Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD). This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis. In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery. Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Kono anastomosis
Stapled side-to-side anastomosis
UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II
Napoli, Italy
RECRUITINGGrade of endoscopic recurrence
Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
Time frame: 6 Months
Surgical recurrence
Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery
Time frame: Up to 5 years
Endoscopic recurrence
Presence of endoscopic recurrence
Time frame: 6 months up to 5 years
Grade of endoscopic recurrence
Severity of endoscopic recurrence at the site of anastomosis
Time frame: 6 months up to 5 years
Clinical recurrence
Presence of clinical recurrence (according to Crohn's disease activity index)
Time frame: Up to 5 years
Operating time
Duration of the operation (min)
Time frame: Intraoperatively
Anastomosis time
Time (min) required to perform the anastomosis
Time frame: Intraoperatively
Anastomotic leak
Incidence of anastomotic leak
Time frame: Up to 30 days
Surgical re-intervention
Rate of patients requiring surgical re-intervention
Time frame: Up to 30 days
Postoperative morbidity rate
Postoperative surgical (bleeding, obstruction, postoperative ileus, abdominal collection, wound infection) and medical morbidity as well as mortality will be documented and graded according to the Dindo Clavien classification
Time frame: Up to 30 days
Recovery times
Length of post-operative hospital stay, time to first flatus, time to first defecation, time to tolerance of liquid and solid diet will be documented
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
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