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Pain in Different Office Hysteroscopy Diameter

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ClinicalTrials.gov Identifier: NCT02939196
Recruitment Status : Unknown
Verified July 2017 by Essam Rashad Abdel-Hafeez Othman, Assiut University.
Recruitment status was:  Recruiting
First Posted : October 19, 2016
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Essam Rashad Abdel-Hafeez Othman, Assiut University

Brief 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.


Condition or disease Intervention/treatment
Pain Associated Office Hysteroscopy 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


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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Pain Accompanying the Use of 3.7 mm and 4 mm Office Hysteroscopy in Nullipara: A Randomized Clinical Trial
Study Start Date : November 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

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




Primary Outcome Measures :
  1. Pain more than 4 (according visual analogue scale [ Time Frame: 5 minute ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   because hysteroscopy done only in female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
female patent between 20 to 45 years old who under go office hysteroscopy
Criteria

Inclusion Criteria:

  • Woman with nulliparous cervix

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939196


Contacts
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Contact: Essam Othman, MD essamrash@yahoo.com

Locations
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Egypt
Essam Othman Recruiting
Assiut, Cairo, Egypt, Egypt, 002
Contact: Essam Othman, MD    002      
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Essam Othman, MD Assiut

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Responsible Party: Essam Rashad Abdel-Hafeez Othman, Associate Professor, OB-GYN department-principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT02939196     History of Changes
Other Study ID Numbers: OH
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No