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

This study is currently recruiting participants.
Verified January 2014 by Krankenhaus Barmherzige Schwestern Linz
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier:
NCT01740011
First received: November 23, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention
Colorectal Disorders
Hernia
Incidence for Cholecystectomy
Procedure: Laparoscopic surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal

Resource links provided by NLM:


Further study details as provided by Krankenhaus Barmherzige Schwestern Linz:

Primary Outcome Measures:
  • time of surgery [ Time Frame: one year ] [ Designated as safety issue: No ]
    Time of surgery, expressed in minutes from the time of incising to suturing the skin.

  • shoulder pain [ Time Frame: one year ] [ Designated as safety issue: No ]
    Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).


Secondary Outcome Measures:
  • Immunological aspects [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism


Other Outcome Measures:
  • Anaesthesiological aspects [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 182
Study Start Date: January 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740011

Contacts
Contact: Ruzica-Rosalia Luketina, MD +43 73276777300 ruzica-rosalia.luketina@bhs.at
Contact: Klaus Emmanuel, MD, Prof. +43 73276777300 klaus.emmanuel@bhs.at

Locations
Austria
Krankenhaus der Barmherzigen Schwestern Linz Recruiting
Linz, Upper Austria, Austria, 4010
Contact: Ruzica-Rosalia Luketina, MD       ruzica-rosalia.luketina@bhs.at   
Sponsors and Collaborators
Krankenhaus Barmherzige Schwestern Linz
Investigators
Principal Investigator: Ruzica-Rosalia Luketina, MD Krankenhaus Barmherzige Schwestern Linz
  More Information

Additional Information:
No publications provided

Responsible Party: Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT01740011     History of Changes
Other Study ID Numbers: AT-1112-RL
Study First Received: November 23, 2012
Last Updated: January 28, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Hernia
Pneumoperitoneum
Pathological Conditions, Anatomical
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014