Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

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Cholecystitis
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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