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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

Tracking Information
First Submitted Date  ICMJE November 23, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date September 8, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • time of surgery [ Time Frame: one year ]
    Time of surgery, expressed in minutes from the time of incising to suturing the skin.
  • shoulder pain [ Time Frame: one year ]
    Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • 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.
  • postoperative complications [ Time Frame: one year ]
    Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 29, 2012)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
Official Title  ICMJE A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Disorders
  • Hernia
  • Incidence for Cholecystectomy
Intervention  ICMJE Procedure: Laparoscopic surgery
Study Arms  ICMJE
  • Experimental: Group A
    Laparoscopic surgery with AirSeal CO2 pressure insufflation
    Intervention: Procedure: Laparoscopic surgery
  • Active Comparator: Group S
    Laparoscopic surgery with standard CO2 pressure insufflation
    Intervention: Procedure: Laparoscopic surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 29, 2012)
182
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740011
Other Study ID Numbers  ICMJE AT-1112-RL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Krankenhaus Barmherzige Schwestern Linz
Study Sponsor  ICMJE Krankenhaus Barmherzige Schwestern Linz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruzica-Rosalia Luketina, MD Krankenhaus Barmherzige Schwestern Linz
PRS Account Krankenhaus Barmherzige Schwestern Linz
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP