Crohn'sRecruiting
Mesenteric Surgical Margin for Crohn's Disease Endoscopic Recurrence
Not applicable · Testing mesentery-guided resection margin and traditional resection margin · 1 site · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing mesentery-guided resection margin (a procedure) and traditional resection margin (a procedure) as a possible treatment. Condition(s) listed: Endoscopic Recurrence Rate and After Ileocolic Crohn 's Disease Surgery.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 14 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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,
Plus 1 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 172 participants are expected to take part.
- Start date: 2025-07-01.
- Main results expected around 2028-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- The Modified Rutgeerts Score during colonoscopy (At 6 months after surgery.)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Endoscopic Recurrence Rate; After Ileocolic Crohn 's Disease Surgery |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Collaborators | Jinling Hospital, China; Sir Run Run Shaw Hospital; Zhongnan Hospital |
| Enrollment | 172 (estimated) |
| Start date | 2025-07-01 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2024-02-05 |
| Last updated | 2025-07-15 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06241170 |
Interventions
- mesentery-guided resection margin (Procedure)
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 intestina… - traditional resection margin (Procedure)
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 intes…
Full eligibility criteria (from the record)
Inclusion criteria: 1. Patients with a clear diagnosis of CD who meet the surgical indications and will undergo one-stage ileocecal resection, 2. Ileocecal CD with localized lesions involving the terminal ileum and cecum, with a total lesion length of <80 cm, 3. No residual lesions within 50 cm proximal to the ileocecal anastomosis, 4. 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. Exclusion criteria: 1. Patients with a history of ileocecal resection, 2. Patients with primary lesions in other locations (e.g., proximal small bowel) that require surgical resection of inflamed intestinal segments other than the ileocecal region (excluding cases with affected other segments of the bowel), 3. Patients with a risk of short bowel syndrome, 4. Patients who require ileostomy formation, 5. Patients with severe anorectal lession, 6. Patients predicted to be unable to receive postoperative drug therapy, 7. Patients unable to return to the hospital for re-examination in a timely manner 8. Patients who have suffered from serious illnesses within the six months before surgery, such as myocardial infarction, active angina pectoris, congestive heart failure, or other diseases believed by the investigator to pose a risk to the patient's safety, 9. Patients with a history of malignant tumors, including melanoma (excluding localized skin cancer), 10. Patients clinically diagnosed with autoimmune diseases other than CD or with evidence of other autoimmune diseases. 11. Pregnant or lactating patients. 12. Patients who cannot be tracked at various study time points for the primary outcome measure. Withdrawal criteria: 1. Subjects lost to follow-up or voluntarily requesting withdrawal. 2. The occurrence of anastomotic fistula after surgery that affects subsequent endoscopic evaluation. 3. Subjects considered unsuitable for further participation in the study by the investigator.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Jia Ke | Guangzhou, Guangdong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.