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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Disorders, Hernia, Incidence for Cholecystectomy

Intervention / Treatment
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* Procedure: Laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Laparoscopic surgery with AirSeal CO2 pressure insufflation | Procedure: Laparoscopic surgery<br> <br> |
| Active Comparator: Group S<br>Laparoscopic surgery with standard CO2 pressure insufflation | Procedure: Laparoscopic surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of surgery | Time of surgery, expressed in minutes from the time of incising to suturing the skin. | one year | 
| shoulder pain | Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale). | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological aspects | 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. | one year | 
| postoperative complications | Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism | one year |