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

Not Applicable

• Conditions: Crohn Disease
• Interventions: Procedure: Stapled side-to-side anastomosis; Procedure: Kono anastomosis

• Registration Number: NCT02631967
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-29
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-15
• Primary Completion: 2017-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapled side-to-side anastomosis	Stapled side-to-side anastomosis	Patients receiving stapled side-to-side anastomosis
Kono anastomosis	Kono anastomosis	Patients receiving Kono anastomosis

Primary Outcome Measures

Name	Time	Method
Grade of endoscopic recurrence	6 Months	Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
Surgical recurrence	Up to 5 years	Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery

Secondary Outcome Measures

Name	Time	Method
Surgical re-intervention	Up to 30 days	Rate of patients requiring surgical re-intervention
Recovery times	Participants will be followed for the duration of hospital stay, an expected average of 5 days	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
Endoscopic recurrence	6 months up to 5 years	Presence of endoscopic recurrence
Grade of endoscopic recurrence	6 months up to 5 years	Severity of endoscopic recurrence at the site of anastomosis
Anastomotic leak	Up to 30 days	Incidence of anastomotic leak
Postoperative morbidity rate	Up to 30 days	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
Anastomosis time	Intraoperatively	Time (min) required to perform the anastomosis
Clinical recurrence	Up to 5 years	Presence of clinical recurrence (according to Crohn's disease activity index)
Operating time	Intraoperatively	Duration of the operation (min)

Trial Locations

Locations (1)

UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II; 🇮🇹 Napoli, Italy