Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
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.
Incidence for Cholecystectomy
Procedure: Laparoscopic surgery
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal|
- time of surgery [ Time Frame: one year ] [ Designated as safety issue: No ]Time of surgery, expressed in minutes from the time of incising to suturing the skin.
- shoulder pain [ Time Frame: one year ] [ Designated as safety issue: No ]Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).
- Immunological aspects [ Time Frame: one year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism
- Anaesthesiological aspects [ Time Frame: one year ] [ Designated as safety issue: No ]Examine intraoperative changes in ventilation volume, acid-base balance and CO2 elimination in patients undergoing laparoscopic surgery procedures performed with AirSeal® versus standard- pressure CO2 pneumoperitoneum.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Group A
Laparoscopic surgery with AirSeal CO2 pressure insufflation
|Procedure: Laparoscopic surgery|
Active Comparator: Group S
Laparoscopic surgery with standard CO2 pressure insufflation
|Procedure: Laparoscopic surgery|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740011
|Contact: Ruzica-Rosalia Luketina, MD||+43 email@example.com|
|Contact: Klaus Emmanuel, MD, Prof.||+43 firstname.lastname@example.org|
|Krankenhaus der Barmherzigen Schwestern Linz||Recruiting|
|Linz, Upper Austria, Austria, 4010|
|Contact: Ruzica-Rosalia Luketina, MD email@example.com|
|Principal Investigator:||Ruzica-Rosalia Luketina, MD||Krankenhaus Barmherzige Schwestern Linz|