A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Disorders
- Sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- time of surgery
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients recruited for laparoscopic surgery i.e. cholecystectomy, colorectal surgery, hernia repair
- •Written informed consent
- •≥ 18 years of age
Exclusion Criteria
- •Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction
- •≤18 years of age
- •Pregnancy and lactation
- •Previous extensive abdominal surgery
- •Acute surgical intervention
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- postoperative complications(one year)
- Immunological aspects(one year)