Laparoscopic Hysteretctomy With PromontofixationNCT01887028
Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment
A study testing Fisher and Paykel Humidifier (MR860AEU) in people with Laparoscopic Hysteretctomy With Promontofixation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Laparoscopic Hysteretctomy With Promontofixation
- What is being tested?
- Fisher and Paykel Humidifier (MR860AEU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-75 years old
- Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse
- Menopaused
- ASA class I or II
Who cannot join
- Absolute contraindications to laparoscopy
- Previous history of pelvic surgery, endometriosis and/or infection
- Pathological peritoneal tissue
- BMI more than 30
- Height less than 150cm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Fisher and Paykel Humidifier (MR860AEU)
- Keywords
- Carbon deoxide pneumoperitoneum, Intraperitoneal pressure, Peritoneum, Gene expression, Post-operative recovery, Laparoscopic Humidification System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisher and Paykel Humidifier (MR860AEU)Device
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 group | Role | What they receive |
|---|---|---|
| 12mmHg intraperitoneal pressure (cool, dry CO2 gas )(n=20) | Experimental | Not described Receives: Device: Fisher and Paykel Humidifier (MR860AEU) |
| 12mmHg intraperitoneal pressure (warmed, humidified CO2 gas) | Other | Not described Receives: Device: Fisher and Paykel Humidifier (MR860AEU) |
| 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20) | Other | Not described Receives: Device: Fisher and Paykel Humidifier (MR860AEU) |
| 8mmHg intraperitoneal pressure (warmed, humidified CO2 gas) | Other | Not described Receives: Device: Fisher and Paykel Humidifier (MR860AEU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues
Measured: at1 hour and 2 hours (day 1)
Secondary outcomes (4)
Quality of post-operative recovery
Measured: at day 1
Post-operative pain
Measured: at day 1
Per or post operative complications
Measured: at day 1
Intraoperative core temperature
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Hysteretctomy With PromontofixationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Revaz BOTCHORISHVILI, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887028
- Sponsor's protocol ID
- CHU-0158
- Status last verified
- Jul 2016
- First submitted
- 24 Jun 2013
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01887028
- Acronym / sponsor ID
- CHU-0158
- Keywords
- Carbon deoxide pneumoperitoneum, Intraperitoneal pressure, Peritoneum, Gene expression, Post-operative recovery, Laparoscopic Humidification System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12mmHg intraperitoneal pressure (cool, dry CO2 gas )(n=20) | Experimental | Device: Fisher and Paykel Humidifier (MR860AEU) |
| 12mmHg intraperitoneal pressure (warmed, humidified CO2 gas) | Other | Device: Fisher and Paykel Humidifier (MR860AEU) |
| 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20) | Other | Device: Fisher and Paykel Humidifier (MR860AEU) |
| 8mmHg intraperitoneal pressure (warmed, humidified CO2 gas) | Other | Device: Fisher and Paykel Humidifier (MR860AEU) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45-75 years old
- Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse
- Menopaused
- ASA class I or II
Key exclusion criteria (5 listed)
- Absolute contraindications to laparoscopy
- Previous history of pelvic surgery, endometriosis and/or infection
- Pathological peritoneal tissue
- BMI more than 30
- Height less than 150cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | 12mmHg intraperitoneal pressure (cool, dry CO2 gas )(n=20), 12mmHg intraperitoneal pressure (warmed, humidified CO2 gas), 8mmHg intraperitoneal pressure (warmed, humidified CO2 gas), 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20) |
Primary outcome
Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues
Time frame: at1 hour and 2 hours (day 1)
4 secondary outcomes
Quality of post-operative recovery
Time frame: at day 1
Post-operative pain
Time frame: at day 1
Per or post operative complications
Time frame: at day 1
Intraoperative core temperature
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Revaz BOTCHORISHVILI principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fisher and Paykel Humidifier (MR860AEU) in people with Laparoscopic Hysteretctomy With Promontofixation, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues (time frame: at1 hour and 2 hours (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.