Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia techniques in terms of primary outcomes. Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia techniques in terms of primary outcomes.

Official Title
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Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients

Conditions
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Cholecystitis, Gallbladder Diseases

Intervention / Treatment
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* Procedure: Spinal anesthesia
* Procedure: General anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease with no restriction for age, gender, ethnicity, disease severity, and ASA grade. Exclusion Criteria: Patients were excluded if they underwent concurrent surgeries, had malignancy suspicion, received or converted to open surgery, and patients who were under spinal anesthesia converted to general anesthesia.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spinal anesthesia group<br>patients underwent laparoscopic cholecystectomy under spinal anesthesia | Procedure: Spinal anesthesia<br>* Spinal anesthesia was used in patients who underwent LC<br>|
| General anesthesia<br>Patients underwent laparoscopic cholecystectomy under general anesthesia | Procedure: General anesthesia<br>* General anesthesia was used in patients who underwent LC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | All types of complications were assessed | within the postoperative 1 month | 
| Mortality | all causes of mortality were recorded | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy, laparoscopic, spinal anesthesia, general anesthesia, cholecystectomy