Back to resultsComparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
Primary Purpose
Crohn Disease, Recurrence
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Kono-S group
Side-to-side group
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility 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.
Sites / Locations
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Kono-S group
Side-to-side group
Arm Description
patients in this arm will receive stapled Kono-S anastomosis after bowel resection
patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection
Outcomes
Primary Outcome Measures
the endoscopic recurrence rate at 1 year after surgery
the endoscopic recurrence rate at 1 year after surgery
Secondary Outcome Measures
the clinical recurrence rate at 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
the surgical recurrence rate at 1 and 5 year after surgery
the endoscopic recurrence rate at 1 year after surgery
the endoscopic recurrence rate at 1 year after surgery
quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)
IBDQ ， higher means better，IBDQ，7-224；
quality of life for CD patients Short Form 12
Short Form 12 ， higher means better，Short Form-12， 0-12；
Full Information
NCT ID
NCT05658081
First Posted
December 2, 2022
Last Updated
December 17, 2022
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05658081
Brief Title
Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
236 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kono-S group
Arm Type
Experimental
Arm Description
patients in this arm will receive stapled Kono-S anastomosis after bowel resection
Arm Title
Side-to-side group
Arm Type
Other
Arm Description
patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection
Intervention Type
Procedure
Intervention Name(s)
Kono-S group
Intervention Description
patients in this arm will receive stapled Kono-S anastomosis after bowel resection
Intervention Type
Procedure
Intervention Name(s)
Side-to-side group
Intervention Description
patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection
Primary Outcome Measure Information:
Title
the endoscopic recurrence rate at 1 year after surgery
Description
the endoscopic recurrence rate at 1 year after surgery
Time Frame
at 1 year after surgery(6-18month)
Secondary Outcome Measure Information:
Title
the clinical recurrence rate at 1 and 5 year after surgery
Description
the clinical recurrence rate at 1 and 5 year after surgery
Time Frame
1 and 5 year after surgery
Title
the surgical recurrence rate at 1 and 5 year after surgery
Description
the surgical recurrence rate at 1 and 5 year after surgery
Time Frame
1 and 5 year after surgery
Title
the endoscopic recurrence rate at 1 year after surgery
Description
the endoscopic recurrence rate at 1 year after surgery
Time Frame
1 and 5 year after surgery
Title
quality of life for CD patients inflammatory bowel disease questionnaire(IBDQ)
Description
IBDQ ， higher means better，IBDQ，7-224；
Time Frame
1 and 5 year after surgery
Title
quality of life for CD patients Short Form 12
Description
Short Form 12 ， higher means better，Short Form-12， 0-12；
Time Frame
1 and 5 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ming duan, M.D.
Phone
+86-025-80860036
Email
duanming1206@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Li, Ph.D
Organizational Affiliation
Jinling Hospital，Nanjing， China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiming Zhu, PhD
Phone
86-25-80863736
Email
juwiming@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
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