Laparoscopic HysterectomyNCT01344499
Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum
A study testing Carbon dioxide, full conditioning and Adept in people with Laparoscopic Hysterectomy, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
Measurement of residual peritoneal fluid after laparoscopic surgery Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Carbon dioxide, full conditioning and Adept
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2009to Sep 2011
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent.
- No limitation in body mass index or uterine size is made.
Who cannot join
- pregnancy
- immunodeficiency
- refuse or unable to sign informed consent
- chronic disease (i.e. COPD, Crohn, cardiac…)
- known allergy for Adept©
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum
Measurement of residual peritoneal fluid after laparoscopic surgery
Read the detailed description
Primary endpoints
- to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for Adept ~30-60 ml/h)
- to evaluate the role of the mesothelial barrier in this clearance rate.
Knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (MW), our hypothesis is that clearance rate will decrease following peritoneal conditioning. Indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane
Secondary endpoints:
-To confirm the decrease in post-operative pain as measured by VAS-score and inflammation as measured by CRP and leucocytosis with the full conditioning of the pneumoperitoneum.
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Carbon dioxide, full conditioning, Adept, Ringer Lactate
- Keywords
- women, laparoscopic subtotal hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxideProcedure or surgery
standard pneumoperitoneum with 100% CO2
full conditioningProcedure or surgery
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
AdeptDrug
instillation of 1 liter of fluid at the end of laparoscopy
Ringer LactateDrug
instillation of 1 liter of fluid at the end of laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Adept | Experimental | 1000ml Adept will be left in the abdomen and measured over time Receives: Procedure: Carbon dioxide; Procedure: full conditioning; Drug: Adept |
| Ringer-lactate | Active comparator | 1000 ml of Ringer lactate left in the abdomen and measured over time Receives: Procedure: Carbon dioxide; Procedure: full conditioning; Drug: Ringer Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance rate of peritoneal fluid
We will estimate the residual volume of fluid in the abdominal cavity in a 30° anti-Trendelenburg position after 1 minute in this position. Measurements will be repeated daily until discharge.
Measured: 3 days after surgery
Secondary outcomes (1)
Pain and inflammation score
Postoperative pain will be assessed by the intake of ibuprofen or other pain killers and by Visual Analog Scale (VAS). Patients will be asked to locate their pain-symptoms (shoulder, subcostal, trocar wound and visceral pain) and score the severity. VAS will be collected 2-4 hours after surgery and every post-operative day until discharge.
Daily routine blood samples will be obtained and CRP will be measured. Routinely time of first flatus or stools will be recorded
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper Verguts, University Hospital, Gasthuisberg
- Investigators
- JAsper Verguts, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344499
- Sponsor's protocol ID
- S52808
- Status last verified
- Jun 2013
- First submitted
- 21 Apr 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum
- ClinicalTrials.gov ID
- NCT01344499
- Acronym / sponsor ID
- S52808
- Conditions
- Laparoscopic Hysterectomy
- Keywords
- women, laparoscopic subtotal hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Apr 2011 (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.
Measurement of residual peritoneal fluid after laparoscopic surgery
Detailed description
Primary endpoints
- to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for Adept ~30-60 ml/h)
- to evaluate the role of the mesothelial barrier in this clearance rate.
Knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (MW), our hypothesis is that clearance rate will decrease following peritoneal conditioning. Indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane
Secondary endpoints:
-To confirm the decrease in post-operative pain as measured by VAS-score and inflammation as measured by CRP and leucocytosis with the full conditioning of the pneumoperitoneum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adept | Experimental | Procedure: Carbon dioxide, Procedure: full conditioning, Drug: Adept1000ml Adept will be left in the abdomen and measured over time |
| Ringer-lactate | Active comparator | Procedure: Carbon dioxide, Procedure: full conditioning, Drug: Ringer Lactate1000 ml of Ringer lactate left in the abdomen and measured over time |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent.
- No limitation in body mass index or uterine size is made.
Key exclusion criteria (5 listed)
- pregnancy
- immunodeficiency
- refuse or unable to sign informed consent
- chronic disease (i.e. COPD, Crohn, cardiac…)
- known allergy for Adept©
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 |
|---|---|---|
| Carbon dioxidestandard pneumoperitoneum with 100% CO2 | Procedure or surgery | Adept, Ringer-lactate |
| full conditioningPneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C | Procedure or surgery | Adept, Ringer-lactate |
| Adeptinstillation of 1 liter of fluid at the end of laparoscopy | Drug | Adept |
| Ringer Lactateinstillation of 1 liter of fluid at the end of laparoscopy | Drug | Ringer-lactate |
Primary outcome
clearance rate of peritoneal fluid
Time frame: 3 days after surgery
We will estimate the residual volume of fluid in the abdominal cavity in a 30° anti-Trendelenburg position after 1 minute in this position. Measurements will be repeated daily until discharge.
1 secondary outcome
Pain and inflammation score
Time frame: 3 days after surgery
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 4 Jun 2013.
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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.
JAsper Verguts, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide, full conditioning and Adept in people with Laparoscopic Hysterectomy, run by University Hospital, Gasthuisberg 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 2 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 4 Jun 2013. 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?
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?
clearance rate of peritoneal fluid (time frame: 3 days after surgery). 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 4 Jun 2013.