NCT04462835

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

July 6, 2020

Last Update Submit

August 17, 2020

Conditions

HysteroscopyOutpatient

Keywords

HysteroscopyoutpatientGold standard

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Pain during the hysteroscopy and 10 minutes later: Verbal Numerical Rating Scale (VNRS)

    3 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who attended an ambulatory hysteroscopy in our centre.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (6)

  • 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.

    PMID: 17116420BACKGROUND

  • Capmas 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.

    PMID: 27055773BACKGROUND

  • Bennett 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.

    PMID: 30528838BACKGROUND

  • Krins T. Outpatient hysteroscopy. Aust N Z J Obstet Gynaecol. 2017 Oct;57(5):E10. doi: 10.1111/ajo.12662. No abstract available.

    PMID: 28967691BACKGROUND

  • Diwakar 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.

    PMID: 26011792BACKGROUND

  • Campo 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.

    PMID: 31191845BACKGROUND

Study Officials

  • Marta Simo Gonzalez

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 8, 2020

Study Start

May 1, 2020

Primary Completion

July 30, 2020

Study Completion

August 1, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

ES(1)