Feasibility, Effectiveness and Safety of Outpatient Hysteroscopy

Study Overview
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Brief Summary
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Study Objective: The main objective of the study is to assess the feasibility, effectiveness and safety of outpatient hysteroscopies performed in our Office Hysteroscopy Unit. Design: Retrospective observational study of prospectively collected data from the Office Hysteroscopy Unit database. Setting: Tertiary care university hospital Patients: Three thousand patients who consecutively attended an ambulatory hysteroscopy in our centre from may 2008 to october 2019 Interventions: The Office hysteroscopy was performed with several rigid 5-6 mm diameter devices when indicated with a diagnostic and/or therapeutic purpose

Detailed Description
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Retrospective observational study of our prospectively collected database of 3000 consecutive hysteroscopies performed from may 2008 to october 2019 in our Office Hysteroscopy Unit (OHU). All the patients who attended an ambulatory hysteroscopy in our centre during the study period were included. There were not any exclusion criteria and all data were prospectively collected in a computer database. The primary endpoint was to determine the main results of the Outpatient Hysteroscopy Unit in terms of feasibility, effectiveness and safety. Feasibility was defined as the proportion of explorations that could be satisfactorily performed. Effectiveness was evaluated through the percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment. Safety was assessed as the percentage of complications registered. In addition, we registered the intensity of the pain perceived by the patient with a Verbal Numerical Rating Scale (VNRS) (from 0 to 10) during the procedure and ten minutes later. All the hysteroscopies were performed in our Office Hysteroscopy Unit by three experienced gynaecologists who performed the hysteroscopy assisted by a nurse. For pain and anxiety management, a painkiller (ibuprofen 600 mg) and an anxiolytic (diazepam 5 mg) were orally dispensed to all patients 30 minutes before the procedure. Cervical preparation with Misoprostol (400 mcg, intravaginal administration 4-6 hours before the test) was administered only in cases of anticipated or previous failed cervical passage. Paracervical anaesthesia was administered in selected cases of several pain during the passage through the cervical canal. Premenopausal women were asked to take desogestrel 75 mg, at least 30 days prior to the procedure for endometrial preparation and if the patient was unwilling to take the medication, the procedure was preferably performed in the early follicular phase. Hysteroscopy was performed with the several diagnostic and therapeutic rigid devices available in our Office Hysteroscopy Unit in 5-6 mm diameter: mechanical instruments (scissors and forceps), bipolar electrode (Versapoint ®), bipolar Gubini resector (Colibrí®) and mechanical morcelators (Myosure® and Truclear®), They have been set up gradually in our Unit. Saline solution 0.9% was used as a distention media with an automated pressure delivery system and he vaginoscopic approach was performed.

Official Title
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Feasibility, Effectiveness and Safety of 3000 Hysteroscopies in Outpatient Setting

Conditions
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Hysteroscopy, Outpatient

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients who attended an ambulatory hysteroscopy in our centre. Exclusion Criteria: There were not any exclusion criteria.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: proportion of hysteroscopies that could be satisfactorily performed | Feasibility refers to the proportion of hysteroscopies that could be satisfactorily performed | 3 months | 
| Efectiveness: Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment | Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment | 3 months | 
| Safety: Percentage of complications registered | Percentage of complications registered. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the hysteroscopy and 10 minutes later: Verbal Numerical Rating Scale (VNRS) | The intensity of the pain perceived by the patient with a Verbal Numerical Rating Scale (VNRS) (from 0 which is no pain to 10 which is the worst pain ever imagined) during the procedure and ten minutes later. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysteroscopy, outpatient, Gold standard