Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03769922|
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Surgical Recurrence||Procedure: Extensive mesenteric resection Procedure: Limited mesenteric excision||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- postoperative operation-related complications [ Time Frame: 30 day ]30-day postoperative morbidity
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
|Contact: Li Yi, PhD||+86 firstname.lastname@example.org|
|General Hospital of Eastern Theater Command||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: Yi Li|
|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|