Fibroid UterusNCT07146659
Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings
An observational study of Fibroid Uterus and Polyp Uterus, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
This is an observational prospective monocentric study which aims to compare operative hysteroscopies performed in the operating room under general or loco-regional anesthesia and those performed outside the operating room (outpatient operative hysteroscopy). The primary outcome is the success rate of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroid Uterus, Polyp Uterus, Retained Products of Conception
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women requiring operative hysteroscopy for intrauterine pathology
Who may be able to join
- Women aged ≥ 18 years
- -⁃ Undergoing operative hysteroscopy for intrauterine pathology
- Able to provid e informed non-opposition
- French-speaking
Who cannot join
- Patients with contraindications to hysteroscopy
- Pregnancy
- Inability to complete follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elie MOSNINO, MD contact
France1 site, 1 recruiting
- Recruiting
CHI Créteil - Gynécologie et obstétrique
Créteil, 94000
Yann SALHI, MD, yann.salhi@chicreteil.fr
Elie MOSNINO, MD, elie.mosnino@gmail.com
About this study
Official title: Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings : A Prospective Observational Study
This is an observational prospective monocentric study which aims to compare operative hysteroscopies performed in the operating room under general or loco-regional anesthesia and those performed outside the operating room (outpatient operative hysteroscopy). The primary outcome is the success rate of the procedure. Secondary outcomes include postoperative pain, patient satisfaction, complications, and time to return to work.
Read the detailed description
Operative hysteroscopy is a key technique for the treatment of intrauterine pathologies such as endometrial polyps, submucosal fibroids, retained products of conception. Traditionally, operative hysteroscopies are performed in the operating room under general or regional anesthesia, requiring either ambulatory or inpatient hospitalization.
In recent years, advances in hysteroscopic instrumentation and procedural techniques have made it possible to perform selected operative hysteroscopies in outpatient settings (consultation office) without general or regional anesthesia. Several studies have demonstrated the feasibility, safety, and effectiveness of outpatient operative hysteroscopy, with similar success rates and complication profiles compared to procedures performed in the operating room, although some studies reported higher levels of pain during outpatient procedures (1-3) . Furthermore, cost-effectiveness studies support outpatient procedures by highlighting reduced hospital resource utilization and shorter recovery times for patients (4-6).
The HOPE study aims to evaluate this practice locally at the Centre Hospitalier Intercommunal de Créteil. This prospective monocentric observational study will include approximately 400 patients over a two-year period (July 2025 - May 2027). The primary objective is to compare the success rates of operative hysteroscopies performed in the operating room versus those performed in an outpatient setting. Secondary objectives include assessment of perioperative and postoperative pain, patient satisfaction, complication rates, and the time to return to work.
Data will be collected from medical records and patient-reported outcomes using a satisfaction questionnaire. Inclusion of patients will follow the usual care pathway, without additional interventions or follow-up beyond standard clinical practice.
- Keywords
- Hysteroscopy, Operative hysteroscopy, Outpatient ambulatory, Patient satisfaction, Outpatient hysteroscopy, Complications
- Medical subject headings
- Leiomyoma, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Operative hysteroscopy in the operating room | Operative hysteroscopy in the operating room: Procedures performed under general or regional anesthesia in a surgical setting (either ambulatory or conventional hospitalization). | |
| Operative hysteroscopy in the outpatient setting | Operative hysteroscopy in the outpatient setting: Procedures performed in a consultation room without general or regional anesthesia, using local anesthesia if needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
This will be assessed as an ordinal qualitative variable, with procedures classified into three categories:number of complete success, number of partial success, or number of failure.
Measured: The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)
Secondary outcomes (4)
Perioperative and postoperative pain Assessed using the Visual Analogue Scale (VAS)
Measured: During the procedure (if the patient is awake), immediately after the procedure, and at hospital discharge (baseline)
Patient satisfaction Assessed using a locally developed patient satisfaction questionnaire
Measured: At hospital discharge.(assessed up to 5 days)
Complications including uterine perforation, hemorrhage, and postoperative infection
Measured: Recorded during the procedure and immediately afterward (documented in the operative report and medical records), and up to 8 weeks postoperatively during the follow-up consultation if necessary.
