Pain in Different Office Hysteroscopy Diameter

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain Associated Office Hysteroscopy
• Intervention / Treatment: Procedure: office hysteroscopy 3.7; Procedure: office hysteroscopy 4

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Cairo, Egypt, Egypt, 002
    • Recruiting
    • Essam Othman
    • Contact: Essam Othman, MD; Phone Number: 002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

female patent between 20 to 45 years old who under go office hysteroscopy

Description

Inclusion Criteria:

• Woman with nulliparous cervix

Exclusion Criteria:

• Pregnancy.
• female genital cancer
• Active pelvic infection
• Multipara
• patient not receiving misoprostol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group(A); 2.7 mm rigid hysteroscopy.	Procedure: office hysteroscopy 3.7; office hysteroscopy with a 3.7 -mm outer sheath
Group(B); 2.9 mm rigid hysteroscopy.	Procedure: office hysteroscopy 4; office hysteroscopy with a4-mm outer sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain more than 4 (according visual analogue scale	5 minute

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Essam Othman, MD, Assiut

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (ESTIMATE): October 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO