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Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

This study is currently recruiting participants.
Verified October 2011 by Scientific Institute San Raffaele
Sponsor:
Information provided by (Responsible Party):
Andrea Vignali, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier:
NCT01453556
First received: October 13, 2011
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  Purpose

Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.


Condition Intervention
Neoplastic or Benign Disease of Right Colon
Elective Laparoscopic Surgery
 Procedure: Laparoscopic right colectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial

Further study details as provided by Scientific Institute San Raffaele:

Primary Outcome Measures:
  • Post-operative canalisation time and length of stay [ Time Frame: Post-operative stay (about 7 days) ] [ Designated as safety issue: No ]
    Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups


Secondary Outcome Measures:
  • Impact of post-operative ileum and complications. Valuation of global costs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Comparison of post-operative short and long-term complications (in particular post-operative ileum) between the two study groups. Valuation of global costs differences.


Estimated Enrollment: 158
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intracorpopreal anastomosis
Intracorporeal mechanical anastomosis
 Procedure: Laparoscopic right colectomy
Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L
Active Comparator: Extracorporeal anastomosis
Extracorporeal mechanical anastomosis
 Procedure: Laparoscopic right colectomy
Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or more
  • Benign o neoplastic disease of right colon
  • Elective laparoscopic surgery

Exclusion Criteria:

  • Emergency surgery
  • Adhesion or infiltration of near organs
  • Severe heart disease ( New York Heart Association class > 3 )
  • Severe respiratory disease ( arterial PO2 < 70 torr )
  • Severe Liver disease (Child-Pugh class C)
  • Ongoing infections
  • Number of plasmatic neutrophil < a 2.0 x 10 9/L
  • Other contraindications to laparoscopy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453556

Contacts
Contact: Andrea Vignali, MD 0339 02 2643 2272 maxbisso@gmail.com

Locations
Italy
San Raffaele Scientific Institute Recruiting
Milan, MI, Italy, 20132
Contact     0039 02 2643 2272     maxbisso@gmail.com    
Principal Investigator: Andrea Vignali, MD            
Sub-Investigator: Massimiliano Bissolati, MD            
Sponsors and Collaborators
Scientific Institute San Raffaele
Investigators
Principal Investigator: Andrea Vignali, MD San Raffaele Scientific Institute
Study Director: Carlo Staudacher, Prof San Raffaele Scientific Institute
  More Information

No publications provided

Responsible Party: Andrea Vignali, Principal Investigator, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier: NCT01453556     History of Changes
Other Study ID Numbers: Intraextra01
Study First Received: October 13, 2011
Last Updated: October 20, 2011
Health Authority: Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Scientific Institute San Raffaele:
Laparoscopic surgery
Right colectomy
Mechanical anastomosis
Post-operative ileum

ClinicalTrials.gov processed this record on June 18, 2013