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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

Tracking Information
First Submitted Date  ICMJE November 29, 2015
First Posted Date  ICMJE December 16, 2015
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease
Official Title  ICMJE A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Procedure: Kono anastomosis
    Kono anastomosis
  • Procedure: Stapled side-to-side anastomosis
    Stapled side-to-side anastomosis
Study Arms  ICMJE
  • Experimental: Kono anastomosis
    Patients receiving Kono anastomosis
    Intervention: Procedure: Kono anastomosis
  • Experimental: Stapled side-to-side anastomosis
    Patients receiving stapled side-to-side anastomosis
    Intervention: Procedure: Stapled side-to-side anastomosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 15, 2015)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luigi Bucci, Prof 00390817462850 luigi.bucci@unina.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02631967
Other Study ID Numbers  ICMJE 211/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luigi Bucci, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luigi Bucci, Prof Federico II University of Naples
PRS Account Federico II University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP