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Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Not Applicable
Conditions
Neoplastic or Benign Disease of Right Colon
Elective Laparoscopic Surgery
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

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
Primary Outcome Measures
NameTimeMethod
Post-operative canalisation time and length of stayPost-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
NameTimeMethod
Impact of post-operative ileum and complications. Valuation of global costs12 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

San Raffaele Scientific Institute
🇮🇹Milan, MI, Italy
Andrea Vignali, MD
Principal Investigator
Massimiliano Bissolati, MD
Sub Investigator

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