Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Scientific Institute San Raffaele

Status: Unknown

Conditions: Elective Laparoscopic Surgery; Neoplastic or Benign Disease of Right Colon

Treatments: Procedure: Laparoscopic right colectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01453556

Intraextra01

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Intracorpopreal anastomosis

Experimental group

Description:

Intracorporeal mechanical anastomosis

Treatment:

Procedure: Laparoscopic right colectomy

Extracorporeal anastomosis

Active Comparator group

Description:

Extracorporeal mechanical anastomosis

Treatment:

Procedure: Laparoscopic right colectomy