Comparing two surgical joining methods after bowel removal in Crohn's disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who need their first surgery to remove part of the small intestine and colon (ileocolonic resection).

Age

18 to 75 years

Sex

All sexes can join.

Disease stage

Crohn's disease needing a first ileocolonic resection because of fistulas, abscesses, narrowing (stenosis), or disease that does not respond to medical treatment.

Earlier treatment

No earlier ileocolonic resection.

Main reasons for not taking part

• Earlier ileocolonic resection
• Cannot have an endoscopy after surgery
• Planned protective stoma with the anastomosis
• Emergency surgery (peritonitis)
• Pregnant patients

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

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. Despite numerous therapeutic advances, the rate of patients requiring surgery remains very high, with approximately 50% requiring at least one surgical intervention at 10 years after disease diagnosis. However, surgical treatment is not curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic recurrence at 1 year. The ileocolonic anastomosis is the main site of postoperative recurrence currently defined by a Rutgeerts score (≥i2) 6 months after surgery. In 2003, 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). The study showed no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease in surgical recurrence rate at 5 years (15% vs 0%). Recently, a randomized Italian monocenter study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2% versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. The limitations of this study are its monocentric nature and the lack of centralization of the endoscopic analysis to assess the primary endpoint. This surgical technique has been performed in some centers for ileocolonic Crohn's surgery since 2020. Nevertheless, the level of evidence remains too low to establish practice recommendations. The KOALA study will be the first prospective, multicenter, randomized study comparing KONO-S anastomosis and conventional anastomosis for ileocolonicresection of Crohn's disease, with blinded and centralized evaluation of recurrence.

The 2 groups in the trial

• Kono-S groupTreatment being tested

  Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.

  Treatment: Kono-S anastomosis

• Control groupOther group

  Conventional side-to-side ileocolonic anastomosis

  Treatment: Conventional anastomosis for ileocolonicresection of Crohn's disease