Comparing hand-sewn and stapled methods for ileocolic surgery in Crohn's disease
Optimising Surgical Anastomosis in Ileocolic Resection for Crohn's Disease to Reduce Recurrent Disease: A Randomised Controlled Trial Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis (END-to-END Study)
NA · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05578235
This study is testing whether hand-sewn or stapled methods for surgery can lead to better recovery and fewer flare-ups in patients with Crohn's disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Almere Stad, Flevoland) |
| Trial ID | NCT05578235 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to compare hand-sewn (end-to-end and Kono-S) anastomosis with stapled side-to-side anastomosis following ileocolic resection in patients with Crohn's disease. The study will evaluate the endoscopic recurrence of the disease, functional outcomes, and healthcare consumption over a period of six months. By analyzing different surgical techniques, the trial seeks to determine which method may lead to better patient outcomes and reduced recurrence rates.
Who should consider this trial
Good fit: Ideal candidates include males and females over 16 years old with ileocolic disease requiring surgical resection.
Not a fit: Patients with significant medical conditions or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that reduce the recurrence of Crohn's disease after surgery.
How similar studies have performed: Previous studies have explored various surgical techniques for Crohn's disease, but this specific comparison of hand-sewn versus stapled anastomosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females aged \>16 years * Ileocolic disease or disease of the neoterminal ileum with an indication for resection * Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted. * All patients should have undergone a colonoscopy and a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))- Ability to comply with protocol. * Competent and able to provide written informed consent. * Patient must have been discussed in the local MDT Exclusion Criteria: * Inability to give informed consent. * Patients less than 16 years of age. * Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. * History of cancer \< 5 years which might influence patients prognosis * Emergent operation. * Pregnant or breast feeding. * Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
Where this trial is running
Almere Stad, Flevoland
- Flevoziekenhuis — Almere Stad, Flevoland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: W.A. Bemelman, Prof. dr. — Amsterdam UMC, location AMC
- Study coordinator: Anouck EG Haanappel, MD
- Email: a.e.g.haanappel@amsterdamumc.nl
- Phone: 0031650828323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, Crohn's disease, Ileocolic, Endoscopic Recurrence, Ileocolic Anastomosis