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

Not Applicable

Completed

• Conditions: Hysteroscopy
• Interventions: Device: Filling pressure 60; Device: Filling pressure 80; Device: Filling pressure 40

• Registration Number: NCT02142673
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Age 18-60 years
• Indication to have an operative outpatient hysteroscopy like endometrial polyp, need for endometrial biopsy, intrauterine adhesions, intra uterine device (IUD) retrieval or intrauterine septum resection.
• Consents to participate in the study

Exclusion Criteria

• Premenstrual and mid-menstrual patients.
• Patients with missed periods.
• Patients with known cardiac disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filling pressure 60	Filling pressure 60	The hysteroscope filling pressure will be to 50mm Hg
Filling pressure 80	Filling pressure 80	The hysteroscope filling pressure will be 80mm Hg
Filling pressure 40	Filling pressure 40	The hysteroscope filling pressure will be to 40mm Hg

Primary Outcome Measures

Name	Time	Method
Completing the procedure with the allocated pressure	30 minutes after starting the procedure	The operator will document if he is able to complete the operative procedure with the allocated pressure. If the operator is not able to operate with the allocation pressure, he will document that the procedure cannot be completed with the current pressure and will ask for the filling pressure to be adjusted

Secondary Outcome Measures

Name	Time	Method
Pain perception during the procedure	10 minutes after starting the procedure	Pain will be assessed using a visual analogue scale 10 minutes after starting the procedure
Pain perception after the procedure	30 minutes after completing the procedure	Pain will be assessed using a visual analogue scale 30 minutes after completing the procedure

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt