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

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ClinicalTrials.gov Identifier: NCT02631967

Recruitment Status : Recruiting

First Posted : December 16, 2015

Last Update Posted : February 15, 2017

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Luigi Bucci, Federico II University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn Disease	Procedure: Kono anastomosis Procedure: Stapled side-to-side anastomosis	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	132 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	November 2015
Estimated Primary Completion Date :	November 2017
Estimated Study Completion Date :	November 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Kono anastomosis Patients receiving Kono anastomosis	Procedure: Kono anastomosis Kono anastomosis
Experimental: Stapled side-to-side anastomosis Patients receiving stapled side-to-side anastomosis	Procedure: Stapled side-to-side anastomosis Stapled side-to-side anastomosis

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Endoscopic recurrence [ Time Frame: 6 months up to 5 years ]
Presence of endoscopic recurrence
Grade of endoscopic recurrence [ Time Frame: 6 months up to 5 years ]
Severity of endoscopic recurrence at the site of anastomosis
Clinical recurrence [ Time Frame: Up to 5 years ]
Presence of clinical recurrence (according to Crohn's disease activity index)
Operating time [ Time Frame: Intraoperatively ]
Duration of the operation (min)
Anastomosis time [ Time Frame: Intraoperatively ]
Time (min) required to perform the anastomosis
Anastomotic leak [ Time Frame: Up to 30 days ]
Incidence of anastomotic leak
Surgical re-intervention [ Time Frame: Up to 30 days ]
Rate of patients requiring surgical re-intervention
Postoperative morbidity rate [ Time Frame: 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
Recovery times [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631967

Contacts

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Contact: Luigi Bucci, Prof	00390817462850	luigi.bucci@unina.it

Locations

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Italy
UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II	Recruiting
Napoli, Italy, 80121
Contact: Luigi Bucci, Prof 00390817462850 luigi.bucci@unina.it
Sub-Investigator: Mariano Cesare Giglio, Dr
Sub-Investigator: Gaetano Luglio, Dr
Sub-Investigator: Fabiana Castiglione, Prof
Sub-Investigator: Antonio Rispo, Dr
Sub-Investigator: Giovanni Domenico De Palma, Prof

Sponsors and Collaborators

Federico II University

Investigators

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Principal Investigator:	Luigi Bucci, Prof	Federico II University of Naples

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Luigi Bucci, Professor, Federico II University
ClinicalTrials.gov Identifier:	NCT02631967
Other Study ID Numbers:	211/15
First Posted:	December 16, 2015 Key Record Dates
Last Update Posted:	February 15, 2017
Last Verified:	February 2017

Keywords provided by Luigi Bucci, Federico II University:


Crohn disease ileocecal resection anastomosis Kono

Additional relevant MeSH terms:

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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases

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