- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01195584
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Amstetten, Østrig, 3300
- General Hospital Amstetten
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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'.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Complications in the BMI Groups During Post Operative Hospitalization.
Tidsramme: 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.
|
at hospital discharge
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Operation Duration
Tidsramme: after surgery
|
Duration of the operation in minutes.
|
after surgery
|
|
Blood Loss
Tidsramme: after surgery
|
Loss of blood during surgical procedure in milliliters.
|
after surgery
|
|
Number of Spine Segments
Tidsramme: 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.
|
peri operative
|
|
Drainage
Tidsramme: 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.
|
at hospital discharge
|
|
Days of Hospitalization
Tidsramme: at hospital discharge
|
Total time of hospitalization.
|
at hospital discharge
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Wolfgang Senker, MD, General Hospital Amstetten
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1-Senker
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Degenerativ lumbal sygdom
-
Taipei Veterans General Hospital, TaiwanAfsluttetDegenerativ lumbal spinal stenose | Lumbar-sakral ortose | Transforaminal Lumbal Interbody FusionTaiwan
-
Johann Wolfgang Goethe University HospitalAfsluttetFusion of Spine, Lumbar Region
-
Fudan UniversityUkendtKnoglemineraltæthed | Knogleomsætningsmarkører | Billedændringer af Lumbar FusionKina
-
Clinique Saint Jean, FranceRekrutteringFusion of Spine, Lumbar RegionFrankrig
-
National Taiwan University HospitalUkendt
-
University of Southern CaliforniaAfsluttetFusion of Spine, Lumbar RegionForenede Stater
-
Federal University of São PauloAfsluttet
-
The University of Hong KongAktiv, ikke rekrutterendeOsteoporose | Fusion of Spine, Lumbar RegionHong Kong
-
Rush University Medical CenterAfsluttetLumbal Degenerativ Disc Sygdom | Lumbal degenerativ sygdom | Degenerativ rygsøjleForenede Stater