Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956252
• Other study ID #: MK-011-LC
• Status: Completed
• Phase: N/A
• First received: October 30, 2016
• Last updated: November 4, 2016
• Start date: June 2008
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Medical Park Gaziantep Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cholecystitis
• Gallbladder Diseases

Intervention

Procedure:
• Spinal anesthesia
Spinal anesthesia was used in patients who underwent LC
• General anesthesia
General anesthesia was used in patients who underwent LC

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical Park Gaziantep Hospital	Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain level for the first day	Numerical rating scale (NRS) was used	from baseline to postoperative 1, 2, 4 and 6 hours	No
Primary	Change in pain level for the first month	Numerical rating scale was used	From postoperative 1 week to 1 month	No
Secondary	Complications	All types of complications were assessed	within the postoperative 1 month	Yes
Secondary	Mortality	all causes of mortality were recorded	within the postoperative 1 month	Yes
Secondary	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	No
Secondary	Patient satisfaction	a verbal or visual scale was used	at postoperative 1 month	No