Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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;
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of General Surgery, Jinling hosptal,Medical School of Nanjing University | Nanjing | Jiangsu | China | 210002 |
Sponsors and Collaborators
- Jinling Hospital, China
Investigators
- Principal Investigator: Yi Li, Ph.D, Jinling Hospital,Nanjing, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- jinlingH20221202