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CO2 Absorption During Laparoscopy

NCT ID: NCT01340989

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumoperitoneum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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4% oxygen

addition of 4% oxygen to the CO2 pneumoperitoneum

Group Type EXPERIMENTAL

alteration of the insufflation gas

Intervention Type PROCEDURE

addition of 4% oxygen

full conditioning

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

Group Type EXPERIMENTAL

full conditioning

Intervention Type PROCEDURE

addition of 4% oxygen + 10% nitrous oxide to the peritoneum

* humidification
* set temperature of 32°C

CO2 pneumoperitoneum

standard laparoscopy with CO2 pneumoperitoneum

Group Type ACTIVE_COMPARATOR

standard pneumoperitoneum

Intervention Type PROCEDURE

no intervention besides the use of CO2

Interventions

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alteration of the insufflation gas

addition of 4% oxygen

Intervention Type PROCEDURE

full conditioning

addition of 4% oxygen + 10% nitrous oxide to the peritoneum

* humidification
* set temperature of 32°C

Intervention Type PROCEDURE

standard pneumoperitoneum

no intervention besides the use of CO2

Intervention Type PROCEDURE

Eligibility Criteria

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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…)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Responsible Party

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Jasper Verguts

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven, campus Gasthuisberg

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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s52645

Identifier Type: -

Identifier Source: org_study_id