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