; Procedure: Side-to-side group

Study type: Interventional

Funder types: Other

Identifiers

NCT05658081

jinlingH20221202

Details and patient eligibility

About

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.

Enrollment: 236 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 2 patient groups

Kono-S group

Experimental group

Description:

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

Treatment:

Procedure: Kono-S group

Side-to-side group

Other group

Description:

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

Treatment:

Procedure: Side-to-side group