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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01887028

Enrollment

Registered

2013-06-26

Start date

2013-07-31

Completion date

2016-07-31

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Hysteretctomy With Promontofixation

Keywords

Carbon deoxide pneumoperitoneum, Intraperitoneal pressure, Peritoneum, Gene expression, Post-operative recovery, Laparoscopic Humidification System

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.

Interventions

DEVICEFisher 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026