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

Hernia Clinical Trial

— AirSeal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740011
• Other study ID #: AT-1112-RL
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: September 5, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: January 2014
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Disorders
• Hernia
• Incidence for Cholecystectomy
• Pneumoperitoneum

Intervention

Procedure:
• Laparoscopic surgery

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Schwestern Linz	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anaesthesiological aspects	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.	one year	No
Primary	time of surgery	Time of surgery, expressed in minutes from the time of incising to suturing the skin.	one year	No
Primary	shoulder pain	Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).	one year	No
Secondary	Immunological aspects	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.	one year	No
Secondary	postoperative complications	Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism	one year	No

External Links

•   Investigator related informations