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

Primary Purpose

Crohn Disease, IBD, Ileocolitis

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Handsewn anastomosis

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Recurrence IBD, IBD, Endoscopic Recurrence, Rurgeers Score, Surgical recurrence, Crohn's Ileocolitis, Ileocolic Anastomosis, Crohn's disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

irccs San RaffaeleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Handsewn ileocolic anastomosis

Side to side stapled anastomosis

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Morbidity

postoperative morbidity measure

Clinical Recurrence

Clinical and surgical recurrence using Clavien Dindo

Inflammatory Bowel Disease Questionnaire (IBDQ)

Quality of life measured with IBD questionnaire

Hospital Costs

Hospital costs per patient in both groups

Full Information

NCT ID

NCT05246917

First Posted

February 9, 2022

Last Updated

May 25, 2022

Sponsor

IRCCS San Raffaele

1. Study Identification

Unique Protocol Identification Number

NCT05246917

Brief Title

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

Acronym

HAND2END

Official Title

Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 25, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, IBD, Ileocolitis, Crohn's Ileocolitis

Keywords

Recurrence IBD, IBD, Endoscopic Recurrence, Rurgeers Score, Surgical recurrence, Crohn's Ileocolitis, Ileocolic Anastomosis, Crohn's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised superiority study

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Handsewn ileocolic anastomosis

Arm Type

Experimental

Arm Description

Arm Title

Side to side stapled anastomosis

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Handsewn anastomosis

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Morbidity

Description

postoperative morbidity measure

Time Frame

1 year

Title

Clinical Recurrence

Description

Clinical and surgical recurrence using Clavien Dindo

Time Frame

1 year

Title

Inflammatory Bowel Disease Questionnaire (IBDQ)

Description

Quality of life measured with IBD questionnaire

Time Frame

1 year

Title

Hospital Costs

Description

Hospital costs per patient in both groups

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

vittoria bellato, MD

Phone

+447827422840

vittoria.bellato@gmail.com

Facility Information:

Facility Name

irccs San Raffaele

City

Milan

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Simona Radice

Phone

02.26432069

First Name & Middle Initial & Last Name & Degree

Vittoria Bellato, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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