Degenerative Lumbar Disease
Conditions
Keywords
complication rate in 3 cohorts (BMI < 25, > 25 and > 30)
Brief summary
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.
Interventions
None listed
Sponsors
General Hospital Amstetten
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion and
Exclusion criteria
* all patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery * patient older than 18 years * all products have been used within intended use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications in the BMI Groups During Post Operative Hospitalization. | at hospital discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation Duration | after surgery | Duration of the operation in minutes. |
| Blood Loss | after surgery | Loss of blood during surgical procedure in milliliters. |
| Number of Spine Segments | peri operative | 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. |
| Drainage | at hospital discharge | 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. |
| Days of Hospitalization | at hospital discharge | Total time of hospitalization. |
Countries
Austria
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| BMI < 25 Body Mass Index (BMI) according to WHO definition. BMI \< 25 is defined as 'normal weight'. | 20 |
| 25 <= BMI < 30 Body Mass Index (BMI) according to WHO definition. BMI \>= 25 and \< 30 is defined as 'overweight'. | 25 |
| BMI >= 30 Body Mass Index (BMI) according to WHO definition. BMI \>= 30 is defined as 'obese'. | 27 |
| Total | 72 |
Baseline characteristics
| Characteristic | 25 <= BMI < 30 | BMI >= 30 | BMI < 25 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 10 Participants | 6 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 17 Participants | 14 Participants | 40 Participants |
| Age, Continuous | 67.2 years STANDARD_DEVIATION 12.7 | 62.8 years STANDARD_DEVIATION 11.3 | 53.5 years STANDARD_DEVIATION 12.1 | 61.8 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment Austria | 25 participants | 27 participants | 20 participants | 72 participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 9 Participants | 42 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 11 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 20 | 9 / 25 | 20 / 27 |
| serious Total, serious adverse events | 0 / 20 | 0 / 25 | 0 / 27 |
Outcome results
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.
Time frame: at hospital discharge
Population: Analysis per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Complications | Postoperative Complications in the BMI Groups During Post Operative Hospitalization. | BMI < 25 | 8 Events during hospitalization |
| Complications | Postoperative Complications in the BMI Groups During Post Operative Hospitalization. | 25 >= BMI < 30 | 9 Events during hospitalization |
| Complications | Postoperative Complications in the BMI Groups During Post Operative Hospitalization. | BMI >= 30 | 20 Events during hospitalization |
Secondary
Blood Loss
Loss of blood during surgical procedure in milliliters.
Time frame: after surgery
Population: analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Complications | Blood Loss | BMI < 25 | 165.4 ml | Standard Deviation 306.5 |
| Complications | Blood Loss | 25 >= BMI < 30 | 284.4 ml | Standard Deviation 375.1 |
| Complications | Blood Loss | BMI >= 30 | 169.8 ml | Standard Deviation 175 |
Secondary
Days of Hospitalization
Total time of hospitalization.
Time frame: at hospital discharge
Population: analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Complications | Days of Hospitalization | BMI < 25 | 8.4 Days | Standard Deviation 2.17 |
| Complications | Days of Hospitalization | 25 >= BMI < 30 | 11.2 Days | Standard Deviation 8.67 |
| Complications | Days of Hospitalization | BMI >= 30 | 10.7 Days | Standard Deviation 3.51 |
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.
Time frame: at hospital discharge
Population: analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Complications | Drainage | BMI < 25 | 165.6 ml | Standard Deviation 246.8 |
| Complications | Drainage | 25 >= BMI < 30 | 150.4 ml | Standard Deviation 125.6 |
| Complications | Drainage | BMI >= 30 | 152.0 ml | Standard Deviation 141.5 |
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.
Time frame: peri operative
Population: analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Complications | Number of Spine Segments | BMI < 25 | 1.9 spine segments | Standard Deviation 0.8 |
| Complications | Number of Spine Segments | 25 >= BMI < 30 | 2.3 spine segments | Standard Deviation 1.4 |
| Complications | Number of Spine Segments | BMI >= 30 | 2.2 spine segments | Standard Deviation 1.1 |
Secondary
Operation Duration
Duration of the operation in minutes.
Time frame: after surgery
Population: analysis per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Complications | Operation Duration | BMI < 25 | 156.8 Minutes | Standard Deviation 41.6 |
| Complications | Operation Duration | 25 >= BMI < 30 | 186.2 Minutes | Standard Deviation 67.8 |
| Complications | Operation Duration | BMI >= 30 | 205.4 Minutes | Standard Deviation 76 |