Pain in Different Office Hysteroscopy Diameter

Pain Associated Office Hysteroscopy Clinical Trial

Official title:

Comparison of Pain Accompanying the Use of 3.7 mm and 4 mm Office Hysteroscopy in Nullipara: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02939196
• Other study ID #: OH
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2016
• Last updated: July 19, 2017
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: Essam Othman, MD
• Email: essamrash[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the investigators'study was To compare 2 different diameter rigid hysteroscopy in vaginoscopic approach regarding pain during and after the procedure.

And to evaluate patient acceptability and tolerability in order to determine the best way to perform hysteroscopy in an outpatient setting.

Description:

Office hysteroscopy is used as diagnostic tool to investigate abnormal uterine bleeding and other diseases involving the uterine cavity one of The main limitation to its widespread use is feared from pain and low patient tolerability Narrower diameter hysteroscopy and endometrial biopsy devices are being developed to improve the acceptability of office hysteroscopy. Miniature optical systems allow performance of most diagnostic and operative hysteroscopy (after proper patient selection) in an outpatient or office setting .Flexible hysteroscopy seem to be less painful at the beginning and during the procedure ,but the optical qualities are poor Hysteroscopy is safe, feasible and accurate procedure for diagnosing intrauterine pathology.

Provision of outpatient based diagnostic and operative services are gaining prominence as a standard of cure but the experience of pain can be off-putting for patients having outpatient diagnostic hysteroscopy.

saline solution is an excellent alternative to carbon dioxide in women undergoing outpatient hysteroscopy, and there are fewer complications

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Woman with nulliparous cervix

Exclusion Criteria:

• Pregnancy.

• female genital cancer

• Active pelvic infection

• Multipara

• patient not receiving misoprostol

Related Conditions & MeSH terms

• Pain Associated Office Hysteroscopy

Intervention

Procedure:
• office hysteroscopy 3.7
office hysteroscopy with a 3.7 -mm outer sheath
• office hysteroscopy 4
office hysteroscopy with a4-mm outer sheath

Locations

Country	Name	City	State
Egypt	Essam Othman	Assiut, Cairo, Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain more than 4 (according visual analogue scale		5 minute