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

Crohn Disease Clinical Trial

— SuPREMeCD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631967
• Other study ID #: 211/15
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2015
• Last updated: February 13, 2017
• Start date: November 2015
• Est. completion date: November 2022

Study information

• Verified date: February 2017
• Source: Federico II University
• Contact: Luigi Bucci, Prof
• Phone: 00390817462850
• Email: luigi.bucci[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: November 2022
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Procedure:
• Kono anastomosis
Kono anastomosis
• Stapled side-to-side anastomosis
Stapled side-to-side anastomosis

Locations

Country	Name	City	State
Italy	UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of endoscopic recurrence	Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.	6 Months
Primary	Surgical recurrence	Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery	Up to 5 years
Secondary	Endoscopic recurrence	Presence of endoscopic recurrence	6 months up to 5 years
Secondary	Grade of endoscopic recurrence	Severity of endoscopic recurrence at the site of anastomosis	6 months up to 5 years
Secondary	Clinical recurrence	Presence of clinical recurrence (according to Crohn's disease activity index)	Up to 5 years
Secondary	Operating time	Duration of the operation (min)	Intraoperatively
Secondary	Anastomosis time	Time (min) required to perform the anastomosis	Intraoperatively
Secondary	Anastomotic leak	Incidence of anastomotic leak	Up to 30 days
Secondary	Surgical re-intervention	Rate of patients requiring surgical re-intervention	Up to 30 days
Secondary	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	Up to 30 days
Secondary	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	Participants will be followed for the duration of hospital stay, an expected average of 5 days