Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
SALC
A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients
1 other identifier
interventional
300
1 country
1
Brief Summary
The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJanuary 14, 2010
June 1, 2008
6 years
June 26, 2007
January 13, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative pain
24hrs
Secondary Outcomes (3)
complications
30 days
hospital stay
time from intervention to discharge
patient satisfaction
within 2 weeks from intervention
Study Arms (2)
1
ACTIVE COMPARATORLaparoscopic cholecystectomy under spinal anesthesia
2
ACTIVE COMPARATORLaparoscopic cholecystectomy under general anesthesia
Interventions
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
Eligibility Criteria
You may qualify if:
- elective laparoscopic cholecystectomy
- ASA I, II
- BMI\< 30
- normal coagulation profile
You may not qualify if:
- acute cholecystitis / cholangitis / pancreatitis
- previous open surgery in the upper abdomen
- contraindication for pneumoperitoneum
- contraindication for spinal anesthesia (ie spinal deformity)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Thessalylead
- Larissa University Hospitalcollaborator
Study Sites (1)
University Hospital of Larissa
Larissa, Thessaly, 411 10, Greece
Related Publications (2)
Tzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Laparoscopic cholecystectomy under spinal anesthesia: a pilot study. Surg Endosc. 2006 Apr;20(4):580-2. doi: 10.1007/s00464-005-0405-1. Epub 2006 Jan 25.
PMID: 16437265BACKGROUNDTzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Spinal vs general anesthesia for laparoscopic cholecystectomy: interim analysis of a controlled randomized trial. Arch Surg. 2008 May;143(5):497-501. doi: 10.1001/archsurg.143.5.497.
PMID: 18490561RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Constantine Hatzitheofilou, MD
University of Thessaly, School of Medicine
- STUDY DIRECTOR
George Tzovaras, MD
University of Thessaly, School of Medicine
- PRINCIPAL INVESTIGATOR
Frank Fafoulakis, MD
University Hospital of Larissa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
September 1, 2004
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
January 14, 2010
Record last verified: 2008-06