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The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present the observation of all cumulated patients operated with MAST.
The study data will include the general health information of the subjects prior to surgery, information on the surgery such as OP time, blood loss, and the postoperative wound healing process (until discharge), which is on average the 10th postoperative day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI < 25 | Body Mass Index (WHO) established by WHO. BMI < 25 has been defined as 'normal weight'. | ||
| 25 >= BMI < 30 | Body Mass Index (WHO) established by WHO. BMI >= 25 and < 30 has been defined as 'overweight'. | ||
| BMI >= 30 | Body Mass Index (WHO) established by WHO. BMI > 30 has been defined as 'obese'. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications in the BMI Groups During Post Operative Hospitalization. | Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge. | at hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Operation Duration | Duration of the operation in minutes. | after surgery |
| Blood Loss | Loss of blood during surgical procedure in milliliters. |
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Inclusion and Exclusion Criteria:
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All patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Senker, MD | General Hospital Amstetten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Amstetten | Amstetten | 3300 | Austria |
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All patients fulfilling in- and exclusion criteria were enrolled into the retrospecitve study. All consecutive 72 patients who signed the patient informed consent were included. Patients were stratified in three groups according to their body mass index (BMI) established by WHO. Enrollment period from January 2009 - August 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | BMI < 25 | Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'. |
| FG001 | 25 <= BMI < 30 | Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'. |
| FG002 | BMI >= 30 | Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMI < 25 | Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'. |
| BG001 | 25 <= BMI < 30 | Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Complications in the BMI Groups During Post Operative Hospitalization. | Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge. | Analysis per protocol | Posted | Number | Events during hospitalization | at hospital discharge |
|
|
Events have been recorded at hospital discharge for each patient
Patients enrolled consecutively.
Only patients who signed patient informed consent have been included. The study describes the method of minimally invasive surgery and records complications related to the operation, adverse events are not linked to medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMI < 25 | Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | Non-systematic Assessment | Fever, defined as body temerature > 38°C |
The study is retrospective and all patients during the timeframe (who signed the patient informed consent) have been included into the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wolfgang Senker, MD | General Hospital Amstetten | +43 7472 6040 | 6611 | wolfgang.senker@aon.at |
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| after surgery |
| Number of Spine Segments | Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs. | peri operative |
| Drainage | Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured. | at hospital discharge |
| Days of Hospitalization | Total time of hospitalization. | at hospital discharge |
| BG002 | BMI >= 30 | Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Operation Duration | Duration of the operation in minutes. | analysis per protocol | Posted | Mean | Standard Deviation | Minutes | after surgery |
|
|
|
| Secondary | Blood Loss | Loss of blood during surgical procedure in milliliters. | analysis per protocol | Posted | Mean | Standard Deviation | ml | after surgery |
|
|
|
| Secondary | Number of Spine Segments | Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs. | analysis per protocol | Posted | Mean | Standard Deviation | spine segments | peri operative |
|
|
|
| Secondary | Drainage | Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured. | analysis per protocol | Posted | Mean | Standard Deviation | ml | at hospital discharge |
|
|
|
| Secondary | Days of Hospitalization | Total time of hospitalization. | analysis per protocol | Posted | Mean | Standard Deviation | Days | at hospital discharge |
|
|
|
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | 25 <= BMI < 30 | Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'. | 0 | 25 | 9 | 25 |
| EG002 | BMI >= 30 | Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'. | 0 | 27 | 20 | 27 |
|
| Subfebrile temperature | Infections and infestations | Non-systematic Assessment | Increase in body temperature < 38°C |
|
| Neurogenic deficit | Nervous system disorders | Non-systematic Assessment |
|
| Temporary meningism | Nervous system disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Transient Ischemic Attack | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cardiac Ischemia | Cardiac disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|
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