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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05658081

Enrollment

236

Registered

2022-12-20

Start date

2022-12-08

Completion date

2029-12-31

Last updated

2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Recurrence

Brief 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.

Interventions

PROCEDUREKono-S group

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

PROCEDURESide-to-side group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
the endoscopic recurrence rate at 1 year after surgery	at 1 year after surgery(6-18month)	the endoscopic recurrence rate at 1 year after surgery

Secondary

Measure	Time frame	Description
the clinical recurrence rate at 1 and 5 year after surgery	1 and 5 year after surgery	the clinical 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 surgical recurrence rate at 1 and 5 year after surgery
the endoscopic recurrence rate at 1 year after surgery	1 and 5 year after surgery	the endoscopic recurrence rate at 1 year after surgery
quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)	1 and 5 year after surgery	IBDQ ， higher means better，IBDQ，7-224；
quality of life for CD patients Short Form 12	1 and 5 year after surgery	Short Form 12 ， higher means better，Short Form-12， 0-12；

Countries

China

Contacts

Primary Contactming duan, M.D.

duanming1206@126.com+86-025-80860036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026