Comparing surgical methods to reduce recurrence in Crohn's disease after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate different surgical approaches for patients with Crohn's disease undergoing ileocolic resection, focusing on the impact of mesentery-guided resection on reducing endoscopic recurrence rates. The study will include patients diagnosed with localized ileocecal Crohn's disease and will assess the effectiveness of the surgical technique in preventing postoperative complications. By analyzing the correlation between mesenteric wrapping and recurrence, the trial seeks to provide insights into optimizing surgical outcomes for Crohn's disease patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jia Ke
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jia Ke, M.D. — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Jun H, M.D.
• Email: hujun33@mail.sysu.edu.cn
• Phone: 13535452363

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.