Trial · NCT07908615
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incremental cost-utility ratio of outpatient hysteroscopic morcellation/aspiration versus operating-room resectoscopy | Six months after inclusion | Cost-utility analysis comparing the two care pathways from a collective perspective. Costs and quality-adjusted life years (QALYs) derived from EQ-5D-5L measurements will be compared between groups. The incremental cost-utility ratio will be expressed as cost per QALY and results will also be presented as incremental net monetary benefit at different willingness-to-pay thresholds. |
| Secondary | Five-year budget impact of national adoption of outpatient hysteroscopic morcellation/aspiration | Five-year time horizon | Estimated financial impact for the French National Health Insurance system under scenarios of national adoption of outpatient hysteroscopic morcellation/aspiration instead of operating-room resectoscopy. |
| Secondary | Completeness of the operative hysteroscopy procedure | At the end of the procedure | Presence of a residual lesion identified by the surgeon at the end of the procedure. |
| Secondary | Duration of the operative hysteroscopy procedure | During the procedure | Time in minutes from insertion of the hysteroscope into the cervical canal to completion of the operative procedure, marked by the final removal of the hysteroscope. |
| Secondary | Intraoperative complications | During the operative procedure | Occurrence of complications including uterine perforation, procedure interruption for any reason, conversion to another technique, or other procedure-related complications specified in the protocol. |
| Secondary | Pain intensity and analgesic use | During and at the end of the procedure, immediately after surgery, and at Day 7 after the intervention | Pain assessed using a numerical rating scale and additional analgesic use. For the resectoscope group, immediate postoperative pain is assessed 30 minutes after awakening, with a ±30-minute window. |
| Secondary | Change in symptoms and disease-specific quality of life | At inclusion; Day 7, Month 1 and Month 12 after intervention; and Months 3 and 6 after inclusion | Symptoms assessed using the Higham score and disease-specific quality of life assessed using the UFS-QoL questionnaire, at the time points specified in the protocol. |
| Secondary | Health-related quality of life measured using EQ-5D-5L | At inclusion and at Months 3 and 6 after inclusion | Health-related quality of life measured using the EQ-5D-5L questionnaire to estimate QALYs for the cost-utility analysis. |
| Secondary | Need for further treatment or repeat intervention | At Months 1 and 12 after intervention, and Months 3 and 6 after inclusion | Proportion of participants requiring further treatment or repeat intervention at the time points specified in the protocol. |
| Secondary | Time to treatment, hospital length of stay and healthcare resource use | From inclusion through the follow-up period, as applicable | Time from inclusion to intervention, hospital length of stay, healthcare consumption and analgesic use after the procedure. |
| Secondary | Patient satisfaction with the procedure and care pathway | On the day of the procedure and at Day 7 after intervention | Satisfaction assessed on a 0-10 scale, including satisfaction with time to treatment, anesthesia, care pathway, procedure and pain management, and willingness to recommend the care pathway. |
| Secondary | Practitioner satisfaction with the procedure and care pathway | On the day of the procedure | Practitioner satisfaction assessed on a 0-10 scale, including satisfaction with time to treatment, anesthesia, care pathway, procedure and pain management. |
| Secondary | Acceptability of study participation | During recruitment | Number of women meeting eligibility criteria who decline participation and reasons for refusal |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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