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| Name | Class |
|---|---|
| Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti. | INDUSTRY |
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The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.
Laparoscopic cholecystectomy (LC) is the gold standard surgical treatment of symptomatic cholecystectomy which traditionally performed under general anesthesia. Laparoscopy has provided many advantages over open surgery for the patients; however, general anesthesia adversely affects patients' early postoperative quality of life (POQoL).
Spinal anesthesia which is a less invasive technique compared to general anesthesia has many advantages regarding the POQoL such as no need to wait for recovery from anesthesia, less nausea and vomiting, less or no pain at the end of surgery, no discomfort associated with intubation, early ambulation, fully awaken and oriented patient in the bed, and less anxious relatives.
LC has been shown to be feasible under spinal anesthesia if performed with proper technique. There are many reports demonstrated the effectiveness and safety of LC under spinal anesthesia in selected patients. However, patients with complicated gallstone disease such as acute, gangrenous or subacute cholecystitis have been considered as unfit cases for LC under spinal anesthesia because of technical difficulties. On the other hand, spinal anesthesia has also been regarded as inappropriate for patients complying with American society for anesthesiology (ASA) III and IV due to the uncontrolled anesthesia risks.
The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent LC under spinal versus general anesthesia. If proportion of general anesthesia (PGA) / proportion of spinal anesthesia (PSA) denotes the proportion rate of outcomes in the general anesthesia group (GaG) / spinal anesthesia group (SaG), then two-sided test problem is assessed as follow:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal anesthesia group | patients underwent laparoscopic cholecystectomy under spinal anesthesia |
| |
| General anesthesia | Patients underwent laparoscopic cholecystectomy under general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal anesthesia | Procedure | Spinal anesthesia was used in patients who underwent LC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain level for the first day | Numerical rating scale (NRS) was used | from baseline to postoperative 1, 2, 4 and 6 hours |
| Change in pain level for the first month | Numerical rating scale was used | From postoperative 1 week to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | All types of complications were assessed | within the postoperative 1 month |
| Mortality | all causes of mortality were recorded |
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Inclusion Criteria:
Exclusion Criteria:
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Between June 2008 and June 2016, all consecutive patients who were admitted or referred to the Medical Park Gaziantep Hospital and underwent LC for symptomatic gallbladder disease were included in the study
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Kaplan, M.D. | Bahcesehir University, BAU | Principal Investigator |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| General anesthesia | Procedure | General anesthesia was used in patients who underwent LC |
|
| within the postoperative 1 month |
| Gastrointestinal quality of life index | A standard form was used under the supervision of experienced independent personal | change from baseline to postoperative 1 week and 1 month |
| Patient satisfaction | a verbal or visual scale was used | at postoperative 1 month |