MedTrace Logo

Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease

NCT05246917 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2022-05-31

No results posted yet for this study

Summary

RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.

HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction.

DESIGN Randomised superiority study

POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum

INTERVENTION Kono S and end to end hand sewn anastomosis

USUAL CARE Side to side stapled anastomosis

OUTCOME Endoscopic recurrence (local and central reading) at 6 months

SAMPLE 25% reduction in 2:1 ratio -\> 126 + 63 = 189 patients

KEYWORDS Crohn, ileocolic resection, recurrence

Conditions

  • Crohn Disease
  • IBD
  • Ileocolitis
  • Crohn's Ileocolitis

Interventions

PROCEDURE

Handsewn anastomosis

To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05246917 on ClinicalTrials.gov