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

Krankenhaus Barmherzige Schwestern Linz

Status: Completed

Conditions: Colorectal Disorders; Hernia; Incidence for Cholecystectomy

Treatments: Procedure: Laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01740011

AT-1112-RL

Details and patient eligibility

About

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Group A

Experimental group

Description:

Laparoscopic surgery with AirSeal CO2 pressure insufflation

Treatment:

Procedure: Laparoscopic surgery

Group S

Active Comparator group

Description:

Laparoscopic surgery with standard CO2 pressure insufflation

Treatment:

Procedure: Laparoscopic surgery