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Completed

NCT Number: NCT01740011

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

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.

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Key information

Conditions

Colorectal Disorders Hernia Incidence for Cholecystectomy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus der Barmherzigen Schwestern Linz

Linz, Upper Austria, 4010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic surgery

Procedure

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Registry information

Official study title

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

Acronym: AirSeal

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2012
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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