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

• Sponsor: Krankenhaus Barmherzige Schwestern Linz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01740011
• Collaborator: (none)
• Enrollment: 182
• Location: 1
• Arms: 2
• Duration (Months): 13.9
• Patients Per Site Per Month: 13.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Disorders; Hernia; Incidence for Cholecystectomy	Procedure: Laparoscopic surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 182 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. time of surgery [one year]

   Time of surgery, expressed in minutes from the time of incising to suturing the skin.

2. shoulder pain [one year]

   Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).

Secondary Outcome Measures

1. Immunological aspects [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 [one year]

   Haemorrhage, Wound infections, Intra-abdominal abscess, Anastomotic leakage, Deep vein thrombosis, Pulmonary embolism

Other Outcome Measures

1. Anaesthesiological aspects [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus der Barmherzigen Schwestern Linz	Linz	Upper Austria	Austria	4010

Sponsors and Collaborators

• Krankenhaus Barmherzige Schwestern Linz

Investigators

• Principal Investigator: Ruzica-Rosalia Luketina, MD, Krankenhaus Barmherzige Schwestern Linz

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Investigator related informations

Publications

None provided.

• Responsible Party: Krankenhaus Barmherzige Schwestern Linz
• ClinicalTrials.gov Identifier: NCT01740011
• Other Study ID Numbers: AT-1112-RL
• First Posted: Dec 4, 2012
• Last Update Posted: Sep 8, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Pneumoperitoneum

Study Results

No Results Posted as of Sep 8, 2014