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

Primary Purpose

Colorectal Disorders, Hernia, Incidence for Cholecystectomy

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Laparoscopic surgery

About this trial

This is an interventional treatment trial for Colorectal Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Krankenhaus der Barmherzigen Schwestern Linz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group S

Arm Description

Laparoscopic surgery with AirSeal CO2 pressure insufflation

Laparoscopic surgery with standard CO2 pressure insufflation

Outcomes

Primary Outcome Measures

time of surgery

Time of surgery, expressed in minutes from the time of incising to suturing the skin.

shoulder pain

Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).

Secondary Outcome Measures

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.

postoperative complications

Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism

Full Information

NCT ID

NCT01740011

First Posted

November 23, 2012

Last Updated

September 5, 2014

Sponsor

Krankenhaus Barmherzige Schwestern Linz

1. Study Identification

Unique Protocol Identification Number

NCT01740011

Brief Title

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

Acronym

AirSeal

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Krankenhaus Barmherzige Schwestern Linz

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Disorders, Hernia, Incidence for Cholecystectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Laparoscopic surgery with AirSeal CO2 pressure insufflation

Arm Title

Group S

Arm Type

Active Comparator

Arm Description

Laparoscopic surgery with standard CO2 pressure insufflation

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic surgery

Primary Outcome Measure Information:

Title

time of surgery

Description

Time of surgery, expressed in minutes from the time of incising to suturing the skin.

Time Frame

one year

Title

shoulder pain

Description

Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).

Time Frame

one year

Secondary Outcome Measure Information:

Title

Immunological aspects

Description

Time Frame

one year

Title

postoperative complications

Description

Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism

Time Frame

one year

Other Pre-specified Outcome Measures:

Title

Anaesthesiological aspects

Description

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.

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruzica-Rosalia Luketina, MD

Organizational Affiliation

Krankenhaus Barmherzige Schwestern Linz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Krankenhaus der Barmherzigen Schwestern Linz

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4010

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

34779236

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.

Results Reference

derived

PubMed Identifier

32767145

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.

Results Reference

derived

PubMed Identifier

24950720

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.

Results Reference

derived

Links:

URL

http://www.bhs.at

Description

Investigator related informations

Learn more about this trial

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

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