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

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Kono anastomosis
Stapled side-to-side anastomosis
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn disease, ileocecal resection, anastomosis, Kono

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico IIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Kono anastomosis

Stapled side-to-side anastomosis

Arm Description

Patients receiving Kono anastomosis

Patients receiving stapled side-to-side anastomosis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Endoscopic recurrence
Presence of endoscopic recurrence
Grade of endoscopic recurrence
Severity of endoscopic recurrence at the site of anastomosis
Clinical recurrence
Presence of clinical recurrence (according to Crohn's disease activity index)
Operating time
Duration of the operation (min)
Anastomosis time
Time (min) required to perform the anastomosis
Anastomotic leak
Incidence of anastomotic leak
Surgical re-intervention
Rate of patients requiring surgical re-intervention
Postoperative morbidity rate
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
Recovery times
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

Full Information

First Posted
November 29, 2015
Last Updated
February 13, 2017
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02631967
Brief Title
Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease
Acronym
SuPREMeCD
Official Title
A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn disease, ileocecal resection, anastomosis, Kono

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kono anastomosis
Arm Type
Experimental
Arm Description
Patients receiving Kono anastomosis
Arm Title
Stapled side-to-side anastomosis
Arm Type
Experimental
Arm Description
Patients receiving stapled side-to-side anastomosis
Intervention Type
Procedure
Intervention Name(s)
Kono anastomosis
Intervention Description
Kono anastomosis
Intervention Type
Procedure
Intervention Name(s)
Stapled side-to-side anastomosis
Intervention Description
Stapled side-to-side anastomosis
Primary Outcome Measure Information:
Title
Grade of endoscopic recurrence
Description
Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
Time Frame
6 Months
Title
Surgical recurrence
Description
Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Endoscopic recurrence
Description
Presence of endoscopic recurrence
Time Frame
6 months up to 5 years
Title
Grade of endoscopic recurrence
Description
Severity of endoscopic recurrence at the site of anastomosis
Time Frame
6 months up to 5 years
Title
Clinical recurrence
Description
Presence of clinical recurrence (according to Crohn's disease activity index)
Time Frame
Up to 5 years
Title
Operating time
Description
Duration of the operation (min)
Time Frame
Intraoperatively
Title
Anastomosis time
Description
Time (min) required to perform the anastomosis
Time Frame
Intraoperatively
Title
Anastomotic leak
Description
Incidence of anastomotic leak
Time Frame
Up to 30 days
Title
Surgical re-intervention
Description
Rate of patients requiring surgical re-intervention
Time Frame
Up to 30 days
Title
Postoperative morbidity rate
Description
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
Time Frame
Up to 30 days
Title
Recovery times
Description
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
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Bucci, Prof
Phone
00390817462850
Email
luigi.bucci@unina.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Bucci, Prof
Organizational Affiliation
Federico II University of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II
City
Napoli
ZIP/Postal Code
80121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Bucci, Prof
Phone
00390817462850
Email
luigi.bucci@unina.it
First Name & Middle Initial & Last Name & Degree
Mariano Cesare Giglio, Dr
First Name & Middle Initial & Last Name & Degree
Gaetano Luglio, Dr
First Name & Middle Initial & Last Name & Degree
Fabiana Castiglione, Prof
First Name & Middle Initial & Last Name & Degree
Antonio Rispo, Dr
First Name & Middle Initial & Last Name & Degree
Giovanni Domenico De Palma, Prof

12. IPD Sharing Statement

Citations:
PubMed Identifier
21471760
Citation
Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.
Results Reference
background
PubMed Identifier
32675483
Citation
Luglio G, Rispo A, Imperatore N, Giglio MC, Amendola A, Tropeano FP, Peltrini R, Castiglione F, De Palma GD, Bucci L. Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial. Ann Surg. 2020 Aug;272(2):210-217. doi: 10.1097/SLA.0000000000003821.
Results Reference
derived

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

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