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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT03256240
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • side-to-side functional end anastomosis — OTHER
    type of anastomosis
  • Kono-S analstomosis — OTHER
    antimesenteric anastomosis

Study Details

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.

Key Dates

Start date
Mar 12, 2014
Status verified
May 2026
Primary completion
Jul 31, 2030
Completion
Dec 31, 2036

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: side-to-side functional end anastomosis
    side-to-side functional end anastomosis creation
  • Active Comparator: Kono-S
    antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis

Primary Outcome Measure

Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery [ Time Frame: 3-6 months after surgery ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-
Weill Cornell Medical CollegeNew YorkNew York10065
Koiana Ivanova Trencheva, BSN,M.S.
[email protected]
646-962-2342
University of OklahomaOklahoma CityOklahoma73112-
Baylor Scott & White Research InstituteDallasTexas75204-
Baylor College of MedicineHoustonTexas77030-
University of Washington Medical CenterSeattleWashington98195-

Find similar trials in Boston, MA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Massachusetts General Hospital· Boston, MAWeill Cornell Medical College· New York, NYUniversity of Oklahoma· Oklahoma City, OKBaylor Scott & White Research Institute· Dallas, TXBaylor College of Medicine· Houston, TXUniversity of Washington Medical Center· Seattle, WA

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