KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease
Not applicable · Testing Kono-S anastomosis and Conventional anastomosis for ileocolonicresection of Crohn's… · 15 sites · Centre Hospitalier Universitaire de Besancon
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Kono-S anastomosis (a procedure) and Conventional anastomosis for ileocolonicresection of Crohn's disease (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease.
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 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Adult patient ≥ 18 years and ≤75 years
- With Crohn's disease.
- Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease or disease refractory to medical treatment.
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 226 participants are expected to take part.
- Start date: 2025-03 (planned).
- Main results expected around 2027-07 (estimate from the record).
- 15 study sites listed (1 marked recruiting) in France.
Main thing being measured
- endoscopy score (Month 6)
In the researchers’ words
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) currently affecting one person in a thousand in France. It can lead to numerous digestive complications such as fistulas, abscesses or stenosis.
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 |
| Lead sponsor | Centre Hospitalier Universitaire de Besancon |
| Enrollment | 226 (estimated) |
| Start date | 2025-03 |
| Primary completion (est.) | 2027-07 |
| First posted | 2023-08-03 |
| Last updated | 2025-02-13 |
| Official title | KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease: a Superiority Phase III Prospective, Randomized, Multicenter, Double-blind Trial. |
| ClinicalTrials.gov ID | NCT05974358 |
Interventions
- Kono-S anastomosis (Procedure)
Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). - Conventional anastomosis for ileocolonicresection of Crohn's disease (Procedure)
conventional anastomosis for ileocolonicresection of Crohn's disease
Full eligibility criteria (from the record)
Inclusion Criteria: * Adult patient ≥ 18 years and ≤75 years * With Crohn's disease. * Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease or disease refractory to medical treatment. * Affiliated to the French social security system. Exclusion Criteria: * Previous ileocolonic resection * Contraindication to postoperative endoscopy. * Anastomosis with a planned defunctioning protective stoma. * Emergency surgery (peritonitis). * Lack of consent to the study. * Pregnant patients. * Refusal to participate or inability to provide informed consent. * Patient under legal protection (individuals under guardianship by court order)
Locations (15)
| Site | City | Country | Site status |
|---|---|---|---|
| CHu de Besançon | Besançon | France | Recruiting |
| CHU de Bordeaux | Bordeaux | France | Not yet recruiting |
| CHU de Grenoble | Grenoble | France | Not yet recruiting |
| CHU de Lille Hopital Claude Huriez | Lille | France | Not yet recruiting |
| HCL-Hôpital Lyon Sud | Lyon | France | Not yet recruiting |
| AP-HM Hôpital Nord | Marseille | France | Not yet recruiting |
| CHU de Nançy | Nancy | France | Not yet recruiting |
| CHU de Nantes | Nantes | France | Not yet recruiting |
| Ap-HP Hopital St Louis | Paris | France | Not yet recruiting |
| AP-HP Hôpital Européen Georges Pompidou | Paris | France | Not yet recruiting |
| AP-HP Le Kremlin-Bicetre | Paris | France | Not yet recruiting |
| AP-HP St Antoine | Paris | France | Not yet recruiting |
| CHU de Rennes | Rennes | France | Not yet recruiting |
| CHU de Strasbourg HautePierre | Strasbourg | France | Not yet recruiting |
| CHU de Toulouse | Toulouse | France | Not yet 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.