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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658081
• Other study ID #: jinlingH20221202
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: December 2029

Study information

• Verified date: December 2022
• Source: Jinling Hospital, China
• Contact: ming duan, M.D.
• Phone: +86-025-80860036
• Email: duanming1206[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 2029
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Recurrence

Intervention

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

Locations

Country	Name	City	State
China	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	the endoscopic recurrence rate at 1 year after surgery	the endoscopic recurrence rate at 1 year after surgery	1 and 5 year after surgery
Secondary	quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)	IBDQ , higher means better,IBDQ,7-224;	1 and 5 year after surgery
Secondary	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