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

NCT01740011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2014-09-08

No results posted yet for this study

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.

Conditions

  • Colorectal Disorders
  • Hernia
  • Incidence for Cholecystectomy

Interventions

PROCEDURE

Laparoscopic surgery

Sponsors & Collaborators

  • Krankenhaus Barmherzige Schwestern Linz

    lead OTHER

Principal Investigators

  • Ruzica-Rosalia Luketina, MD · Krankenhaus Barmherzige Schwestern Linz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01740011 on ClinicalTrials.gov