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

Not Applicable

Completed

• Conditions: Incidence for Cholecystectomy; Colorectal Disorders; Hernia
• Interventions: Procedure: Laparoscopic surgery

• Registration Number: NCT01740011
• Lead Sponsor: Krankenhaus Barmherzige Schwestern Linz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-04
• Study Start: 2013-01
• Status Verified: 2014-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Laparoscopic surgery	Laparoscopic surgery with standard CO2 pressure insufflation
Group A	Laparoscopic surgery	Laparoscopic surgery with AirSeal CO2 pressure insufflation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
postoperative complications	one year	Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism
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.

Trial Locations

Locations (1)

Krankenhaus der Barmherzigen Schwestern Linz; 🇦🇹 Linz, Upper Austria, Austria