RecruitingNot ApplicableNCT06241170

Mesenteric Surgical Margin for Crohn's Disease Endoscopic Recurrence

Mesentery Guided Bowel Resection Margin Versus Traditional Margin in Reducing Early Endoscopic Recurrence Rate After Ileocolic Resection in Patients With Crohn 's Disease:a Prospective, Multicenter, Randomized Controlled Clinical Trial


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

172 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different surgical techniques for removing the ileocecal region (the junction of the small and large intestines) in people with Crohn's disease, with a focus on which approach reduces the chance of the disease returning in the bowel after surgery. The key difference between the approaches is how the surrounding connective tissue (mesentery) is managed. **You may be eligible if...** - You have a confirmed diagnosis of Crohn's disease - You need surgery to remove the ileocecal region - The disease affects only the end of the small intestine and cecum, with total length less than 80 cm - There is no active disease in the 50 cm above the point where the bowel will be joined after surgery - You are willing to return for follow-up examinations **You may NOT be eligible if...** - You have had previous ileocecal removal surgery - You have active disease in other parts of the bowel requiring separate surgery - You are at risk of short bowel syndrome - You require a stoma (ileostomy) - You have severe anal or rectal disease - You have had a heart attack, unstable angina, or heart failure in the past 6 months - You have a history of cancer (excluding localized skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREmesentery-guided resection margin

Mesentery-guided resection margin where the mesentery adjacent to the intestine completely transitions from abnormal to normal upon palpation and transillumination, compared to the proximal normal mesentery. Open, laparoscopic, hand-assisted, or robotic mobilization are all acceptable, but extracorporeal resection and anastomosis are required. After intestinal mobilization , the diseased intestinal segment is exteriorized from the abdominal cavity.

PROCEDUREtraditional resection margin

2 cm proximal to the site where gross lesions disappear. After transecting the bowel, re-examine the mucosal condition; if mucosal ulcers or obvious scars are present, extend the incision until reaching the site with normal mucosa. Definition of gross lesions: Evaluation from the outer intestinal wall: The site where the tough texture, thickening, or contracture at the mesenteric edge of the intestinal wall disappears; evaluation from the intestinal lumen: The site where mucosal ulcers, fissures, or obvious scars disappear. "Mucosa appearing seemingly abnormal" is considered normal.


Locations(1)

Jia Ke

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06241170