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Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03769922
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
University Hospital of Limerick
The Cleveland Clinic
Sixth Affiliated Hospital, Sun Yat-sen University
Sir Run Run Shaw Hospital
Information provided by (Responsible Party):
Weiming Zhu, Jinling Hospital, China

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Accumulated 5-year postoperative surgical recurrence [ Time Frame: 5 years after the first surgery ]
The requirement for repeat surgery for a Crohn's disease related indication.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Postoperative surgical recurrence [ Time Frame: 5 years after the first surgery ]
The requirement for repeat surgery for a Crohn's disease related indication.
Change History Complete list of historical versions of study NCT03769922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • Accumulated 5-year endoscopic recurrence [ Time Frame: 5 years after the first surgery ]
    Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence)
  • Accumulated 5-year clinical recurrence [ Time Frame: 5 years after the first surgery ]
    The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Endoscopic recurrence [ Time Frame: 5 years after the first surgery ]
    Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence)
  • Clinical recurrence [ Time Frame: 5 years after the first surgery ]
    The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment.
Current Other Pre-specified Outcome Measures
 (submitted: December 6, 2018)
postoperative operation-related complications [ Time Frame: 30 day ]
30-day postoperative morbidity
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease
Official Title  ICMJE The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
Brief Summary The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.
Detailed Description

EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.

EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.

LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Surgical Recurrence
Intervention  ICMJE
  • Procedure: Extensive mesenteric resection
    The mesentery is resected avoiding the root region.
  • Procedure: Limited mesenteric excision
    The mesentery is retained.
Study Arms  ICMJE
  • Experimental: Extensive mesenteric resection
    Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
    Intervention: Procedure: Extensive mesenteric resection
  • Active Comparator: Limited mesenteric excision
    Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
    Intervention: Procedure: Limited mesenteric excision
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
  • Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria

Exclusion Criteria:

  • Pregnancy or willingness to become pregnant in the following year
  • Previous ileocolic resection history
  • Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
  • Patients having an internal fistula which required resection of another segment of bowel
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Li Yi, PhD +86 13851843735 liyi.jlh@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769922
Other Study ID Numbers  ICMJE 2018NZKY-025-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weiming Zhu, Jinling Hospital, China
Study Sponsor  ICMJE Jinling Hospital, China
Collaborators  ICMJE
  • University Hospital of Limerick
  • The Cleveland Clinic
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • Sir Run Run Shaw Hospital
Investigators  ICMJE
Principal Investigator: Zhu Weiming Jinling Hospital, Nanjing, China.
Principal Investigator: John Calvin Coffey University Hospital Limerick, Limerick, Ireland.
Principal Investigator: Luca Stocchi The Cleveland Clinic
PRS Account Jinling Hospital, China
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP