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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