SurgeryMOPSNCT01488617
Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Predictors for Postoperative Outcome
An observational study of Surgery and Psychological Distress, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Psychological Distress
- How many people
- 616 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients sceduled for elective surgery.
Who may be able to join
- Minimum Age 18 Years
- German language in speaking and writing
- Capability of giving consent
- written informed consent
Who cannot join
- Delirium, dementia or other mental disorders with significant cerebral dysfunction
- People under guardianship
- simultaneous participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
Mainz, 55131
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Surgery, Psychological Distress
- Keywords
- Surgery, Psychosocial Factors, Psychological Distress, Outcome Assessment (Health Care)
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 6 weeks and 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Laufenberg-Feldmann, M.D., Johannes Gutenberg University Mainz
- Investigators
- Rita Laufenberg-Feldmann, M.D., Principal investigator, Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488617
- Sponsor's protocol ID
- MOPS 2012
- Acronym
- MOPS
- Status last verified
- Oct 2013
- First submitted
- 6 Dec 2011
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29587759Laufenberg-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.
PubMed 27724844
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Physiological and Psychological Data as Predictors for Postoperative Outcome.
- ClinicalTrials.gov ID
- NCT01488617
- Acronym / sponsor ID
- MOPS / MOPS 2012
- Conditions
- Surgery, Psychological Distress
- Keywords
- Surgery, Psychosocial Factors, Psychological Distress, Outcome Assessment (Health Care)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients sceduled for elective surgery.
Key inclusion criteria (4 listed)
- Minimum Age 18 Years
- German language in speaking and writing
- Capability of giving consent
- written informed consent
Key exclusion criteria (3 listed)
- Delirium, dementia or other mental disorders with significant cerebral dysfunction
- People under guardianship
- simultaneous participation in other clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life
Time frame: 6 weeks and 6 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Derived from this study: PubMed 29587759Laufenberg-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.
- Derived from this study: PubMed 27724844Laufenberg-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Laufenberg-Feldmann, M.D. principal investigator
Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Psychological Distress, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 weeks and 6 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01488617, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.