Comparing two surgical methods for Crohn's disease treatment
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
This study is testing which of two surgical methods works better for treating Crohn's disease in patients needing bowel surgery to see which one leads to fewer problems after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05658081 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different surgical techniques for performing anastomosis in patients with Crohn's disease who require bowel resection. One method involves a stapled anti-mesenteric functional end-to-end anastomosis, while the other uses a stapled antimesenteric isoperistaltic side-to-side anastomosis. The study will evaluate the postoperative recurrence rates of Crohn's disease associated with each technique. By determining which method is superior, the trial seeks to improve surgical outcomes for patients with this chronic condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Crohn's disease who require bowel resection and anastomosis.
Not a fit: Patients who have undergone enterostomy or small bowel anastomosis, or those anticipating participation in another trial, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced recurrence rates of Crohn's disease after surgery, improving patient quality of life.
How similar studies have performed: While the specific comparison of these two anastomosis techniques may be novel, previous studies have shown varying success with different surgical approaches for Crohn's disease.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Yi Li, Ph.D — Jinling Hospital，Nanjing， China
- Study coordinator: ming duan, M.D.
- Email: duanming1206@126.com
- Phone: +86-025-80860036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.