Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study
Not applicable · Testing Kono-S group and Side-to-side group · 1 site · Jinling Hospital, China
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Kono-S group (a procedure) and Side-to-side group (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease and Recurrence.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 16 to 60
- Any sex
Some of the main requirements, copied from the record:
- patients with Crohn's disease needing bowel resection and anastomosis;
- ileocolic anastomosis；
- written consent acquired
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 236 participants are expected to take part.
- Start date: 2022-12-08.
- Main results expected around 2024-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- the endoscopic recurrence rate at 1 year after surgery (at 1 year after surgery(6-18month))
In the researchers’ words
The postoperative recurrence of Crohn's diseases (CD) remains high. Stapled anti-mesenteric functional end-to-end anastomosis was safe for CD patients.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Recurrence |
| Lead sponsor | Jinling Hospital, China |
| Enrollment | 236 (estimated) |
| Start date | 2022-12-08 |
| Primary completion (est.) | 2024-12 |
| First posted | 2022-12-20 |
| Last updated | 2022-12-20 |
| 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 |
| ClinicalTrials.gov ID | NCT05658081 |
Interventions
- Kono-S group (Procedure)
patients in this arm will receive stapled Kono-S anastomosis after bowel resection - Side-to-side group (Procedure)
patients in this arm will receive stapled antimesenteric isoperistaltic side-to-side anastomosis after bowel resection
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Department of General Surgery, Jinling hosptal,Medical School of Nanjing University | Nanjing, Jiangsu | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.