NCT01740011

Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal

A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Krankenhaus Barmherzige Schwestern Linz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal® compared with standard pressure CO2 insufflation systems. The primary hypothesis is that patients operated with AirSeal® have a shorter mean operative time and decreased frequency and intensity of postoperative shoulder tip pain compared with patients undergoing surgery with standard pressure CO2 insufflation systems. It is the secondary objective of the trial to evaluate immunologic and anaesthesiological aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by observing the immune responses and volume of mechanical ventilation of the two groups through measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical side effects will also be measured as secondary objective.

Conditions

• Colorectal Disorders
• Hernia
• Incidence for Cholecystectomy

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic surgery

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-12-04
• Last updated: 2014-09-08

Locations

1 site across 1 country: Austria