Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Elective Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01453556
• Other study ID #: Intraextra01
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2011
• Last updated: October 20, 2011
• Start date: October 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2011
• Source: Scientific Institute San Raffaele
• Contact: Andrea Vignali, MD
• Phone: 0339 02 2643 2272
• Email: maxbisso[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elective Laparoscopic Surgery
• Neoplastic or Benign Disease of Right Colon

Intervention

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

Locations

Country	Name	City	State
Italy	San Raffaele Scientific Institute	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	Yes