Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal (AirSeal)
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|ClinicalTrials.gov Identifier: NCT01740011|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : September 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Disorders Hernia Incidence for Cholecystectomy||Procedure: Laparoscopic surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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|
- 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).
- 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
- Anaesthesiological aspects [ Time Frame: one year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740011
|Krankenhaus der Barmherzigen Schwestern Linz|
|Linz, Upper Austria, Austria, 4010|
|Principal Investigator:||Ruzica-Rosalia Luketina, MD||Krankenhaus Barmherzige Schwestern Linz|