Colorectal Disorders, Hernia, Incidence for Cholecystectomy
Conditions
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.
Interventions
PROCEDURELaparoscopic surgery
Sponsors
Krankenhaus Barmherzige Schwestern Linz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time of surgery | one year | Time of surgery, expressed in minutes from the time of incising to suturing the skin. |
| shoulder pain | one year | Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological aspects | 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 | one year | Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anaesthesiological aspects | 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. |
Countries
Austria
Outcome results
None listed