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

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

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.

Study Overview

• Status: Completed
• Conditions: Hernia; Colorectal Disorders; Incidence for Cholecystectomy
• Intervention / Treatment: Procedure: Laparoscopic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Krankenhaus Der Barmherzigen Schwestern Linz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Laparoscopic surgery with AirSeal CO2 pressure insufflation	Procedure: Laparoscopic surgery
Active Comparator: Group S; Laparoscopic surgery with standard CO2 pressure insufflation	Procedure: Laparoscopic surgery

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anaesthesiological aspects	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.	one year

Collaborators and Investigators

• Sponsor: Krankenhaus Barmherzige Schwestern Linz
• Investigators: Principal Investigator: Ruzica-Rosalia Luketina, MD, Krankenhaus Barmherzige Schwestern Linz

Publications and helpful links

General Publications

• Gallioli A, De Lorenzis E, Lievore E, Boeri L, Colombo L, Fontana M, Breda A, Montanari E, Albo G. The Effect of CO2 Pressure and Flow Variation on Carbon Particles Spread During Pneumoperitoneum: An Experimental Study. J Endourol. 2022 Jun;36(6):807-813. doi: 10.1089/end.2021.0336. Epub 2022 May 17.
• Luketina R, Luketina TLH, Antoniou SA, Kohler G, Konneker S, Manzenreiter L, Wundsam H, Koch OO, Knauer M, Emmanuel K. Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal(R). Surg Endosc. 2021 Jul;35(7):3670-3678. doi: 10.1007/s00464-020-07846-4. Epub 2020 Aug 7.
• Luketina RR, Knauer M, Kohler G, Koch OO, Strasser K, Egger M, Emmanuel K. Comparison of a standard CO(2) pressure pneumoperitoneum insufflator versus AirSeal: study protocol of a randomized controlled trial. Trials. 2014 Jun 20;15:239. doi: 10.1186/1745-6215-15-239.

Helpful Links

• Investigator related informations

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 23, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: AT-1112-RL