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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05246917
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 IRCCS San Raffaele
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Crohn Disease, IBD, Ileocolitis, Crohn's Ileocolitis
Arms & Interventions

Arms

Experimental: 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

No Intervention: 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

Interventions

Procedure: - Handsewn anastomosis

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

irccs San Raffaele, Milan, Italy

Status

Recruiting

Address

irccs San Raffaele

Milan, ,

Site Contact

Simona Radice

vittoria.bellato@gmail.com

02.26432069

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