Clinical trial NCT02631967: Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease
Official title: A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn disease
ileocecal resection
anastomosis
Kono
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with Crohn's disease requiring ileocecal resection

Exclusion Criteria:

* age \> 75 years
* age \< 18 years
* inability to give the consent to the participation in the trial
* refusal to participate in the trial after receiving accurate information

Primary outcomes:
measure: Grade of endoscopic recurrence
timeFrame: 6 Months
measure: Surgical recurrence
timeFrame: Up to 5 years
Secondary outcomes:
measure: Endoscopic recurrence
timeFrame: 6 months up to 5 years
measure: Grade of endoscopic recurrence
timeFrame: 6 months up to 5 years
measure: Clinical recurrence
timeFrame: Up to 5 years
measure: Operating time
timeFrame: Intraoperatively
measure: Anastomosis time
timeFrame: Intraoperatively
measure: Anastomotic leak
timeFrame: Up to 30 days
measure: Surgical re-intervention
timeFrame: Up to 30 days
measure: Postoperative morbidity rate
timeFrame: Up to 30 days
measure: Recovery times
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II
Study officials:
affiliation: Federico II University of Naples
name: Luigi Bucci, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.
citation: Luglio G, Rispo A, Imperatore N, Giglio MC, Amendola A, Tropeano FP, Peltrini R, Castiglione F, De Palma GD, Bucci L. Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial. Ann Surg. 2020 Aug;272(2):210-217. doi: 10.1097/SLA.0000000000003821.