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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Crohn Disease IBD Ileocolitis Crohn's Ileocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised superiority study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Handsewn ileocolic anastomosis

Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis.

to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring

Group Type EXPERIMENTAL

Handsewn anastomosis

Intervention Type PROCEDURE

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

Side to side stapled anastomosis

Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis.

to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Handsewn anastomosis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No