An interventional study of Operating-room hysteroscopy with resectoscope and Outpatient hysteroscopic morcellation/aspiration in Uterine Polyps, Uterine Fibroids and Retained Products of Conception, sponsored by Nantes University Hospital. Not yet recruiting at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Health services research
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.
HYPHOP is a prospective, multicenter, open-label, randomized controlled trial with two parallel groups. The study evaluates two care pathways for women requiring operative hysteroscopy for intrauterine pathologies.
After diagnostic hysteroscopy confirms the indication for operative treatment, eligible participants who provide written informed consent will complete baseline questionnaires and be randomly assigned to one of two groups. Randomization will be stratified by study center and indication (fibroid, polyp, or retained pregnancy tissue).
In the first group, operative hysteroscopy will be performed using a morcellation/aspiration system in a dedicated outpatient consultation room. Analgesia options may include non-steroidal anti-inflammatory medication, local anesthesia, virtual reality, and/or an equimolar mixture of oxygen and nitrous oxide, according to the participant's preference and clinical circumstances.
In the second group, operative hysteroscopy will be performed using a resectoscope in the operating room, with general or regional anesthesia according to the usual care pathway and the clinical decision.
The intervention may take place on the day of inclusion or subsequently, depending on the assigned care pathway and operating-room or outpatient scheduling, with a maximum delay of four months after inclusion.
The primary objective is to conduct a cost-utility analysis comparing the two care pathways over a six-month horizon from inclusion, using a collective perspective. Health-related quality of life will be measured using the EQ-5D-5L questionnaire at inclusion, three months, and six months. Quality-adjusted life years (QALYs) will be estimated from these measurements, and costs will be compared between groups. The incremental cost-utility ratio will be expressed as cost per QALY, with results also presented as incremental net monetary benefit for different willingness-to-pay values.
The six-month horizon begins at inclusion rather than at the intervention because the time to treatment may differ between the two groups. Consequently, assessments at three and six months from inclusion may occur at different intervals after the intervention in the two groups.
Secondary assessments include treatment completeness, procedure duration, intraoperative complications, pain, analgesic use, symptoms measured using the Higham score and UFS-QoL questionnaire, health-related quality of life, the need for further treatment, healthcare resource use, length of hospital stay, and patient and practitioner satisfaction. A five-year budget impact analysis will also assess scenarios for the national adoption of outpatient hysteroscopic morcellation/aspiration.
The planned sample size is 474 participants.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 474 is above the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo operative hysteroscopy using a resectoscope in the operating room, with general or regional anesthesia according to the usual care pathway and clinical decision.
Procedure: Operating-room hysteroscopy with resectoscope
Participants undergo operative hysteroscopy using a morcellation/aspiration system in a dedicated outpatient consultation room, without an operating-room pathway. Analgesia options may include non-steroidal anti-inflammatory medication, local anesthesia, virtual reality and/or an equimolar mixture of oxygen and nitrous oxide, according to participant preference and clinical circumstances.
Procedure: Outpatient hysteroscopic morcellation/aspiration
A resectoscope is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the examination of the uterus and the treatment of gynecological conditions through the natural passages (vagina, cervix). It provides direct access to the interior of the uterine cavity without the need for an abdominal incision. The procedure is performed in the operating room under general or regional anesthesia. The resectoscope is used for myomectomy, polypectomy, resection of retained trophoblasts or placental remnants, or division of a septum The procedure is performed as follows: 1. Positioning of the patient and anesthesia 2. Insertion of the resectoscope and exploration 3. Surgical phase 4. Removal of the resectoscope and monitoring The procedure is contraindicated in cases of active genital infection
The therapeutic hysteroscope with fragmentation and aspiration is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the rapid and precise removal of abnormal tissue without the need for incisions. The procedure is performed in a dedicated examination room (clean room). It can be used outside the operating room with or without local anesthesia. Morcellation/aspiration hysteroscopy is indicated for myomectomy, polypectomy, and resection of retained trophoblasts or placental remnants. The procedure is performed as follows: 1. Positioning of the patient, with or without multimodal anesthesia 2. Insertion of the therapeutic fragmentation-aspiration hysteroscope and exploration 3. Surgical phase 4. Removal of the therapeutic fragmentation-aspiration hysteroscope and monitoring The procedure is contraindicated in cases of active genital infection
Incremental cost-utility ratio of outpatient hysteroscopic morcellation/aspiration versus operating-room resectoscopy
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.
Time frame: Six months after inclusion
Five-year budget impact of national adoption of outpatient hysteroscopic morcellation/aspiration
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.
Time frame: Five-year time horizon
Completeness of the operative hysteroscopy procedure
Presence of a residual lesion identified by the surgeon at the end of the procedure.
Time frame: At the end of the procedure
Duration of the operative hysteroscopy 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.
Time frame: During the procedure
Intraoperative complications
Occurrence of complications including uterine perforation, procedure interruption for any reason, conversion to another technique, or other procedure-related complications specified in the protocol.
Time frame: During the operative procedure
Pain intensity and analgesic use
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.
Time frame: During and at the end of the procedure, immediately after surgery, and at Day 7 after the intervention
Change in symptoms and disease-specific quality of life
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.
Time frame: At inclusion; Day 7, Month 1 and Month 12 after intervention; and Months 3 and 6 after inclusion
Health-related quality of life measured using EQ-5D-5L
Health-related quality of life measured using the EQ-5D-5L questionnaire to estimate QALYs for the cost-utility analysis.
Time frame: At inclusion and at Months 3 and 6 after inclusion
Need for further treatment or repeat intervention
Proportion of participants requiring further treatment or repeat intervention at the time points specified in the protocol.
Time frame: At Months 1 and 12 after intervention, and Months 3 and 6 after inclusion
Time to treatment, hospital length of stay and healthcare resource use
Time from inclusion to intervention, hospital length of stay, healthcare consumption and analgesic use after the procedure.
Time frame: From inclusion through the follow-up period, as applicable
Patient satisfaction with the procedure and care pathway
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.
Time frame: On the day of the procedure and at Day 7 after intervention
Practitioner satisfaction with the procedure and care pathway
Practitioner satisfaction assessed on a 0-10 scale, including satisfaction with time to treatment, anesthesia, care pathway, procedure and pain management.
Time frame: On the day of the procedure
Acceptability of study participation
Number of women meeting eligibility criteria who decline participation and reasons for refusal
Time frame: During recruitment
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2029, 31 months later.
Of 52 non-industry interventional studies with no phase under Leiomyoma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 31 months is close to that.
Counting every sponsor, half of 57 studies reached it within 31 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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