Clinical trial NCT05246917: Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease
Official title: Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
IBD
Ileocolitis
Crohn's Ileocolitis
Keywords: Recurrence IBD
IBD
Endoscopic Recurrence
Rurgeers Score
Surgical recurrence
Crohn's Ileocolitis
Ileocolic Anastomosis
Crohn's disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised superiority study
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification.
timeFrame: 6 months
Secondary outcomes:
measure: Morbidity
timeFrame: 1 year
measure: Clinical Recurrence
timeFrame: 1 year
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: 1 year
measure: Hospital Costs
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: irccs San Raffaele
Study officials:
References: