HysteroscopyNCT02142686
Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy
A study testing Filling pressure 80, Filling pressure 50 and Filling pressure 30 in people with Hysteroscopy, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare different filling pressures Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Filling pressure 80, Filling pressure 50 and Filling pressure 30
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Apr 2015
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Has a clear Indication to have an outpatient hysteroscopy
- Consent to participate in the study
Who cannot join
- Premenstrual and midmenstrual patients.
- Patients with missed periods.
- Patients with known cardiac disease.
- Patients who need operative hysteroscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy: A Double Blinded Randomised Controlled Trial.
The aim of this study is to compare different filling pressures
Read the detailed description
This study is a prospective double blinded randomised controlled trial. 240 women will be randomly divided into 3 groups, each containing 70 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. 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 set at 80mm Hg until the hysteroscope is introduced in the uterine cavity. After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg in group1, will be reduced to 50mm Hg in group 2 and to 30mmHg 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.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
- Conditions
- Hysteroscopy
- Being tested
- Filling pressure 80, Filling pressure 50, Filling pressure 30
- Keywords
- Hysteroscopy, Filling pressures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling pressure 80Device
After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.
Filling pressure 50Device
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.
Filling pressure 30Device
After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm
| Study group | Role | What they receive |
|---|---|---|
| Filling pressure 80 | Active comparator | After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm. Receives: Device: Filling pressure 80 |
| Filling pressure 50. | Active comparator | After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg in this group Receives: Device: Filling pressure 50 |
| illing pressure 30 | Active comparator | After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm Hg. Receives: Device: Filling pressure 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate visualization of the uterine cavity
10 minutes after starting the procedure, the operator will document if adequate visualization was achieved using the allocated pressure. If visualization was not adequate, he will document that adequate visualization was not achieved using the allocated pressure and will ask for the pressure to be adjusted.
Measured: 10 minutes after starting the procedure.
Secondary outcomes (2)
Pain perceived by the patient
Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.
Measured: 10 minutes after starting the procedure
Pain perceived by the patient 30 minutes after starting the procedure.
Pain will be assessed by a visual analogue scale 30 minutes after starting the procedure.
Measured: 30 minutes after starting the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdelGany Hassan, Cairo University
- Investigators
- AbdelGany M A Hassan, MRCOG, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142686
- Sponsor's protocol ID
- Hyst 1
- Status last verified
- Jan 2016
- First submitted
- 16 May 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19602758van 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. doi: 10.1111/j.1471-0528.2007.01326.x.
PubMed 17516956O'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.
PubMed 20926175Shahid 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.
PubMed 24262433
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy: A Double Blinded Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02142686
- Acronym / sponsor ID
- Hyst 1
- Conditions
- Hysteroscopy
- Keywords
- Hysteroscopy, Filling pressures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 May 2014 (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 aim of this study is to compare different filling pressures
Detailed description
This study is a prospective double blinded randomised controlled trial. 240 women will be randomly divided into 3 groups, each containing 70 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. 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 set at 80mm Hg until the hysteroscope is introduced in the uterine cavity. After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg in group1, will be reduced to 50mm Hg in group 2 and to 30mmHg 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.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Filling pressure 80 | Active comparator | Device: Filling pressure 80After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm. |
| Filling pressure 50. | Active comparator | Device: Filling pressure 50After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg in this group |
| illing pressure 30 | Active comparator | Device: Filling pressure 30After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm Hg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- Has a clear Indication to have an outpatient hysteroscopy
- Consent to participate in the study
Key exclusion criteria (4 listed)
- Premenstrual and midmenstrual patients.
- Patients with missed periods.
- Patients with known cardiac disease.
- Patients who need operative hysteroscopy
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 |
|---|---|---|
| Filling pressure 80After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg. | Device | Filling pressure 80 |
| Filling pressure 50After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg. | Device | Filling pressure 50. |
| Filling pressure 30After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm | Device | illing pressure 30 |
Primary outcome
adequate visualization of the uterine cavity
Time frame: 10 minutes after starting the procedure.
10 minutes after starting the procedure, the operator will document if adequate visualization was achieved using the allocated pressure. If visualization was not adequate, he will document that adequate visualization was not achieved using the allocated pressure and will ask for the pressure to be adjusted.
2 secondary outcomes
Pain perceived by the patient
Time frame: 10 minutes after starting the procedure
Pain perceived by the patient 30 minutes after starting the procedure.
Time frame: 30 minutes after starting the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Background: PubMed 19602758Sharma 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.
- Background: PubMed 17516956van 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. doi: 10.1111/j.1471-0528.2007.01326.x.
- Background: PubMed 20926175O'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.
- Background: PubMed 24262433Shahid 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.
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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.
AbdelGany M A Hassan, MRCOG, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filling pressure 80, Filling pressure 50 and Filling pressure 30 in people with Hysteroscopy, run by Cairo 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate visualization of the uterine cavity (time frame: 10 minutes after starting the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02142686, which also lists 4 linked publications.
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 27 Jan 2016.