Clinical trial NCT01740011: Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
Official title: A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Disorders
Hernia
Incidence for Cholecystectomy
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: time of surgery
timeFrame: one year
measure: shoulder pain
timeFrame: one year
Secondary outcomes:
measure: Immunological aspects
timeFrame: one year
measure: postoperative complications
timeFrame: one year
Other outcomes:
measure: Anaesthesiological aspects
timeFrame: one year
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz
state: Upper Austria
Study officials:
affiliation: Krankenhaus Barmherzige Schwestern Linz
name: Ruzica-Rosalia Luketina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.