4. Time to return to work Measured as the number of days of sick leave prescribed and actually taken.
Measured: Up to 8 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Jul 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146659
- Sponsor's protocol ID
- HOPE
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07146659
- Acronym / sponsor ID
- HOPE
- Keywords
- Hysteroscopy, Operative hysteroscopy, Outpatient ambulatory, Patient satisfaction, Outpatient hysteroscopy, Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- 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.
This is an observational prospective monocentric study which aims to compare operative hysteroscopies performed in the operating room under general or loco-regional anesthesia and those performed outside the operating room (outpatient operative hysteroscopy). The primary outcome is the success rate of the procedure. Secondary outcomes include postoperative pain, patient satisfaction, complications, and time to return to work.
Detailed description
Operative hysteroscopy is a key technique for the treatment of intrauterine pathologies such as endometrial polyps, submucosal fibroids, retained products of conception. Traditionally, operative hysteroscopies are performed in the operating room under general or regional anesthesia, requiring either ambulatory or inpatient hospitalization.
In recent years, advances in hysteroscopic instrumentation and procedural techniques have made it possible to perform selected operative hysteroscopies in outpatient settings (consultation office) without general or regional anesthesia. Several studies have demonstrated the feasibility, safety, and effectiveness of outpatient operative hysteroscopy, with similar success rates and complication profiles compared to procedures performed in the operating room, although some studies reported higher levels of pain during outpatient procedures (1-3) . Furthermore, cost-effectiveness studies support outpatient procedures by highlighting reduced hospital resource utilization and shorter recovery times for patients (4-6).
The HOPE study aims to evaluate this practice locally at the Centre Hospitalier Intercommunal de Créteil. This prospective monocentric observational study will include approximately 400 patients over a two-year period (July 2025 - May 2027). The primary objective is to compare the success rates of operative hysteroscopies performed in the operating room versus those performed in an outpatient setting. Secondary objectives include assessment of perioperative and postoperative pain, patient satisfaction, complication rates, and the time to return to work.
Data will be collected from medical records and patient-reported outcomes using a satisfaction questionnaire. Inclusion of patients will follow the usual care pathway, without additional interventions or follow-up beyond standard clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative hysteroscopy in the operating room | – | –Operative hysteroscopy in the operating room: Procedures performed under general or regional anesthesia in a surgical setting (either ambulatory or conventional hospitalization). |
| Operative hysteroscopy in the outpatient setting | – | –Operative hysteroscopy in the outpatient setting: Procedures performed in a consultation room without general or regional anesthesia, using local anesthesia if needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women requiring operative hysteroscopy for intrauterine pathology
Key inclusion criteria (4 listed)
- Women aged ≥ 18 years
- -⁃ Undergoing operative hysteroscopy for intrauterine pathology
- Able to provid e informed non-opposition
- French-speaking
Key exclusion criteria (3 listed)
- Patients with contraindications to hysteroscopy
- Pregnancy
- Inability to complete follow-up
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
This will be assessed as an ordinal qualitative variable, with procedures classified into three categories:number of complete success, number of partial success, or number of failure.
Time frame: The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)
4 secondary outcomes
Perioperative and postoperative pain Assessed using the Visual Analogue Scale (VAS)
Time frame: During the procedure (if the patient is awake), immediately after the procedure, and at hospital discharge (baseline)
Patient satisfaction Assessed using a locally developed patient satisfaction questionnaire
Time frame: At hospital discharge.(assessed up to 5 days)
Complications including uterine perforation, hemorrhage, and postoperative infection
Time frame: Recorded during the procedure and immediately afterward (documented in the operative report and medical records), and up to 8 weeks postoperatively during the follow-up consultation if necessary.
4. Time to return to work Measured as the number of days of sick leave prescribed and actually taken.
Time frame: Up to 8 weeks postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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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.
Elie MOSNINO, MD contact
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 Fibroid Uterus and Polyp Uterus, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yann SALHI, MD (0157022000 ext. 8456, yann.salhi@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This will be assessed as an ordinal qualitative variable, with procedures classified into three categories:number of complete success, number of partial success, or number of failure. (time frame: The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.