Hysteroscopy Clinical Trial
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
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05514236 -
Effect of Virtual Reality and Music Therapy on Pain Relief in Outpatient Hysteroscopy
|
N/A | |
Completed |
NCT06092541 -
Pericervical Analgesia Versus Analesia With Nitrous Oxide (N2O) in Outpatien Operative Hysteroscopy With Miniresector
|
N/A | |
Not yet recruiting |
NCT05069077 -
the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women
|
N/A | |
Completed |
NCT03701984 -
The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy
|
Phase 4 | |
Not yet recruiting |
NCT05069025 -
Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients
|
N/A | |
Completed |
NCT04166500 -
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
|
N/A | |
Not yet recruiting |
NCT06379841 -
Green Hysteroscopy
|
N/A | |
Completed |
NCT02863679 -
Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel
|
N/A | |
Completed |
NCT02142686 -
Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy
|
N/A | |
Completed |
NCT02142673 -
The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain.
|
N/A | |
Completed |
NCT05540379 -
Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence
|
N/A | |
Recruiting |
NCT04862598 -
Virtual Reality to Improve Satisfaction in Hysteroscopy Patients
|
N/A | |
Recruiting |
NCT01376934 -
Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques
|
N/A | |
Not yet recruiting |
NCT06172140 -
Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy
|
N/A | |
Recruiting |
NCT03409835 -
Effect of Ramosetron on Post-discharge Nausea and Vomiting
|
N/A | |
Enrolling by invitation |
NCT03579550 -
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus
|
N/A | |
Recruiting |
NCT02736019 -
Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women
|
Phase 3 | |
Recruiting |
NCT02736071 -
Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy
|
Phase 3 | |
Not yet recruiting |
NCT05858931 -
Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects
|
||
Completed |
NCT04232930 -
The Use of Music in Reducing Pain During Outpatient Hysteroscopy
|
N/A |