Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy

Hysteroscopy Clinical Trial

Official title:

Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy: A Double Blinded Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142686
• Other study ID #: Hyst 1
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: January 26, 2016
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare different filling pressures

Description:

This study is a prospective double blinded randomised controlled trial. 240 women will be randomly divided into 3 groups, each containing 70 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. 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 set at 80mm Hg until the hysteroscope is introduced in the uterine cavity. After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg in group1, will be reduced to 50mm Hg in group 2 and to 30mmHg 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.

The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 years

• Has a clear Indication to have an outpatient hysteroscopy

• Consent to participate in the study

Exclusion Criteria:

• Premenstrual and midmenstrual patients.

• Patients with missed periods.

• Patients with known cardiac disease.

• Patients who need operative hysteroscopy

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

• Hysteroscopy

Intervention

Device:
• Filling pressure 80
After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.
• Filling pressure 50
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.
• Filling pressure 30
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015. Review. — View Citation

Shahid A, Pathak M, Gulumser C, Parker S, Palmer E, Saridogan E. Optimum uterine filling pressure for outpatient diagnostic hysteroscopy: a double-blind, randomized controlled trial. Reprod Biomed Online. 2014 Jan;28(1):86-91. doi: 10.1016/j.rbmo.2013.07.018. Epub 2013 Sep 14. — View Citation

Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52. doi: 10.4103/0019-5359.53394. — View Citation

van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adequate visualization of the uterine cavity	10 minutes after starting the procedure, the operator will document if adequate visualization was achieved using the allocated pressure. If visualization was not adequate, he will document that adequate visualization was not achieved using the allocated pressure and will ask for the pressure to be adjusted.	10 minutes after starting the procedure.	No
Secondary	Pain perceived by the patient	Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.	10 minutes after starting the procedure	No
Secondary	Pain perceived by the patient 30 minutes after starting the procedure.	Pain will be assessed by a visual analogue scale 30 minutes after starting the procedure.	30 minutes after starting the procedure.	No