Clinical trial NCT02956252: Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
Official title: Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystitis
Gallbladder Diseases
Keywords: cholecystectomy, laparoscopic
spinal anesthesia
general anesthesia
cholecystectomy
Lead sponsor: Medical Park Gaziantep Hospital
Sponsor class: OTHER
Collaborators: name: Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
First posted: 2016-11-06
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Change in pain level for the first day
timeFrame: from baseline to postoperative 1, 2, 4 and 6 hours
measure: Change in pain level for the first month
timeFrame: From postoperative 1 week to 1 month
Secondary outcomes:
measure: Complications
timeFrame: within the postoperative 1 month
measure: Mortality
timeFrame: within the postoperative 1 month
measure: Gastrointestinal quality of life index
timeFrame: change from baseline to postoperative 1 week and 1 month
measure: Patient satisfaction
timeFrame: at postoperative 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Bahcesehir University, BAU
name: Mehmet Kaplan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: