HysteroscopyNCT02142673
The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain.
A study testing Filling pressure 80, Filling pressure 60 and Filling pressure 40 in people with Hysteroscopy, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to compare different filling pressures in operative outpatient hysteroscopy. Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40mmHg in group 3. 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 60 and Filling pressure 40
- 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 Jul 2016
- 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
- Indication to have an operative outpatient hysteroscopy like endometrial polyp, need for endometrial biopsy, intrauterine adhesions, intra uterine device (IUD) retrieval or intrauterine septum resection.
- Consents to participate in the study
Who cannot join
- Premenstrual and mid-menstrual patients.
- Patients with missed periods.
- Patients with known cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain. A Randomized Double Blind Controlled Trial
The study aims to compare different filling pressures in operative outpatient hysteroscopy. Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40mmHg in group 3.
Read the detailed description
240 women will be randomly divided into 3 groups, each containing 80 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. One hour before the procedure all women will receive diclofenac 100mg (Voltaren@ Novartis Switzerland). 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 80mm Hg in group1, 60mm Hg in group 2 and 40 mmHg 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. If the procedure cannot be completed, the operator will ask for the pressure to be adjusted to 80mm Hg, which is the usual pressure used in Cairo university hospitals, or more if needed. In this case the operator will document in the data collection form that the procedure could not be completed with the pre-set pressure.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 50Charr Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors Tecchno medical GmbH.
- Conditions
- Hysteroscopy
- Being tested
- Filling pressure 80, Filling pressure 60, Filling pressure 40
- Keywords
- Operative hysteroscopy, Filling pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling pressure 80Device
The hysteroscope filling pressure will be 80mm Hg
Filling pressure 60Device
The hysteroscope filling pressure will be reduced to 50mm Hg
Filling pressure 40Device
The hysteroscope filling pressure will be 40mm Hg
| Study group | Role | What they receive |
|---|---|---|
| Filling pressure 80 | Active comparator | The hysteroscope filling pressure will be 80mm Hg Receives: Device: Filling pressure 80 |
| Filling pressure 60 | Active comparator | The hysteroscope filling pressure will be to 50mm Hg Receives: Device: Filling pressure 60 |
| Filling pressure 40 | Active comparator | The hysteroscope filling pressure will be to 40mm Hg Receives: Device: Filling pressure 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completing the procedure with the allocated pressure
The operator will document if he is able to complete the operative procedure with the allocated pressure. If the operator is not able to operate with the allocation pressure, he will document that the procedure cannot be completed with the current pressure and will ask for the filling pressure to be adjusted
Measured: 30 minutes after starting the procedure
Secondary outcomes (2)
Pain perception during the procedure
Pain will be assessed using a visual analogue scale 10 minutes after starting the procedure
Measured: 10 minutes after starting the procedure
Pain perception after the procedure
Pain will be assessed using a visual analogue scale 30 minutes after completing the procedure
Measured: 30 minutes after completing 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 completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 MA Hassan, MRCOG, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142673
- Sponsor's protocol ID
- Hyst 2
- Status last verified
- Aug 2016
- First submitted
- 16 May 2014
- Last updated
- 3 Aug 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 24262433Haggag H, Hassan A, Wahba A, Joukhadar R. A randomized double-blind controlled trial of different filling pressures in operative outpatient hysteroscopy. Int J Gynaecol Obstet. 2017 Oct;139(1):55-60. doi: 10.1002/ijgo.12247. Epub 2017 Jul 25.
PubMed 28653328
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain. A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02142673
- Acronym / sponsor ID
- Hyst 2
- Conditions
- Hysteroscopy
- Keywords
- Operative hysteroscopy, Filling pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (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 study aims to compare different filling pressures in operative outpatient hysteroscopy. Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40mmHg in group 3.
Detailed description
240 women will be randomly divided into 3 groups, each containing 80 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. One hour before the procedure all women will receive diclofenac 100mg (Voltaren@ Novartis Switzerland). 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 80mm Hg in group1, 60mm Hg in group 2 and 40 mmHg 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. If the procedure cannot be completed, the operator will ask for the pressure to be adjusted to 80mm Hg, which is the usual pressure used in Cairo university hospitals, or more if needed. In this case the operator will document in the data collection form that the procedure could not be completed with the pre-set pressure.
The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 50Charr Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors Tecchno medical GmbH.
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 80The hysteroscope filling pressure will be 80mm Hg |
| Filling pressure 60 | Active comparator | Device: Filling pressure 60The hysteroscope filling pressure will be to 50mm Hg |
| Filling pressure 40 | Active comparator | Device: Filling pressure 40The hysteroscope filling pressure will be to 40mm 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
- Indication to have an operative outpatient hysteroscopy like endometrial polyp, need for endometrial biopsy, intrauterine adhesions, intra uterine device (IUD) retrieval or intrauterine septum resection.
- Consents to participate in the study
Key exclusion criteria (3 listed)
- Premenstrual and mid-menstrual patients.
- Patients with missed periods.
- Patients with known cardiac disease.
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 80The hysteroscope filling pressure will be 80mm Hg | Device | Filling pressure 80 |
| Filling pressure 60The hysteroscope filling pressure will be reduced to 50mm Hg | Device | Filling pressure 60 |
| Filling pressure 40The hysteroscope filling pressure will be 40mm Hg | Device | Filling pressure 40 |
Primary outcome
Completing the procedure with the allocated pressure
Time frame: 30 minutes after starting the procedure
The operator will document if he is able to complete the operative procedure with the allocated pressure. If the operator is not able to operate with the allocation pressure, he will document that the procedure cannot be completed with the current pressure and will ask for the filling pressure to be adjusted
2 secondary outcomes
Pain perception during the procedure
Time frame: 10 minutes after starting the procedure
Pain perception after the procedure
Time frame: 30 minutes after completing 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 3 Aug 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.
- Derived from this study: PubMed 28653328Haggag H, Hassan A, Wahba A, Joukhadar R. A randomized double-blind controlled trial of different filling pressures in operative outpatient hysteroscopy. Int J Gynaecol Obstet. 2017 Oct;139(1):55-60. doi: 10.1002/ijgo.12247. Epub 2017 Jul 25.
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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 MA 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 60 and Filling pressure 40 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 3 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 3 Aug 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?
Completing the procedure with the allocated pressure (time frame: 30 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 NCT02142673, which also lists 5 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 3 Aug 2016.