Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease (SuPREMeCD)

February 13, 2017 updated by: Luigi Bucci, Federico II University

A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial

Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD).

This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.

In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery.

Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80121
        • Recruiting
        • UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II
        • Contact:
        • Sub-Investigator:
          • Mariano Cesare Giglio, Dr
        • Sub-Investigator:
          • Gaetano Luglio, Dr
        • Sub-Investigator:
          • Fabiana Castiglione, Prof
        • Sub-Investigator:
          • Antonio Rispo, Dr
        • Sub-Investigator:
          • Giovanni Domenico De Palma, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Crohn's disease requiring ileocecal resection

Exclusion Criteria:

  • age > 75 years
  • age < 18 years
  • inability to give the consent to the participation in the trial
  • refusal to participate in the trial after receiving accurate information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kono anastomosis
Patients receiving Kono anastomosis
Procedure: Kono anastomosis
Kono anastomosis
Experimental: Stapled side-to-side anastomosis
Patients receiving stapled side-to-side anastomosis
Procedure: Stapled side-to-side anastomosis
Stapled side-to-side anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of endoscopic recurrence
Time Frame: 6 Months
Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
6 Months
Surgical recurrence
Time Frame: Up to 5 years
Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic recurrence
Time Frame: 6 months up to 5 years
Presence of endoscopic recurrence
6 months up to 5 years
Grade of endoscopic recurrence
Time Frame: 6 months up to 5 years
Severity of endoscopic recurrence at the site of anastomosis
6 months up to 5 years
Clinical recurrence
Time Frame: Up to 5 years
Presence of clinical recurrence (according to Crohn's disease activity index)
Up to 5 years
Operating time
Time Frame: Intraoperatively
Duration of the operation (min)
Intraoperatively
Anastomosis time
Time Frame: Intraoperatively
Time (min) required to perform the anastomosis
Intraoperatively
Anastomotic leak
Time Frame: Up to 30 days
Incidence of anastomotic leak
Up to 30 days
Surgical re-intervention
Time Frame: Up to 30 days
Rate of patients requiring surgical re-intervention
Up to 30 days
Postoperative morbidity rate
Time Frame: Up to 30 days
Postoperative surgical (bleeding, obstruction, postoperative ileus, abdominal collection, wound infection) and medical morbidity as well as mortality will be documented and graded according to the Dindo Clavien classification
Up to 30 days
Recovery times
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Length of post-operative hospital stay, time to first flatus, time to first defecation, time to tolerance of liquid and solid diet will be documented
Participants will be followed for the duration of hospital stay, an expected average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Luigi Bucci, Prof, Federico II University of Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

November 29, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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