Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Hospitalier Intercommunal Creteil
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged ≥ 18 years
Able to provid e informed non-opposition
French-speaking
Disqualifiers
Patients with contraindications to hysteroscopy
Pregnancy
Inability to complete follow-up
Trial population
Adult women requiring operative hysteroscopy for intrauterine pathology
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Operative hysteroscopy in the operating room
Group B: Operative hysteroscopy in the outpatient setting
Trial outcomes
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.
Time frame
The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)Secondary outcomes
1
Perioperative and postoperative pain Assessed using the Visual Analogue Scale (VAS)
Time frame
During the procedure (if the patient is awake), immediately after the procedure, and at hospital discharge (baseline)2
Patient satisfaction Assessed using a locally developed patient satisfaction questionnaire
Time frame
At hospital discharge.(assessed up to 5 days)3
Complications including uterine perforation, hemorrhage, and postoperative infection
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.4
4. Time to return to work Measured as the number of days of sick leave prescribed and actually taken.
Time frame
Up to 8 weeks postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov