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Clinical Trial NCT07146659 for Fibroid Uterus, Polyp Uterus, Retained Products of Conception is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings 400 Observational

Recruiting
Clinical Trial NCT07146659 is an observational study for Fibroid Uterus, Polyp Uterus, Retained Products of Conception that is recruiting. It started on 1 July 2025 with plans to enroll 400 participants. Led by Centre Hospitalier Intercommunal Creteil, it is expected to complete by 31 May 2027. The latest data from ClinicalTrials.gov was last updated on 28 August 2025.
Brief 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. Secondary outcomes include postoperative pain, patient satisfaction, complications, and time to return...Show More
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 tec...

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Official Title

Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings : A Prospective Observational Study

Conditions
Fibroid UterusPolyp UterusRetained Products of Conception
Other Study IDs
  • HOPE
NCT ID Number
NCT07146659
Start Date (Actual)
2025-07-01
Last Update Posted
2025-08-28
Completion Date (Estimated)
2027-05-31
Enrollment (Estimated)
400
Study Type
Observational
Status
Recruiting
Keywords
Hysteroscopy
Operative hysteroscopy
Outpatient ambulatory
Patient satisfaction
Outpatient hysteroscopy
Complications
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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).
N/A
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
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Perioperative and postoperative pain Assessed using the Visual Analogue Scale (VAS)
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
At hospital discharge.(assessed up to 5 days)
Complications including uterine perforation, hemorrhage, and postoperative infection
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.
Up to 8 weeks postoperatively.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female

  • Women aged ≥ 18 years

    -⁃ Undergoing operative hysteroscopy for intrauterine pathology

  • Able to provid e informed non-opposition

  • French-speaking

  • Patients with contraindications to hysteroscopy
  • Pregnancy
  • Inability to complete follow-up
Centre Hospitalier Intercommunal Creteil logoCentre Hospitalier Intercommunal Creteil
Study Central Contact
Contact: Yann SALHI, MD, 0157022000, [email protected]
Contact: Elie MOSNINO, MD, [email protected]
1 Study Locations in 1 Countries
CHI Créteil - Gynécologie et obstétrique, Créteil, 94000, France
Yann SALHI, MD, Contact, [email protected]
Elie MOSNINO, MD, Contact, [email protected]
Recruiting