Clinical Trials Logo
  1. Home
  2. Hysteroscopy
  3. NCT02142673

The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain.

Hysteroscopy Clinical Trial

Official title:
The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain. A Randomized Double Blind Controlled Trial

Clinical Trial Summary

The study aims to compare different filling pressures in operative outpatient hysteroscopy. Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40mmHg in group 3.

Clinical Trial Description

240 women will be randomly divided into 3 groups, each containing 80 women. Randomisation will be performed using a computer generated random numbers and sealed envelopes.

Full history will be taken followed by general and local examination. One hour before the procedure all women will receive diclofenac 100mg (Voltaren@ Novartis Switzerland). The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40 mmHg in group 3. Randomisation will be double blind, neither the operator nor the patient will know the pressure during the procedure, a third party will set the pressure according to the computer generated random numbers. If the procedure cannot be completed, the operator will ask for the pressure to be adjusted to 80mm Hg, which is the usual pressure used in Cairo university hospitals, or more if needed. In this case the operator will document in the data collection form that the procedure could not be completed with the pre-set pressure.

The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 50Charr Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors Tecchno medical GmbH. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02142673
Study type Interventional
Source Cairo University
Contact
Status Completed
Phase N/A
Start date May 2014
Completion date July 2016
View Details
See also
  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 NCT05540379 - Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence N/A
Completed NCT04462835 - Feasibility, Effectiveness and Safety of Outpatient Hysteroscopy
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 NCT02736071 - Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy Phase 3
Recruiting NCT02736019 - Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women 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