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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Crohn Disease
• Intervention / Treatment: Procedure: Kono-S group; Procedure: Side-to-side group

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ming duan, M.D.; Phone Number: +86-025-80860036; Email: duanming1206@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
      • Contact: Weiming Zhu, PhD; Phone Number: 86-25-80863736; Email: juwiming@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the clinical recurrence rate at 1 and 5 year after surgery	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	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	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)	IBDQ ， higher means better，IBDQ，7-224；	1 and 5 year after surgery
quality of life for CD patients Short Form 12	Short Form 12 ， higher means better，Short Form-12， 0-12；	1 and 5 year after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Estimate): December 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Crohn Disease
• Other Study ID Numbers: jinlingH20221202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No