Degenerative Lumbar Disease Clinical Trial
Official title:
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease
Verified date | March 2015 |
Source | General Hospital Amstetten |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Austria | General Hospital Amstetten | Amstetten |
Lead Sponsor | Collaborator |
---|---|
General Hospital Amstetten |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | at hospital discharge | No |
Secondary | Operation Duration | Duration of the operation in minutes. | after surgery | No |
Secondary | Blood Loss | Loss of blood during surgical procedure in milliliters. | after surgery | No |
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. | peri operative | No |
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. | at hospital discharge | No |
Secondary | Days of Hospitalization | Total time of hospitalization. | at hospital discharge | No |
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