RecruitingNot Applicable

Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis

United States600 participantsStarted 2014-03-12

Plain-language summary

This study proposes a randomized prospective study comparing the Kono-S anastomosis to the standard side-to-side anastomosis.This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
✓. Age of 18 years and older, male and female
✓. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
✓. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.

Exclusion criteria

✕. Patients under 18 years of age
✕. Patients with recurrent Crohn's
✕. Pregnant patients
✕. Patients with more than one non-contiguous site of active disease, thus requiring multiple resections or additional bowel sparing procedures at the time of surgery.
✕. Patients with Crohn's disease extending to the cecum and ascending colon
✕. Patients who will need preventive postoperative medical treatment
✕. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

What they're measuring

Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery

Timeframe: 3-6 months after surgery

Number of subjects with surgical recurrence at 60 months

Timeframe: 60 months after surgery

Number of subjects with surgical recurrence at 120 months

Timeframe: 120 months after surgery

Mucosal Healing GHS

Timeframe: 60 months after surgery

Mucosal Healing IBD-DCA

Timeframe: 60 months after surgery

Surgical Pathology Margins

Timeframe: at surgery

Trial details

NCT IDNCT03256240

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-07-31

Contact for this trial

Koianka Trencheva, Dr.PH,BSN,MS

646-962-2342 kivanova@med.cornell.edu

View on ClinicalTrials.gov More Crohn's Disease trials

Plain-language summary

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
✓. Age of 18 years and older, male and female
✓. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
✓. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.

Exclusion criteria

✕. Patients under 18 years of age
✕. Patients with recurrent Crohn's
✕. Pregnant patients
✕. Patients with more than one non-contiguous site of active disease, thus requiring multiple resections or additional bowel sparing procedures at the time of surgery.
✕. Patients with Crohn's disease extending to the cecum and ascending colon
✕. Patients who will need preventive postoperative medical treatment
✕. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

What they're measuring

Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery

Timeframe: 3-6 months after surgery

Number of subjects with surgical recurrence at 60 months

Timeframe: 60 months after surgery

Number of subjects with surgical recurrence at 120 months

Timeframe: 120 months after surgery

Mucosal Healing GHS

Timeframe: 60 months after surgery

Mucosal Healing IBD-DCA

Timeframe: 60 months after surgery

Surgical Pathology Margins

Timeframe: at surgery