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 Details — Status: Completed

Administrative data

• NCT number: NCT02142673
• Other study ID #: Hyst 2
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: August 2, 2016
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: August 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

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
The hysteroscope filling pressure will be 80mm Hg
• Filling pressure 60
The hysteroscope filling pressure will be reduced to 50mm Hg
• Filling pressure 40
The hysteroscope filling pressure will be 40mm Hg

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	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	No
Secondary	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	No
Secondary	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	No