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

IRCCS San Raffaele189 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

189

Conditions

Crohn Disease IBD Ileocolitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females aged \>18 years * Ileocolic disease or disease of the neoterminal ileum with an indication for resection * Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted. * All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease. * Ability to comply with protocol. * Competent and able to provide written informed consent. * Patient must have been discussed in the local MDT Exclusion Criteria: * Inability to give informed consent. * Patients less than 16 years of age. * Patients undergoing repeated ileocolic resection. * History of cancer \< 5 years which might influence patients prognosis * Emergent operation. Pregnant or breast feeding.

Outcomes

Primary Outcomes

6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.

The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification.

Time frame: 6 months

Secondary Outcomes

Morbidity

postoperative morbidity measure

Time frame: 1 year

Clinical Recurrence

Clinical and surgical recurrence using Clavien Dindo

Time frame: 1 year

Inflammatory Bowel Disease Questionnaire (IBDQ)

Quality of life measured with IBD questionnaire

Time frame: 1 year

Hospital Costs

Hospital costs per patient in both groups

Time frame: 1 year

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts