Crohn Disease, Crohn's Ileocolitis, IBD, Ileocolitis
Conditions
Keywords
Recurrence IBD, IBD, Endoscopic Recurrence, Rurgeers Score, Surgical recurrence, Crohn's Ileocolitis, Ileocolic Anastomosis, Crohn's disease
Brief summary
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs. HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction. DESIGN Randomised superiority study POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum INTERVENTION Kono S and end to end hand sewn anastomosis USUAL CARE Side to side stapled anastomosis OUTCOME Endoscopic recurrence (local and central reading) at 6 months SAMPLE 25% reduction in 2:1 ratio -\> 126 + 63 = 189 patients KEYWORDS Crohn, ileocolic resection, recurrence
Interventions
PROCEDUREHandsewn anastomosis
To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomised superiority study
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged \>18 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 MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease. * 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. * Patients undergoing repeated ileocolic resection. * History of cancer \< 5 years which might influence patients prognosis * Emergent operation. Pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification. | 6 months | The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 1 year | postoperative morbidity measure |
| Clinical Recurrence | 1 year | Clinical and surgical recurrence using Clavien Dindo |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | 1 year | Quality of life measured with IBD questionnaire |
| Hospital Costs | 1 year | Hospital costs per patient in both groups |
Countries
Italy
Contacts
Primary Contactvittoria bellato, MD
Outcome results
None listed