Pain Associated Office HysteroscopyNCT02939196
Pain in Different Office Hysteroscopy Diameter
An observational study of Pain Associated Office Hysteroscopy, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pain Associated Office Hysteroscopy
- What is being tested?
- office hysteroscopy 3.7 and office hysteroscopy 4
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: female patent between 20 to 45 years old who under go office hysteroscopy
Who may be able to join
- Woman with nulliparous cervix
Who cannot join
- Pregnancy.
- female genital cancer
- Active pelvic infection
- Multipara
- patient not receiving misoprostol
Trial locations and contacts
1 site in 1 country.
Essam Othman, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Essam Othman
Assiut, Cairo, Egypt, 002
Essam Othman, MD, 002
About this study
Official title: 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.
Read the 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
- Conditions
- Pain Associated Office Hysteroscopy
- Being tested
- office hysteroscopy 3.7, office hysteroscopy 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office hysteroscopy 3.7Procedure or surgery
office hysteroscopy with a 3.7 -mm outer sheath
office hysteroscopy 4Procedure or surgery
office hysteroscopy with a4-mm outer sheath
| Study group | Role | What they receive |
|---|---|---|
| Group(A) | 2.7 mm rigid hysteroscopy. Receives: Procedure: office hysteroscopy 3.7 | |
| Group(B) | 2.9 mm rigid hysteroscopy. Receives: Procedure: office hysteroscopy 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain more than 4 (according visual analogue scale
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Associated Office HysteroscopyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam Rashad Abdel-Hafeez Othman, Assiut University
- Investigators
- Essam Othman, MD, Principal investigator, Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939196
- Sponsor's protocol ID
- OH
- Status last verified
- Jul 2017
- First submitted
- 18 Oct 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Accompanying the Use of 3.7 mm and 4 mm Office Hysteroscopy in Nullipara: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02939196
- Acronym / sponsor ID
- OH
- Conditions
- Pain Associated Office Hysteroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group(A) | – | Procedure: office hysteroscopy 3.72.7 mm rigid hysteroscopy. |
| Group(B) | – | Procedure: office hysteroscopy 42.9 mm rigid hysteroscopy. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female patent between 20 to 45 years old who under go office hysteroscopy
Key inclusion criteria (1 listed)
- Woman with nulliparous cervix
Key exclusion criteria (5 listed)
- Pregnancy.
- female genital cancer
- Active pelvic infection
- Multipara
- patient not receiving misoprostol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| office hysteroscopy 3.7office hysteroscopy with a 3.7 -mm outer sheath | Procedure or surgery | Group(A) |
| office hysteroscopy 4office hysteroscopy with a4-mm outer sheath | Procedure or surgery | Group(B) |
Primary outcome
Pain more than 4 (according visual analogue scale
Time frame: 5 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essam Othman, MD contact
Essam Othman, MD principal investigator
Assiut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Associated Office Hysteroscopy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Essam Othman, MD (essamrash@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain more than 4 (according visual analogue scale (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.