The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.
Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Standard procedure for CD
handsewn end-to-end or Kono-s anastomosis
Flevoziekenhuis
Almere Stad, Flevoland, Netherlands
RECRUITINGPostoperative endoscopic recurrence at 6 months
The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts \> i2b by central reading
Time frame: 6 months
Post-operative 30 days complications
Time frame: 30 days after surgery
Histologic and clinical recurrence rate at 6 months following ileocolic resection
Time frame: 6 months after surgery
Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
* Endoscopic recurrence defined as Rutgeerts \> i2b * Clinical recurrence difned as recurrent CD-related symptoms
Time frame: 1 year after surgery
The 5 year reoperation rate for recurrence of disease at the anastomotic site.
Time frame: 5 year
Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life measured with IBD questionnaire
Time frame: 1 year after surgery
Hospital costs
Hospital costs per patients in each group
Time frame: 1 year after surgery
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