Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550843
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Mesentery Guide Identify Microscopic Clean Resection and Reduces Crohns Endoscopic Recurrence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mesentery Abnormality to Identify Microscopic Clean Resection and Reduce Postoperative Endoscopic Recurrence in Ileocolic Crohns Disease
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohns disease CD We aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence after ileocolic resection
Detailed Description:
Despite proactive prophylactic treatment administered after surgery for Crohns disease CD patients early postoperative endoscopic recurrence EPER still occurs in 50-80 of patients within six months increasing the risk of long-term clinical and surgical recurrence Risk factors for EPER have already been identified including active smoking disease behavior younger age concomitant perianal disease prior intestinal resections and microscopic resection margin positivity Recently the influence of microscopic inflammation at the resection margin on EPER has been highlighted by various studies and meta-analysis
From a surgical perspective it has become common practice to conservatively resect 2cm width from the gross lesion to lower re-operation risks while the optimal strategy to attain the microscopic clean margin and minimize EPER remain unclear considering the limited accuracy of frozen-section examinations More importantly the diseased mucosa proximal to the ileal lesion can be healed by preoperative optimization potentially concealing deeper lesions at the muscularis propria and serosal levels from visual assessment during surgery Therefore identifying a macroscopic marker that highly correlates with microscopic inflammation is essential to help locate the clean division
As a hallmark of CD the hyperplasia of mesenteric adipose tissue MAT or Creeping fat was found directly triggered by transmural inflammation and bacterial translocation from CD affected lumen11 Correspondingly creeping fat has been found to correlate with macroscopic mucosal abnormalities observed after opening the bowel12 However its relationship with microscopic inflammation as well as its potential role in determining the division position to achieve better EPER outcomes remains to be clarified
From a surgical perspective it has become common practice to conservatively resect 2cm width from the gross lesion to lower re-operation risks while the optimal strategy to attain the microscopic clean margin and minimize EPER remain unclear considering the limited accuracy of frozen-section examinations More importantly the diseased mucosa proximal to the ileal lesion can be healed by preoperative optimization potentially concealing deeper lesions at the muscularis propria and serosal levels from visual assessment during surgery Therefore identifying a macroscopic marker that highly correlates with microscopic inflammation is essential to help locate the clean division
As a hallmark of CD the hyperplasia of mesenteric adipose tissue MAT or Creeping fat was found directly triggered by transmural inflammation and bacterial translocation from CD affected lumen11 Correspondingly creeping fat has been found to correlate with macroscopic mucosal abnormalities observed after opening the bowel12 However its relationship with microscopic inflammation as well as its potential role in determining the division position to achieve better EPER outcomes remains to be clarified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None