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

Study Overview
=================
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.

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

Conditions
-----------------
Hysteroscopy

Intervention / Treatment
-----------------
* Device: Filling pressure 80
* Device: Filling pressure 60
* Device: Filling pressure 40


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filling pressure 80<br>The hysteroscope filling pressure will be 80mm Hg | Device: Filling pressure 80<br>* The hysteroscope filling pressure will be 80mm Hg<br>|
| Active Comparator: Filling pressure 60<br>The hysteroscope filling pressure will be to 50mm Hg | Device: Filling pressure 60<br>* The hysteroscope filling pressure will be reduced to 50mm Hg<br>|
| Active Comparator: Filling pressure 40<br>The hysteroscope filling pressure will be to 40mm Hg | Device: Filling pressure 40<br>* The hysteroscope filling pressure will be 40mm Hg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completing the procedure with the allocated pressure | 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 | 30 minutes after starting the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception during the procedure | Pain will be assessed using a visual analogue scale 10 minutes after starting the procedure | 10 minutes after starting the procedure | 
| Pain perception after the procedure | Pain will be assessed using a visual analogue scale 30 minutes after completing the procedure | 30 minutes after completing the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Operative hysteroscopy, Filling pressure