Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Scientific Institute San Raffaele.
Recruitment status was  Recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014