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Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02956252
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
Information provided by (Responsible Party):
Mehmet Kaplan, Medical Park Gaziantep Hospital

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.

Condition or disease Intervention/treatment
Cholecystitis Gallbladder Diseases Procedure: Spinal anesthesia Procedure: 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.

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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients
Study Start Date : June 2008
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Spinal anesthesia group
patients underwent laparoscopic cholecystectomy under spinal anesthesia
Procedure: Spinal anesthesia
Spinal anesthesia was used in patients who underwent LC

General anesthesia
Patients underwent laparoscopic cholecystectomy under general anesthesia
Procedure: General anesthesia
General anesthesia was used in patients who underwent LC




Primary Outcome Measures :
  1. Change in pain level for the first day [ Time Frame: from baseline to postoperative 1, 2, 4 and 6 hours ]
    Numerical rating scale (NRS) was used

  2. Change in pain level for the first month [ Time Frame: From postoperative 1 week to 1 month ]
    Numerical rating scale was used


Secondary Outcome Measures :
  1. Complications [ Time Frame: within the postoperative 1 month ]
    All types of complications were assessed

  2. Mortality [ Time Frame: within the postoperative 1 month ]
    all causes of mortality were recorded

  3. Gastrointestinal quality of life index [ Time Frame: change from baseline to postoperative 1 week and 1 month ]
    A standard form was used under the supervision of experienced independent personal

  4. Patient satisfaction [ Time Frame: at postoperative 1 month ]
    a verbal or visual scale was used



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956252


Sponsors and Collaborators
Medical Park Gaziantep Hospital
Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
Investigators
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Principal Investigator: Mehmet Kaplan, M.D. Bahcesehir University, BAU

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Responsible Party: Mehmet Kaplan, Principal Investigator, Medical Park Gaziantep Hospital
ClinicalTrials.gov Identifier: NCT02956252     History of Changes
Other Study ID Numbers: MK-011-LC
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mehmet Kaplan, Medical Park Gaziantep Hospital:
cholecystectomy, laparoscopic
spinal anesthesia
general anesthesia
cholecystectomy
Additional relevant MeSH terms:
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Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs