Actively Recruiting
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
Led by Jinling Hospital, China · Updated on 2022-12-20
236
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of stapled antimesenteric anastomosis techniques used after bowel resection in patients with Crohn's disease to see which is better at reducing postoperative recurrence. Crohn's disease can often return after surgery, and while the stapled anti-mesenteric functional end-to-end anastomosis (Kono-S) has been found safe, its benefit over the conventional stapled antimesenteric isoperistaltic side-to-side anastomosis is unknown. This randomized control trial aims to explore the difference in recurrence rates following these two surgical methods. Participants will be randomly assigned to receive either the stapled Kono-S anastomosis or the stapled antimesenteric isoperistaltic side-to-side anastomosis after their bowel resection. Both are surgical procedures performed during the operation to reconnect the bowel. The study will monitor the patients over time to compare the outcomes of these two anastomosis techniques. Throughout the study, researchers will assess the endoscopic recurrence rate of Crohn's disease one year after surgery, which is the primary outcome measure. Secondary outcomes include clinical and surgical recurrence rates at one and five years post-surgery, as well as quality of life assessments using the inflammatory bowel disease questionnaire (IBDQ) and Short Form 12 surveys. The study is double-blinded and randomized, with participants aged 16 to 60 years, and involvement may last several years to capture these outcomes.
CONDITIONS
Brief Title
Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Crohn's disease needing bowel resection and anastomosis
- Ileocolic anastomosis planned
- Written consent acquired
You will not qualify if you...
- Patients who have undergone enterostomy
- Small bowel anastomosis
- Currently participating in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day plus immediate post-operative period
Participants undergo bowel resection followed by either stapled Kono-S anastomosis or stapled antimesenteric isoperistaltic side-to-side anastomosis as assigned.
1 surgery visit and immediate post-operative care
Duration - Up to 5 years after surgery
Participants are monitored for recurrence and quality of life after surgery, with assessments at 1 and 5 years.
Visits at 1 year and 5 years post-surgery
Trial Site Locations
Total: 1 location
1
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Actively Recruiting
Research Team
M
ming duan, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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