Brief Title
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
Official Title
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients
Brief Summary
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
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.
Study Type
Observational
Primary Outcome
Change in pain level for the first day
Secondary Outcome
Complications
Condition
Cholecystitis
Intervention
Spinal anesthesia
Study Arms / Comparison Groups
Spinal anesthesia group
Description: patients underwent laparoscopic cholecystectomy under spinal anesthesia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
1500
Start Date
June 2008
Completion Date
August 2016
Primary Completion Date
June 2016
Eligibility Criteria
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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Mehmet Kaplan, M.D., ,
Administrative Informations
NCT ID
NCT02956252
Organization ID
MK-011-LC
Responsible Party
Principal Investigator
Study Sponsor
Medical Park Gaziantep Hospital
Collaborators
Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
Study Sponsor
Mehmet Kaplan, M.D., Principal Investigator, Bahcesehir University, BAU
Verification Date
November 2016