CO2 Absorption During Laparoscopy

NCT01340989 | Completed

• 1 other identifier: s52645
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumoperitoneum

Keywords

women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas

Outcome Measures

Primary Outcomes (1)

• CO2 absorption

  Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)

  measurements for 60 to 240 minutes on average during surgery

Secondary Outcomes (1)

• hemodynamic alterations

  measurements for 60 to 240 minutes on average during surgery

Study Arms (3)

4% oxygen

EXPERIMENTAL

addition of 4% oxygen to the CO2 pneumoperitoneum

Procedure: alteration of the insufflation gas

full conditioning

EXPERIMENTAL

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

Procedure: full conditioning

CO2 pneumoperitoneum

ACTIVE COMPARATOR

standard laparoscopy with CO2 pneumoperitoneum

Procedure: standard pneumoperitoneum

Interventions

alteration of the insufflation gas PROCEDURE

addition of 4% oxygen

4% oxygen

full conditioning PROCEDURE

addition of 4% oxygen + 10% nitrous oxide to the peritoneum * humidification * set temperature of 32°C

full conditioning

standard pneumoperitoneum PROCEDURE

no intervention besides the use of CO2

CO2 pneumoperitoneum

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (1)

UZ Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Pneumoperitoneum; Endometriosis; Tissue Adhesions; Myoma

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 25, 2011
• Study Start: August 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 26, 2011

Record last verified: 2011-10

Locations

BE (1)