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NCT07908615
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Conditions: Uterine Polyps, Uterine Fibroids, Retained Products of Conception
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 474
Sponsor: Nantes University Hospital
Location: Hopital ESTAING Clermont-Ferrand
Summary
HYPHOP is a multicenter, randomized clinical trial comparing two care pathways for women who need operative hysteroscopy to treat intrauterine lesions, such as uterine polyps, small submucosal fibroids, or retained pregnancy tissue.
Participants will be randomly assigned to one of two groups. The first group will undergo hysteroscopic morcellation/aspiration in an outpatient consultation room, without requiring an operating room. The second group will undergo hysteroscopy using a resectoscope in the operating room, usually under general or regional anesthesia.
The main objective is to determine whether outpatient hysteroscopic morcellation/aspiration provides better value for money than conventional operating-room hysteroscopy, by comparing costs and health-related quality of life over six months from inclusion.
The study will also compare symptoms, quality of life, pain, complications, the need for further treatment, patient and practitioner satisfaction, and healthcare resource use. The hypothesis is that the outpatient care pathway may reduce costs without compromising patient outcomes.
Eligibility Criteria
Inclusion Criteria:
* Female participants aged 18 years or older.
* One or more intrauterine submucosal fibroids, FIGO types 0, 1 or 2, measuring 2 cm or less, confirmed by diagnostic hysteroscopy; OR one or more intrauterine polyps confirmed by diagnostic hysteroscopy; OR retained pregnancy tissue confirmed by diagnostic hysteroscopy.
* Willingness to participate and provision of written informed consent.
* Willingness to complete follow-up for at least 12 months after the intervention and, when the intervention is delayed after inclusion, for up to 16 months from inclusion.
* Affiliation with or entitlement to a health insurance scheme.
Exclusion Criteria:
* Does not wish to undergo surgical treatment.
* Anticoagulant treatment that prevents outpatient operative hysteroscopy.
* Pregnancy or breastfeeding.
* Active pelvic or genital infection.
* Adult under a legal protection measure.
* Inability to complete the study questionnaires.
* Placement under judicial safeguard
Source: ClinicalTrials.gov (NCT07908615). StuddyBuddy aggregates publicly available trial information.