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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

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.

Condition or disease Intervention/treatment Phase
Postoperative Surgical Recurrence Procedure: Extensive mesenteric resection Procedure: Limited mesenteric excision Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Extensive mesenteric resection
Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
Procedure: Extensive mesenteric resection
The mesentery is resected avoiding the root region.

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).
Procedure: Limited mesenteric excision
The mesentery is retained.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.


Other Outcome Measures:
  1. postoperative operation-related complications [ Time Frame: 30 day ]
    30-day postoperative morbidity



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03769922


Contacts
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Contact: Li Yi, PhD +86 13851843735 liyi.jlh@hotmail.com

Locations
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China, Jiangsu
General Hospital of Eastern Theater Command Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Yi Li         
Sponsors and Collaborators
Jinling Hospital, China
University Hospital of Limerick
The Cleveland Clinic
Sixth Affiliated Hospital, Sun Yat-sen University
Sir Run Run Shaw Hospital
Investigators
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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

Additional Information:
Publications:
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Responsible Party: Weiming Zhu, Chief of general surgery, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03769922     History of Changes
Other Study ID Numbers: 2018NZKY-025-02
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
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

Additional relevant MeSH terms:
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Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes