Feasibility, Effectiveness and Safety of Outpatient Hysteroscopy (FESHA)

August 17, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Feasibility, Effectiveness and Safety of 3000 Hysteroscopies in Outpatient Setting

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who attended an ambulatory hysteroscopy in our centre.

Description

Inclusion Criteria:

  • All the patients who attended an ambulatory hysteroscopy in our centre.

Exclusion Criteria:

  • There were not any exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: proportion of hysteroscopies that could be satisfactorily performed
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Marta Simo Gonzalez, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIBSP-FES-2019-96

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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