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Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease (HAND2END)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05246917
Recruitment Status : Recruiting
First Posted : February 18, 2022
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Vittoria Bellato, IRCCS San Raffaele

Study Description
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Brief 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


Condition or disease Intervention/treatment Phase
Crohn Disease IBD Ileocolitis Crohn's Ileocolitis Procedure: Handsewn anastomosis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised superiority study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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

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


Outcome Measures
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Primary Outcome Measures :
  1. 6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification. [ Time Frame: 6 months ]
    The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification.


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 1 year ]
    postoperative morbidity measure

  2. Clinical Recurrence [ Time Frame: 1 year ]
    Clinical and surgical recurrence using Clavien Dindo

  3. Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 1 year ]
    Quality of life measured with IBD questionnaire

  4. Hospital Costs [ Time Frame: 1 year ]
    Hospital costs per patient in both groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05246917


Contacts
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Contact: vittoria bellato, MD +447827422840 vittoria.bellato@gmail.com

Locations
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Italy
irccs San Raffaele Recruiting
Milan, Italy
Contact: Simona Radice    02.26432069      
Principal Investigator: Vittoria Bellato, MD         
Sponsors and Collaborators
IRCCS San Raffaele
More Information
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Responsible Party: Vittoria Bellato, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT05246917    
Other Study ID Numbers: 5.2
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vittoria Bellato, IRCCS San Raffaele:
Recurrence IBD
IBD
Endoscopic Recurrence
Rurgeers Score
 Surgical recurrence
Crohn's Ileocolitis
Ileocolic Anastomosis
Crohn's disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases