Cholecystitis Clinical Trial
Official title:
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients
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:
1. Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia
techniques in terms of primary outcomes.
2. Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia
techniques in terms of primary outcomes.
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Observational Model: Cohort, Time Perspective: Retrospective
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