Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients

The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Gallbladder Diseases
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 1500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	All types of complications were assessed	within the postoperative 1 month
Mortality	all causes of mortality were recorded	within the postoperative 1 month
Gastrointestinal quality of life index	A standard form was used under the supervision of experienced independent personal	change from baseline to postoperative 1 week and 1 month
Patient satisfaction	a verbal or visual scale was used	at postoperative 1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 30, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: general anesthesia; spinal anesthesia; cholecystectomy; cholecystectomy, laparoscopic
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Cholecystitis; Gallbladder Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MK-011-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No