Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment

Not Applicable

Completed

• Conditions: Laparoscopic Hysteretctomy With Promontofixation
• Interventions: Device: Fisher and Paykel Humidifier (MR860AEU)

• Registration Number: NCT01887028
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Use lay language.

The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12 mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum may be better in minimizing adverse effects on surgical peritoneal environment and improving clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard cool, dry CO2 gas.

Detailed Description

Patients undergoing laparoscopic hysterectomy with promontofixation are randomized into four groups: Group 1: 12mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 2: 12mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20), Group 3: 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 4: 8mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20).

Normal peritoneum is collected from the parietal wall at the beginning of laparoscopic surgery and at 1 and 2 hours. Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signaling molecules in peritoneal tissues are measured by real-time PCR.

Quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, per or post operative complications and intraoperative core temperature are assessed and compared.

Study Timeline

• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Study Start: 2013-07
• Primary Completion: 2015-09
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Age 45-75 years old
• Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse
• Menopaused
• ASA class I or II

Exclusion Criteria

• Absolute contraindications to laparoscopy
• Previous history of pelvic surgery, endometriosis and/or infection
• Pathological peritoneal tissue
• BMI more than 30
• Height less than 150cm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20)	Fisher and Paykel Humidifier (MR860AEU)	-
8mmHg intraperitoneal pressure (warmed, humidified CO2 gas)	Fisher and Paykel Humidifier (MR860AEU)	-
12mmHg intraperitoneal pressure (cool, dry CO2 gas )(n=20)	Fisher and Paykel Humidifier (MR860AEU)	-
12mmHg intraperitoneal pressure (warmed, humidified CO2 gas)	Fisher and Paykel Humidifier (MR860AEU)	-

Primary Outcome Measures

Name	Time	Method
Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues	at1 hour and 2 hours (day 1)

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	at day 1
Intraoperative core temperature	at day 1
Quality of post-operative recovery	at day 1
Per or post operative complications	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France