Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT02631967
Status:
UNKNOWN
Last Update Posted:
2017-02-15
First Post:
2015-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease
Sponsor:
Federico II University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SuPREMeCD
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: