CHI Créteil - Gynécologie et obstétrique
Créteil, 94000, France
Location status: Recruiting
NCT Number: NCT07146659
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Créteil, 94000, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-⁃ Undergoing operative hysteroscopy for intrauterine pathology
Exclusion criteria
Time frame: The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)
Time frame: During the procedure (if the patient is awake), immediately after the procedure, and at hospital discharge (baseline)
Time frame: At hospital discharge.(assessed up to 5 days)
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.
Time frame: Up to 8 weeks postoperatively.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Intercommunal Creteil
Other
Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings : A Prospective Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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