Actively Recruiting

Age: 18Years +
FEMALE
ID07146659

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Operative Hysteroscopy Procedure

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)

Post-procedure Observation and Assessment

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

Follow-up for Complications and Recovery

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

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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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