Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Overview

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.

Full Title of Study: “Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2013

Interventions

  • Procedure: Laparoscopic right colectomy
    • Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L

Arms, Groups and Cohorts

  • Experimental: Intracorpopreal anastomosis
    • Intracorporeal mechanical anastomosis
  • Active Comparator: Extracorporeal anastomosis
    • Extracorporeal mechanical anastomosis

Clinical Trial Outcome Measures

Primary Measures

  • Post-operative canalisation time and length of stay
    • Time Frame: Post-operative stay (about 7 days)
    • Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups

Secondary Measures

  • Impact of post-operative ileum and complications. Valuation of global costs
    • Time Frame: 12 months
    • Comparison of post-operative short and long-term complications (in particular post-operative ileum) between the two study groups. Valuation of global costs differences.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Scientific Institute San Raffaele
    • Provider of Information About this Clinical Study
      • Principal Investigator: Andrea Vignali, Principal Investigator – Scientific Institute San Raffaele
    • Overall Official(s)
      • Andrea Vignali, MD, Principal Investigator, San Raffaele Scientific Institute
      • Carlo Staudacher, Prof, Study Director, San Raffaele Scientific Institute
    • Overall Contact(s)
      • Andrea Vignali, MD, 0339 02 2643 2272, maxbisso@gmail.com

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