Actively Recruiting

Phase Not Applicable
Age: 14Years - 65Years
All Genders
NCT06241170

Mesenteric Surgical Margin for Crohn's Disease Endoscopic Recurrence

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-07-15

172

Participants Needed

1

Research Sites

339 weeks

Total Duration

On this page

Sponsors

S

Sixth Affiliated Hospital, Sun Yat-sen University

Lead Sponsor

J

Jinling Hospital, China

Collaborating Sponsor

AI-Summary

What this Trial Is About

Despite significant advancements in the treatment of Crohn's disease (CD), approximately 50% of patients undergo surgical intervention within ten years of diagnosis. Furthermore, more than 70% of these patients experience endoscopic recurrence within one year after surgery. This subset of patients often faces a poorer long-term prognosis and requires long-term intensified medical therapy. Therefore, reducing early postoperative endoscopic recurrence has remained a crucial focus in CD research. From a surgical perspective, there have been limited breakthroughs in improving surgical techniques to reduce the postoperative endoscopic recurrence rate in CD. Recent research indicates that microscopic inflammation at the cut edge of the CD bowel segment is a significant risk factor for postoperative endoscopic recurrence. Mesenteric wrapping is a unique clinical pathological feature of CD. Our retrospective data suggest a clear linear correlation between the degree of mesenteric wrapping and microscopic inflammation in the corresponding bowel segment. Surgical margins determined by mesenteric guidance significantly reduce the postoperative endoscopic recurrence rate and clinical relapse rate compared to the traditional 2 cm margin. However, there is currently no prospective study comparing the efficacy of these two surgical approaches.To address this, investigators plan to conduct a multicenter randomized controlled trial. This trial will focus on patients with ileocolonic CD who have undergone primary anastomosis without residual disease. investigators aim to compare the postoperative endoscopic recurrence rates between mesenteric-guided margins and the traditional 2 cm margins. Our goal is to determine whether mesenteric-guided margins can reduce the postoperative endoscopic recurrence rate and to conduct relevant mechanistic research. Ultimately, this research may lead to the development of a novel surgical approach for CD based on the findings of this study.

CONDITIONS

Official Title

Mesenteric Surgical Margin for Crohn's Disease Endoscopic Recurrence

Who Can Participate

Age: 14Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a confirmed diagnosis of Crohn's disease scheduled for one-stage ileocecal resection
  • Localized ileocecal Crohn's disease involving the terminal ileum and cecum with total lesion length under 80 cm
  • No residual lesions within 50 cm proximal to the ileocecal anastomosis
  • Patients or legal guardians able to understand the study, provide written informed consent, and comply with the protocol
Not Eligible

You will not qualify if you...

  • History of ileocecal resection
  • Primary lesions in locations other than the ileocecal region requiring resection
  • Risk of short bowel syndrome
  • Need for ileostomy formation
  • Severe anorectal lesions
  • Predicted inability to receive postoperative drug therapy
  • Unable to return for timely hospital re-examinations
  • Serious illness within 6 months before surgery (e.g., myocardial infarction, active angina, heart failure)
  • History of malignant tumors including melanoma (except localized skin cancer)
  • Diagnosed with autoimmune diseases other than Crohn's disease
  • Pregnant or lactating patients
  • Unable to be tracked for primary outcome measurements
  • Loss to follow-up or voluntary withdrawal
  • Occurrence of anastomotic fistula after surgery affecting endoscopic evaluation
  • Investigator judgment deeming unsuitability for continued participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jia Ke

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

J

Jun H, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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