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NCT03527407: MIDAS
MIDAS: Minimal-dataset for the Assessment of Surgical Outcomes - Potential in Hip Surgery
trial in Hip Injuries in 146 participants. Completed in 6 January 2021.
6 January 2021
Quick facts
| Lead sponsor | University Hospital, Basel, Switzerland |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 146 |
| Start date | 1 July 2017 |
| Primary completion | 6 January 2021 |
| Estimated completion | 6 January 2021 |
| Sites | 1 location across Switzerland |
Conditions studied
- Hip Injuries — all drugs for Hip Injuries →
Sponsor
University Hospital, Basel, Switzerland
Who can join
18 and older, any sex, with Hip Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Swiss legislation requires health service providers to collect such information. of medical quality indicators as part of the quality and performance audit (Article 22a KVG). In addition, comparisons of clinics or specialist specialists on cost and quality of results are required (Art. 49 (8)). Currently, the quality of a medical therapy is evaluated rather negatively on the absence (or occurrence) of complications. In contrast, however, the goal of therapy must be to improve or maintain the health-related quality of life (HRQoL). Accordingly, the Swiss Society of Surgery (SGC-SSC), in collaboration with the Association for Quality Assurance in Surgery (AQC), has developed a minimum dataset designed to assess the quality of life of patients after surgical intervention. In order to enable Switzerland to be comparatively independent of the discipline, generic (in the Research Plan - MIDAS -V2, date 24.05.2017 Page 5/57 Contrary to disease-specific) survey instruments proposed that cover the general quality of life in its different facets, regardless of the function of individual organ systems. The complication documentation was not completely abandoned in this proposal, but is only a quality indicator among many due to patient-related outcome measurements. However, the development of a minimal data set with quality indicators that are applicable across all surgical sub-disciplines for evaluating the quality of treatment of acute and chronic diseases raises a number of fundamental questions that can only be answered to a limited extent without empirical studies. Five essential questions are: I. Is it sufficient to work with generic quality of life tools or is it necessary to use disease / indication specific instruments or functional tests? II. Which is the best, solid time for a follow-up? III. Is it possible and useful to make a third-party determination of the quality of life in patients with limited cognitive abilities? IV. Which preoperative risk factors should be documented so that sufficient adjustment for case mix differences in hospital comparisons can be made? V. Which perioperative and postoperative factors, in particular complications, must be raised beyond the quality of life, as they reflect an independent aspect of quality?
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03527407
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Other University Hospital, Basel, Switzerland trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03527407 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Basel, Switzerland
- Last refreshed: 18 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03527407.
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