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CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures. Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion through prevention of mesothelial hypoxia. We want to prove this concept in human and expand it to the use of full conditioning.
In order to confirm the animal data in the human, a first RCT was performed in which 20 women undergoing a laparoscopy for at least 60 minutes were randomised to a pneumoperitoneum with either 100% carbon dioxide or 96% carbon dioxide plus 4% of oxygen. Insufflation pressure and Trendelenburg were standardised at 15 mm Hg and 30° respectively. In a second trial women were randomized to either 100% carbon dioxide or 86% carbon dioxide plus 4% of oxygen + 10% nitrous oxide + humidification and set temperature of 32°C of the peritoneal cavity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4% oxygen | Experimental | addition of 4% oxygen to the CO2 pneumoperitoneum |
|
| full conditioning | Experimental | full conditioning of the peritoneal cavity by the laparoscopic gas: 4% oxygen, 10% nitrous oxide, humidification and set temperature of 32°C |
|
| CO2 pneumoperitoneum | Active Comparator | standard laparoscopy with CO2 pneumoperitoneum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alteration of the insufflation gas | Procedure | addition of 4% oxygen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CO2 absorption | Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia) | measurements for 60 to 240 minutes on average during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| hemodynamic alterations | control of other hemodynamic alterions during laparoscopic surgery. | measurements for 60 to 240 minutes on average during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven, campus Gasthuisberg | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| D004715 | Endometriosis |
| D000267 | Tissue Adhesions |
| D009214 | Myoma |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| full conditioning |
| Procedure |
addition of 4% oxygen + 10% nitrous oxide to the peritoneum
|
|
| standard pneumoperitoneum | Procedure | no intervention besides the use of CO2 |
|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |