Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment

A Single-blind, Randomized Study to Compare Impacts of Intraperitoneal Pressure (8mmHg Versus 12 mmHg) and CO2 Gas (Cool, Dry CO2 Gas Versus Warmed; Humidified Co2 Gas) on Surgical Peritoneal Environment During Laparoscopic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Hysteretctomy With Promontofixation
• Intervention / Treatment: Device: Fisher and Paykel Humidifier (MR860AEU)

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 12mmHg intraperitoneal pressure (cool, dry CO2 gas )(n=20)	Device: Fisher and Paykel Humidifier (MR860AEU); Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
OTHER: 12mmHg intraperitoneal pressure (warmed, humidified CO2 gas)	Device: Fisher and Paykel Humidifier (MR860AEU); Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
OTHER: 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20)	Device: Fisher and Paykel Humidifier (MR860AEU); Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
OTHER: 8mmHg intraperitoneal pressure (warmed, humidified CO2 gas)	Device: Fisher and Paykel Humidifier (MR860AEU); Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Quality of post-operative recovery	at day 1
Post-operative pain	at day 1
Per or post operative complications	at day 1
Intraoperative core temperature	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Revaz Botchorishvili, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (ESTIMATE): June 26, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Gene expression; Peritoneum; Carbon deoxide pneumoperitoneum; Intraperitoneal pressure; Post-operative recovery; Laparoscopic Humidification System
• Other Study ID Numbers: CHU-0158