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Measurement of residual peritoneal fluid after laparoscopic surgery
Primary endpoints
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adept | Experimental | 1000ml Adept will be left in the abdomen and measured over time |
|
| Ringer-lactate | Active Comparator | 1000 ml of Ringer lactate left in the abdomen and measured over time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon dioxide | Procedure | standard pneumoperitoneum with 100% CO2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JAsper Verguts, MD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven, campus Gasthuisberg | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D002245 | Carbon Dioxide |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
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| full conditioning |
| Procedure |
Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C |
|
| Adept | Drug | instillation of 1 liter of fluid at the end of laparoscopy |
|
| Ringer Lactate | Drug | instillation of 1 liter of fluid at the end of laparoscopy |
|
| 3 days after surgery |
| D017601 |
| Oxygen Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |