Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Not Applicable

• Conditions: Neoplastic or Benign Disease of Right Colon; Elective Laparoscopic Surgery
• Interventions: Procedure: Laparoscopic right colectomy

• Registration Number: NCT01453556
• Lead Sponsor: Scientific Institute San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Last Update Submitted: 2011-10-20
• Last Update Posted: 2011-10-21
• Primary Completion: 2013-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracorpopreal anastomosis	Laparoscopic right colectomy	Intracorporeal mechanical anastomosis
Extracorporeal anastomosis	Laparoscopic right colectomy	Extracorporeal mechanical anastomosis

Primary Outcome Measures

Name	Time	Method
Post-operative canalisation time and length of stay	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 Outcome Measures

Name	Time	Method
Impact of post-operative ileum and complications. Valuation of global costs	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.

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milan, MI, Italy