Actively Recruiting
Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings: A Prospective Observational Study
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-08-28
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating operative hysteroscopy procedures used to treat intrauterine problems such as endometrial polyps, fibroids, and retained products of conception. The study compares the success rates of these procedures performed in the operating room under general or regional anesthesia with those done in outpatient settings without such anesthesia. This prospective observational study aims to understand differences in outcomes like pain, patient satisfaction, complications, and recovery time. Participants will undergo operative hysteroscopy either in a surgical setting with anesthesia or in an outpatient consultation room using local anesthesia if needed. The study will include about 400 patients over two years, with data collected from medical records and patient questionnaires. No additional interventions or follow-up beyond standard care will be required. During the study, researchers will assess the success of each procedure based on surgeon reports at the end of surgery. They will also measure pain levels during and after the procedure, patient satisfaction shortly after discharge, and track any complications up to eight weeks later. Additionally, the time taken to return to work will be recorded, providing a comprehensive view of recovery and outcomes for both settings.
CONDITIONS
Brief Title
Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 2518 years or older
- Undergoing operative hysteroscopy for intrauterine pathology
- Able to provide informed non-opposition
- French-speaking
You will not qualify if you...
- Patients with contraindications to hysteroscopy
- Pregnancy
- Inability to complete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day procedure
Participants undergo operative hysteroscopy either in the operating room under anesthesia or in an outpatient setting without general or regional anesthesia.
1 procedure visit (in-person)
Duration - Up to 5 days
Participants are assessed for perioperative and postoperative pain, complications, and patient satisfaction up to 5 days after the procedure.
1 to 2 follow-up visits depending on clinical need
Duration - Up to 8 weeks
Participants are monitored for complications such as uterine perforation, hemorrhage, infection, and time to return to work for up to 8 weeks postoperatively.
1 follow-up visit (in-person) if necessary
Trial Site Locations
Total: 1 location
1
CHI Créteil - Gynécologie et obstétrique
Créteil, France, 94000
Actively Recruiting
Research Team
Y
Yann SALHI, MD
E
Elie MOSNINO, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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