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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
Sponsor:
Information provided by (Responsible Party):
Luigi Bucci, 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.


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

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 related topics: Crohn's Disease

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




Primary Outcome Measures :
  1. 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.

  2. Surgical recurrence [ Time Frame: Up to 5 years ]
    Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery


Secondary Outcome Measures :
  1. Endoscopic recurrence [ Time Frame: 6 months up to 5 years ]
    Presence of endoscopic recurrence

  2. Grade of endoscopic recurrence [ Time Frame: 6 months up to 5 years ]
    Severity of endoscopic recurrence at the site of anastomosis

  3. Clinical recurrence [ Time Frame: Up to 5 years ]
    Presence of clinical recurrence (according to Crohn's disease activity index)

  4. Operating time [ Time Frame: Intraoperatively ]
    Duration of the operation (min)

  5. Anastomosis time [ Time Frame: Intraoperatively ]
    Time (min) required to perform the anastomosis

  6. Anastomotic leak [ Time Frame: Up to 30 days ]
    Incidence of anastomotic leak

  7. Surgical re-intervention [ Time Frame: Up to 30 days ]
    Rate of patients requiring surgical re-intervention

  8. 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

  9. 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



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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

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

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

Publications:
Responsible Party: Luigi Bucci, Professor, Federico II University
ClinicalTrials.gov Identifier: NCT02631967     History of Changes
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:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases