Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings

NCT07146659 | Recruiting

• 1 other identifier: HOPE
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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 to work.

Conditions

Fibroid Uterus; Polyp Uterus; Retained Products of Conception

Keywords

Hysteroscopy; Operative hysteroscopy; Outpatient ambulatory; Patient satisfaction; Outpatient hysteroscopy; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women requiring operative hysteroscopy for intrauterine pathology

You may qualify if:

• Women aged ≥ 18 years
• ⁃ Undergoing operative hysteroscopy for intrauterine pathology
• Able to provid e informed non-opposition
• French-speaking

You may not qualify if:

• Patients with contraindications to hysteroscopy
• Pregnancy
• Inability to complete follow-up

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

CHI Créteil - Gynécologie et obstétrique

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Yann SALHI, MD

CONTACT

0157022000; yann.salhi@chicreteil.fr

Elie MOSNINO, MD

CONTACT

elie.mosnino@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 28, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-07

Locations

FR (1)