Laparoscopic Hysterectomy
Conditions
Keywords
women, laparoscopic subtotal hysterectomy
Brief summary
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.
Interventions
PROCEDURECarbon dioxide
standard pneumoperitoneum with 100% CO2
PROCEDUREfull conditioning
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
DRUGAdept
instillation of 1 liter of fluid at the end of laparoscopy
DRUGRinger Lactate
instillation of 1 liter of fluid at the end of laparoscopy
Sponsors
University Hospital, Gasthuisberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* pregnancy * immunodeficiency * refuse or unable to sign informed consent * chronic disease (i.e. COPD, Crohn, cardiac…) * known allergy for Adept©
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clearance rate of peritoneal fluid | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and inflammation score | 3 days after surgery | 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 |
Countries
Belgium
Outcome results
None listed