CholecystitisNCT02956252
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
An observational study of Cholecystitis and Gallbladder Diseases, run by Medical Park Gaziantep Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystitis, Gallbladder Diseases
- What is being tested?
- Spinal anesthesia and General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease with no restriction for age, gender, ethnicity, disease severity, and ASA grade.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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:
- Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia techniques in terms of primary outcomes.
- Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia techniques in terms of primary outcomes.
- Conditions
- Cholecystitis, Gallbladder Diseases
- Being tested
- Spinal anesthesia, General anesthesia
- Keywords
- cholecystectomy, laparoscopic, spinal anesthesia, general anesthesia, cholecystectomy
- Medical subject headings
- Cholecystitis, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Spinal anesthesia was used in patients who underwent LC
General anesthesiaProcedure or surgery
General anesthesia was used in patients who underwent LC
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia group | patients underwent laparoscopic cholecystectomy under spinal anesthesia Receives: Procedure: Spinal anesthesia | |
| General anesthesia | Patients underwent laparoscopic cholecystectomy under general anesthesia Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level for the first day
Numerical rating scale (NRS) was used
Measured: from baseline to postoperative 1, 2, 4 and 6 hours
Change in pain level for the first month
Numerical rating scale was used
Measured: From postoperative 1 week to 1 month
Secondary outcomes (4)
Complications
All types of complications were assessed
Measured: within the postoperative 1 month
Mortality
all causes of mortality were recorded
Measured: within the postoperative 1 month
Gastrointestinal quality of life index
A standard form was used under the supervision of experienced independent personal
Measured: change from baseline to postoperative 1 week and 1 month
Patient satisfaction
a verbal or visual scale was used
Measured: at postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startJun 2008
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Park Gaziantep Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
- Responsible party
- Principal investigator, Mehmet Kaplan, Medical Park Gaziantep Hospital
- Investigators
- Mehmet Kaplan, M.D., Principal investigator, Bahcesehir University, BAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956252
- Sponsor's protocol ID
- MK-011-LC
- Status last verified
- Nov 2016
- First submitted
- 30 Oct 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients
- ClinicalTrials.gov ID
- NCT02956252
- Acronym / sponsor ID
- MK-011-LC
- Conditions
- Cholecystitis, Gallbladder Diseases
- Keywords
- cholecystectomy, laparoscopic, spinal anesthesia, general anesthesia, cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Medical Park Gaziantep HospitalUniversity, hospital or other
- Collaborators
- Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
- Study start
- Jun 2008
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia techniques in terms of primary outcomes.
- Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia techniques in terms of primary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia group | – | Procedure: Spinal anesthesiapatients underwent laparoscopic cholecystectomy under spinal anesthesia |
| General anesthesia | – | Procedure: General anesthesiaPatients underwent laparoscopic cholecystectomy under general anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease with no restriction for age, gender, ethnicity, disease severity, and ASA grade.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaSpinal anesthesia was used in patients who underwent LC | Procedure or surgery | Spinal anesthesia group |
| General anesthesiaGeneral anesthesia was used in patients who underwent LC | Procedure or surgery | General anesthesia |
Primary outcome
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
Change in pain level for the first month
Time frame: From postoperative 1 week to 1 month
Numerical rating scale was used
4 secondary outcomes
Complications
Time frame: within the postoperative 1 month
Mortality
Time frame: within the postoperative 1 month
Gastrointestinal quality of life index
Time frame: change from baseline to postoperative 1 week and 1 month
Patient satisfaction
Time frame: at postoperative 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Kaplan, M.D. principal investigator
Bahcesehir University, BAU
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis and Gallbladder Diseases, run by Medical Park Gaziantep Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level for the first day (time frame: from baseline to postoperative 1, 2, 4 and 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.