LaparotomyNCT01098175
Peritoneal Cavity Conditioning During Open Surgery.
An observational study of Laparotomy and Thoracotomy, run by KU Leuven at 1 site in Belgium.
Trial summary
Given the observations in animal models and the available data in the human our hypothesis is that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100% humidification at 32°C,) during open surgery, will result in an important decrease in postoperative peritoneal inflammation… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparotomy, Thoracotomy
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to Dec 2011
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Standard open surgery such as hysterectomy, cancer surgery, bowel resections, cardiac surgery
Who may be able to join
- patients will be stratified and randomised according to the type of surgery
- total laparoscopic hysterectomy,
- promontofixation
- cholecystectomy
Who cannot join
- Any pre-existing condition increasing the risk of surgery such as age, pre-existing conditions as clotting disorders, heart or lung impairment etc.
- Not signed informed consent
- known allergic reaction to Sprayshield, Intercoat of hyalobarrier gel ® or - any bowel lesion requiring a single or double layer suture. (given that for none of the any anti-adhesion barriers safety has been proven following bowel lesions and suture)
- Any condition that might interfere with inflammatory parameters or pre-existing such as ,pregnancy, immunodeficiency, chronic inflammatory disease as Crohn's disease, chronic pain conditions as (peripheral neuropathy, pathology of the vertebral column and osteo-articular disease, any condition causing acute pain e.g. trauma.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Gasthuisberg
Leuven, 3000
Philippe R Koninckx, MD
Jasper Verguts, MD
About this study
Official title: Peritoneal Cavity Conditioning During Open Surgery Decreases Postoperative Pain and Inflammation and Decreases Time to Restore Transit
Given the observations in animal models and the available data in the human our hypothesis is that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100% humidification at 32°C,) during open surgery, will result in an important decrease in postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit faster.
Read the detailed description
Aim of the Trial :
RCT demonstrating that peritoneal cavity conditioning during open surgery will result in a less postoperative inflammation, less postoperative pain, and shorter time to flatus and transit.
- Conditions
- Laparotomy, Thoracotomy
- Keywords
- laparotomy, thoracotomy, peritoneal conditioning, humidification, temperature control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | open surgery with exposure of the surgical wound to the air. | |
| Full peritoneal conditioning | Full peritoneum cavity conditioning will be performed as follows. A continuous flow of less than 0.5 l/min of gas will be instilled in the lowest part of the operating wound. As gas premixed bottles with CO2+ 4% of oxygen and 10% of N2O will be used. This gas will be humidified and at 31-32 °C to be achieved by a commercial humidifier (Fisher and Paykel) programmed in order to maintain 100% relative humidity at 31-32°C upon entrance of the peritoneal cavity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint : decreased pain on day 1 and 2 after surgery
Postoperative pain : will be assessed by visual analog scales (cfr Trial by Verguts \& Koninckx, addendum I) assessed pain on day 1, 2 and 3 after surgery. Pain medication will be free, but preferentially ibuprofen will be used in order to permit easier comparison of pain killer intake.
Measured: 0 to 7 days
Secondary outcomes (3)
decrease in CRP and inflammatory parameters on day 1 and 2 or longer
Postoperative inflammatory reaction : daily assessment of inflammatory parameters as CRP, leucocytosis , and temperature for 4 to 7 days are done routinely today.
In some subsets of patients other more specific inflammatory parameters as Ca125, IL-6 can be investigated
Measured: day 1-4
lower peritoneal fluid volume on day 2
Estimation of peritoneal fluid volume by ultrasound on the second day after surgery will be performed in some subsets of patients. We indeed recently validated a non-invasive and reliable assessment of peritoneal fluid volume by ultrasound. (Verguts et all, 2009) We expect that the postoperative peritoneal fluid volume will increase with the degree of peritoneal inflammation.
Measured: day 2 after surgery
Shorter time to resumption of transit: time to first flatus and time to first stool
Time to first flatus and time to first stool will be recorded
Measured: day1 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- philippe R Koninckx, MD, Principal investigator, UZ Gasthuisberg, KULeuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098175
- Sponsor's protocol ID
- S52233
- Status last verified
- Mar 2010
- First submitted
- 1 Apr 2010
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Cavity Conditioning During Open Surgery Decreases Postoperative Pain and Inflammation and Decreases Time to Restore Transit
- ClinicalTrials.gov ID
- NCT01098175
- Acronym / sponsor ID
- S52233
- Conditions
- Laparotomy, Thoracotomy
- Keywords
- laparotomy, thoracotomy, peritoneal conditioning, humidification, temperature control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Apr 2010 (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.
Given the observations in animal models and the available data in the human our hypothesis is that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100% humidification at 32°C,) during open surgery, will result in an important decrease in postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit faster.
Detailed description
Aim of the Trial :
RCT demonstrating that peritoneal cavity conditioning during open surgery will result in a less postoperative inflammation, less postoperative pain, and shorter time to flatus and transit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –open surgery with exposure of the surgical wound to the air. |
| Full peritoneal conditioning | – | –Full peritoneum cavity conditioning will be performed as follows. A continuous flow of less than 0.5 l/min of gas will be instilled in the lowest part of the operating wound. As gas premixed bottles with CO2+ 4% of oxygen and 10% of N2O will be used. This gas will be humidified and at 31-32 °C to be achieved by a commercial humidifier (Fisher and Paykel) programmed in order to maintain 100% relative humidity at 31-32°C upon entrance of the peritoneal cavity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Standard open surgery such as hysterectomy, cancer surgery, bowel resections, cardiac surgery
Key inclusion criteria (4 listed)
- patients will be stratified and randomised according to the type of surgery
- total laparoscopic hysterectomy,
- promontofixation
- cholecystectomy
Key exclusion criteria (4 listed)
- Any pre-existing condition increasing the risk of surgery such as age, pre-existing conditions as clotting disorders, heart or lung impairment etc.
- Not signed informed consent
- known allergic reaction to Sprayshield, Intercoat of hyalobarrier gel ® or - any bowel lesion requiring a single or double layer suture. (given that for none of the any anti-adhesion barriers safety has been proven following bowel lesions and suture)
- Any condition that might interfere with inflammatory parameters or pre-existing such as ,pregnancy, immunodeficiency, chronic inflammatory disease as Crohn's disease, chronic pain conditions as (peripheral neuropathy, pathology of the vertebral column and osteo-articular disease, any condition causing acute pain e.g. trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint : decreased pain on day 1 and 2 after surgery
Time frame: 0 to 7 days
Postoperative pain : will be assessed by visual analog scales (cfr Trial by Verguts \& Koninckx, addendum I) assessed pain on day 1, 2 and 3 after surgery. Pain medication will be free, but preferentially ibuprofen will be used in order to permit easier comparison of pain killer intake.
3 secondary outcomes
decrease in CRP and inflammatory parameters on day 1 and 2 or longer
Time frame: day 1-4
lower peritoneal fluid volume on day 2
Time frame: day 2 after surgery
Shorter time to resumption of transit: time to first flatus and time to first stool
Time frame: day1 to 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
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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.
philippe R Koninckx, MD principal investigator
UZ Gasthuisberg, KULeuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparotomy and Thoracotomy, run by KU Leuven at 1 site in Belgium.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Apr 2010. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe R Koninckx, MD (+32 16 344202, pkoninckx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint : decreased pain on day 1 and 2 after surgery (time frame: 0 to 7 days). 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 2 Apr 2010; AzTrials last refreshed its copy on 27 Oct 2026.