Mesentery Guide Identify Microscopic Clean Resection and Reduces Crohn's Endoscopic Recurrence

August 8, 2024 updated by: Jia Ke, Sixth Affiliated Hospital, Sun Yat-sen University

Mesentery Abnormality to Identify Microscopic Clean Resection and Reduce Postoperative Endoscopic Recurrence in Ileocolic Crohn's Disease

Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohn's 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite proactive prophylactic treatment administered after surgery for Crohn's 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.

Study Type

Observational

Enrollment (Actual)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

For the pathological study, we prospectively enrolled consecutive CD patients who underwent ileocolic resections between January 2021 and August 2021 at the 6th Hospital of Sun Yat-Sen University (SYSU6H) For the surgical study, we retrospectively enrolled consecutive CD patients that underwent ileocolic resection from January 2013 to July 2020

Description

Inclusion Criteria:

  • Localized ileocolic CD

Exclusion Criteria:

  • Patients with a stoma,residuallesion ,history of bowel resection,or post-operative abdominalinfection were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
conventional group
In the conventional group, the cutting line was approximately 2cm proximal to the macroscopic lesion where the mucosa and intestinal wall appeared macroscopically normal, regardless of the adjacent mesentery.
mesentery-guided group (Mes-G)
In the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp.
Procedure: mesentery-guided division
In the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Crohn's Endoscopic Recurrence
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sixth Affiliated Hospital 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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