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| Name | Class |
|---|---|
| Hospital General Universitario Gregorio Marañon | OTHER |
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Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.
Patients scheduled for open colorectal cancer surgery were randomly allocated to receive general anesthesia (CON group, n=22) or general anesthesia with thoracic epidural anesthesia (EPI group, n=21). Patients undergoing laparoscopic surgery (LAP group, n=20) composed the third arm of the study. Measurement of perioperative changes in several hormones and cytokines were blinded to group assignment.
Primary outcome: Compare simultaneously two types of surgical and anesthesia techniques for colorectal cancer surgery and measure to what extent the stress response is lessened.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Control group: open surgery under general anesthesia |
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| Epidural group | Active Comparator | Epidural group: Open surgery under thoracic epidural anesthesia |
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| Laparoscopic group | Active Comparator | Laparoscopic group: Laparoscopic surgery under general anesthesia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic technique and thoracic epidural anesthesia | Procedure | We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of several cytokines after colorectal cancer surgery | We have measured and compared perioperative plasma levels of interleukin-1, interleukin-2, interleukin-6,monocyte chemotactic protein-1, interleukin-8, nitric oxide, C-reactive protein and procalcitonin in our three-group sample. | within the first two days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse clinical outcomes between groups | We have analyzed if there is any significant difference on respiratory, cardiac, renal or infectious postoperative complications between groups | within 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Duque, MD | Gregorio Marañon Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gregorio Marañon Hospital | Madrid | Madrid | 28007 | Spain |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |