Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Neoplastic or Benign Disease of Right Colon; Elective Laparoscopic Surgery
• Intervention / Treatment: Procedure: Laparoscopic right colectomy

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Recruiting
      • San Raffaele Scientific Institute
      • Contact: Phone Number: 0039 02 2643 2272; Email: maxbisso@gmail.com
      • Principal Investigator: Andrea Vignali, MD
      • Sub-Investigator: Massimiliano Bissolati, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele
• Investigators: Principal Investigator: Andrea Vignali, MD, San Raffaele Scientific Institute; Study Director: Carlo Staudacher, Prof, San Raffaele Scientific Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 21, 2011
• Last Update Submitted That Met QC Criteria: October 20, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Right colectomy; Mechanical anastomosis; Post-operative ileum
• Other Study ID Numbers: Intraextra01