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

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ClinicalTrials.gov Identifier: NCT01740011
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Colorectal Disorders Hernia Incidence for Cholecystectomy Procedure: Laparoscopic surgery

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
Study Start Date : January 2013
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. time of surgery [ Time Frame: one year ]
    Time of surgery, expressed in minutes from the time of incising to suturing the skin.

  2. shoulder pain [ Time Frame: one year ]
    Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).


Secondary Outcome Measures :
  1. Immunological aspects [ Time Frame: 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.

  2. postoperative complications [ Time Frame: one year ]
    Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism


Other Outcome Measures:
  1. Anaesthesiological aspects [ Time Frame: one year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740011


Locations
Austria
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Upper Austria, Austria, 4010
Sponsors and Collaborators
Krankenhaus Barmherzige Schwestern Linz
Investigators
Principal Investigator: Ruzica-Rosalia Luketina, MD Krankenhaus Barmherzige Schwestern Linz

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT01740011     History of Changes
Other Study ID Numbers: AT-1112-RL
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases