HysteroscopyFESHANCT04462835
Feasibility, Effectiveness and Safety of Outpatient Hysteroscopy
An observational study of Hysteroscopy and Outpatient, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysteroscopy, Outpatient
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2020to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who attended an ambulatory hysteroscopy in our centre.
Who may be able to join
- All the patients who attended an ambulatory hysteroscopy in our centre.
Who cannot join
- There were not any exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Hysteroscopy, Outpatient
- Keywords
- Hysteroscopy, outpatient, Gold standard
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: proportion of hysteroscopies that could be satisfactorily performed
Feasibility refers to the proportion of hysteroscopies that could be satisfactorily performed
Measured: 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
Measured: 3 months
Safety: Percentage of complications registered
Percentage of complications registered.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 May 2020
- Primary completion30 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Simo Gonzalez, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462835
- Sponsor's protocol ID
- IIBSP-FES-2019-96
- Acronym
- FESHA
- Status last verified
- Aug 2020
- First submitted
- 6 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bakour SH, Jones SE, O'Donovan P. Ambulatory hysteroscopy: evidence-based guide to diagnosis and therapy. Best Pract Res Clin Obstet Gynaecol. 2006 Dec;20(6):953-75. doi: 10.1016/j.bpobgyn.2006.06.004. Epub 2006 Nov 20.
PubMed 17116420Capmas P, Pourcelot AG, Giral E, Fedida D, Fernandez H. Office hysteroscopy: A report of 2402 cases. J Gynecol Obstet Biol Reprod (Paris). 2016 May;45(5):445-50. doi: 10.1016/j.jgyn.2016.02.007. Epub 2016 Apr 4.
PubMed 27055773Bennett A, Lepage C, Thavorn K, Fergusson D, Murnaghan O, Coyle D, Singh SS. Effectiveness of Outpatient Versus Operating Room Hysteroscopy for the Diagnosis and Treatment of Uterine Conditions: A Systematic Review and Meta-Analysis. J Obstet Gynaecol Can. 2019 Jul;41(7):930-941. doi: 10.1016/j.jogc.2018.10.002. Epub 2018 Dec 7.
PubMed 30528838Krins T. Outpatient hysteroscopy. Aust N Z J Obstet Gynaecol. 2017 Oct;57(5):E10. doi: 10.1111/ajo.12662. No abstract available.
PubMed 28967691Diwakar L, Roberts TE, Cooper NA, Middleton L, Jowett S, Daniels J, Smith P, Clark TJ; OPT trial collaborative group. An economic evaluation of outpatient versus inpatient polyp treatment for abnormal uterine bleeding. BJOG. 2016 Mar;123(4):625-31. doi: 10.1111/1471-0528.13434. Epub 2015 May 25.
PubMed 26011792Campo R, Santangelo F, Gordts S, Di Cesare C, Van Kerrebroeck H, De Angelis MC, Di Spiezio Sardo A. Outpatient hysteroscopy. Facts Views Vis Obgyn. 2018 Sep;10(3):115-122.
PubMed 31191845
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Effectiveness and Safety of 3000 Hysteroscopies in Outpatient Setting
- ClinicalTrials.gov ID
- NCT04462835
- Acronym / sponsor ID
- FESHA / IIBSP-FES-2019-96
- Conditions
- Hysteroscopy, Outpatient
- Keywords
- Hysteroscopy, outpatient, Gold standard
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who attended an ambulatory hysteroscopy in our centre.
Key inclusion criteria (1 listed)
- All the patients who attended an ambulatory hysteroscopy in our centre.
Key exclusion criteria (1 listed)
- There were not any exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Safety: Percentage of complications registered
Time frame: 3 months
Percentage of complications registered.
1 secondary outcome
Pain during the hysteroscopy and 10 minutes later: Verbal Numerical Rating Scale (VNRS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Background: PubMed 17116420Bakour SH, Jones SE, O'Donovan P. Ambulatory hysteroscopy: evidence-based guide to diagnosis and therapy. Best Pract Res Clin Obstet Gynaecol. 2006 Dec;20(6):953-75. doi: 10.1016/j.bpobgyn.2006.06.004. Epub 2006 Nov 20.
- Background: PubMed 27055773Capmas P, Pourcelot AG, Giral E, Fedida D, Fernandez H. Office hysteroscopy: A report of 2402 cases. J Gynecol Obstet Biol Reprod (Paris). 2016 May;45(5):445-50. doi: 10.1016/j.jgyn.2016.02.007. Epub 2016 Apr 4.
- Background: PubMed 30528838Bennett A, Lepage C, Thavorn K, Fergusson D, Murnaghan O, Coyle D, Singh SS. Effectiveness of Outpatient Versus Operating Room Hysteroscopy for the Diagnosis and Treatment of Uterine Conditions: A Systematic Review and Meta-Analysis. J Obstet Gynaecol Can. 2019 Jul;41(7):930-941. doi: 10.1016/j.jogc.2018.10.002. Epub 2018 Dec 7.
- Background: PubMed 28967691Krins T. Outpatient hysteroscopy. Aust N Z J Obstet Gynaecol. 2017 Oct;57(5):E10. doi: 10.1111/ajo.12662. No abstract available.
- Background: PubMed 26011792Diwakar L, Roberts TE, Cooper NA, Middleton L, Jowett S, Daniels J, Smith P, Clark TJ; OPT trial collaborative group. An economic evaluation of outpatient versus inpatient polyp treatment for abnormal uterine bleeding. BJOG. 2016 Mar;123(4):625-31. doi: 10.1111/1471-0528.13434. Epub 2015 May 25.
- Background: PubMed 31191845Campo R, Santangelo F, Gordts S, Di Cesare C, Van Kerrebroeck H, De Angelis MC, Di Spiezio Sardo A. Outpatient hysteroscopy. Facts Views Vis Obgyn. 2018 Sep;10(3):115-122.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Simo Gonzalez principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysteroscopy and Outpatient, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: proportion of hysteroscopies that could be satisfactorily performed (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462835, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.