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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients with a clear diagnosis of CD who meet the surgical indications and will undergo one-stage ileocecal resection,

• Ileocecal CD with localized lesions involving the terminal ileum and cecum, with a total lesion length of \<80 cm,

• No residual lesions within 50 cm proximal to the ileocecal anastomosis,

• Patients or their legal guardians who can understand and are willing to participate in this study, provide written informed consent, and have the ability to comply with the protocol.

Locations
Other Locations
China
Jia Ke
RECRUITING
Guangzhou
Contact Information
Primary
Jun H, M.D.
hujun33@mail.sysu.edu.cn
13535452363
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 172
Treatments
Experimental: mesentery-guided resection margin group
Patients will undergo surgery using the mesentery-guided resection margin approach.
Active_comparator: traditional resection margin group
Patients will undergo surgery using the traditional resection margin approach.
Related Therapeutic Areas
Sponsors
Collaborators: Jinling Hospital, China, Zhongnan Hospital, Sir Run Run Shaw Hospital
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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