- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01488617
Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Predictors for Postoperative Outcome (MOPS)
Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.
The purpose of this study is to determine whether psychological and social factors in addition to medical (physiological) conditions may contribute significantly to the prediction of the postoperative outcome.
Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Different factors contribute to the recovery process after surgical intervention. However, little is known about the predictive value of single factors.
In addition to medical (physical) factors, depression, anxiety, somatization and avoiding coping styles are considered as relevant for the successful recovery process. These factors may be defined as "psychological distress" and could be used as predictors for perioperative complications and failed surgical treatment.
Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life.
Our sample includes adults undergoing extensive surgical interventions in trauma and orthopaedic surgery, urology, general surgery, and neurosurgery. The defined variables are measured using standardized and validated questionnaires prior to surgery and in follow-up visits.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Mainz, Tyskland, 55131
- Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Minimum Age 18 Years
- German language in speaking and writing
- Capability of giving consent
- written informed consent
Exclusion Criteria:
- Delirium, dementia or other mental disorders with significant cerebral dysfunction
- People under guardianship
- simultaneous participation in other clinical studies
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Quality of life
Tidsramme: 6 weeks and 6 months after operation
|
6 weeks and 6 months after operation
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Rita Laufenberg-Feldmann, M.D., Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
Publikationer og nyttige links
Generelle publikationer
- Laufenberg-Feldmann R, Kappis B, Camara RJA, Ferner M. Anxiety and its predictive value for pain and regular analgesic intake after lumbar disc surgery - a prospective observational longitudinal study. BMC Psychiatry. 2018 Mar 27;18(1):82. doi: 10.1186/s12888-018-1652-8.
- Laufenberg-Feldmann R, Kappis B, Mauff S, Schmidtmann I, Ferner M. Prevalence of pain 6 months after surgery: a prospective observational study. BMC Anesthesiol. 2016 Oct 10;16(1):91. doi: 10.1186/s12871-016-0261-7.
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
- MOPS 2012
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 Kirurgi
-
Assistance Publique Hopitaux De MarseilleUkendt
-
Universiti Putra MalaysiaNational Cancer Institute (NCI)AfsluttetFast Track Recovery SurgeryMalaysia
-
Richard HungerMedizinische Hochschule Brandenburg Theodor FontaneAfsluttetVolume-Outcome Relation i Pancreatic Surgery
-
Karolinska InstitutetErsta Hospital, SwedenAfsluttetLoopileostomi | Fast Track-program, (Enhanced Recovery After Surgery (ERAS))Sverige
-
University of PittsburghTrukket tilbagePostoperativ smerte | Abdominal Body Contouring SurgeryForenede Stater
-
Kahramanmaras Sutcu Imam UniversityIkke rekrutterer endnuPostoperativ smerte | Erector Spinae Plane Block i Spinal Surgery
-
Ridho Ardhi SyaifulAfsluttetKolorektale neoplasmer | Kolorektal cancer | Kolorektal kirurgi | Enhanced Recovery After Surgery (ERAS) protokol | EffektivitetIndonesien
-
Philipps University Marburg Medical CenterAfsluttetKoronar hjertesygdom | Patienternes forventninger | Koronararterie Bypass Graft Surgery (CABG)Tyskland
-
University of MichiganRekrutteringObstruktiv søvnapnø | Maxillomandibular Advancement SurgeryForenede Stater
-
Odense University HospitalRekrutteringAdipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric SurgeryDanmark