Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
1 other identifier
observational
1,500
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
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
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 30, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedNovember 7, 2016
November 1, 2016
8 years
October 30, 2016
November 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Complications
within the postoperative 1 month
Mortality
within the postoperative 1 month
Gastrointestinal quality of life index
change from baseline to postoperative 1 week and 1 month
Patient satisfaction
at postoperative 1 month
Study Arms (2)
Spinal anesthesia group
patients underwent laparoscopic cholecystectomy under spinal anesthesia
General anesthesia
Patients underwent laparoscopic cholecystectomy under general anesthesia
Interventions
Spinal anesthesia was used in patients who underwent LC
General anesthesia was used in patients who underwent LC
Eligibility Criteria
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
You may qualify if:
- All patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease with no restriction for age, gender, ethnicity, disease severity, and ASA grade.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehmet Kaplan, M.D.
Bahcesehir University, BAU
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 30, 2016
First Posted
November 7, 2016
Study Start
June 1, 2008
Primary Completion
June 1, 2016
Study Completion
August 1, 2016
Last Updated
November 7, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share