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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn Disease, Recurrence

Intervention / Treatment
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* Procedure: Kono-S group
* Procedure: Side-to-side group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kono-S group<br>patients in this arm will receive stapled Kono-S anastomosis after bowel resection | Procedure: Kono-S group<br>* patients in this arm will receive stapled Kono-S anastomosis after bowel resection<br>|
| Other: Side-to-side group<br>patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection | Procedure: Side-to-side group<br>* patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection<br>|

What is the study measuring?
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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 |