CO2 Absorption During Laparoscopy

University Hospital, Gasthuisberg

Status: Completed

Conditions: Pneumoperitoneum

Treatments: Procedure: alteration of the insufflation gas; Procedure: standard pneumoperitoneum; Procedure: full conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01340989

s52645

Details and patient eligibility

About

CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures. Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion through prevention of mesothelial hypoxia. We want to prove this concept in human and expand it to the use of full conditioning.

Full description

In order to confirm the animal data in the human, a first RCT was performed in which 20 women undergoing a laparoscopy for at least 60 minutes were randomised to a pneumoperitoneum with either 100% carbon dioxide or 96% carbon dioxide plus 4% of oxygen. Insufflation pressure and Trendelenburg were standardised at 15 mm Hg and 30° respectively. In a second trial women were randomized to either 100% carbon dioxide or 86% carbon dioxide plus 4% of oxygen + 10% nitrous oxide + humidification and set temperature of 32°C of the peritoneal cavity.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women/men planned to undergo a laparoscopic intervention for at least 1 hour and having signed the informed consent

Exclusion criteria

• Pregnancy
• Immunodeficiency
• Refuse or unable to sign informed consent
• Chronic disease (i.e. COPD, Crohn, cardiac...)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

4% oxygen

Experimental group

Description:

addition of 4% oxygen to the CO2 pneumoperitoneum

Treatment:

Procedure: alteration of the insufflation gas

full conditioning

Experimental group

Description:

full conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C

Treatment:

Procedure: full conditioning

CO2 pneumoperitoneum

Active Comparator group

Description:

standard laparoscopy with CO2 pneumoperitoneum

Treatment:

Procedure: standard pneumoperitoneum