Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease (SuPREMeCD)

Federico II University

Status: Unknown

Conditions: Crohn Disease

Treatments: Procedure: Kono anastomosis; Procedure: Stapled side-to-side anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02631967

211/15

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Kono anastomosis

Experimental group

Description:

Patients receiving Kono anastomosis

Treatment:

Procedure: Kono anastomosis

Stapled side-to-side anastomosis

Experimental group

Description:

Patients receiving stapled side-to-side anastomosis

Treatment:

Procedure: Stapled side-to-side anastomosis