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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Krankenhaus Barmherzige Schwestern Linz

Current Primary Outcome:

• time of surgery [ Time Frame: one year ]
  Time of surgery, expressed in minutes from the time of incising to suturing the skin.
• shoulder pain [ Time Frame: one year ]
  Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Immunological aspects [ Time Frame: one year ]
  Examine changes in the concentration of certain cytokines and angiogenic factors serum levels in the early postoperative period after laparoscopic surgery procedures performed with AirSeal® versus standard- pressure CO2 pneumoperitoneum.
• postoperative complications [ Time Frame: one year ]
  Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism

Original Secondary Outcome: Same as current

Information By: Krankenhaus Barmherzige Schwestern Linz

Dates:
Date Received: November 23, 2012
Date Started: January 2013
Date Completion:
Last Updated: September 5, 2014
Last Verified: January 2014