Actively Recruiting

Phase Not Applicable
Age: 16Years - 60Years
All Genders
ID05658081

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

Age: 16Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Crohn's disease needing bowel resection and anastomosis
  • Ileocolic anastomosis planned
  • Written consent acquired
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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