Intrauterine DiseasesNCT01430208
A New Alternative to Traditional Hysteroscopy
A study testing resectoscopy in people with Intrauterine Diseases and Myomas, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. The development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Intrauterine Diseases, Myomas, Polyps
- What is being tested?
- resectoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Jun 2011
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women between 18-75 years of age
- endometrial polyps and/or G0 myomas smaller than 3 cm of diameter
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions
Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. The development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al. developed a mini-resectoscope feasible for "see\&treat" hysteroscopy. The objective of the study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions. The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas, randomly allocated to receive the treatment with traditional resectoscope (127 women), with mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating time, distension media delivered, dismiss time and discomfort experienced were recorded.
- Conditions
- Intrauterine Diseases, Myomas, Polyps
- Being tested
- resectoscopy
- Keywords
- endometrial pathology
- Medical subject headings
- Myoma, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resectoscopyProcedure or surgery
hysteroscopy for myomas G0 and/or polyps
| Study group | Role | What they receive |
|---|---|---|
| mini-resectoscope | Active comparator | Not described Receives: Procedure: resectoscopy |
| tradiorional resectoscope | Active comparator | Not described Receives: Procedure: resectoscopy |
| bettocchi resectoscope | Active comparator | Not described Receives: Procedure: resectoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients
Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)
Measured: sixteen months
Secondary outcomes (1)
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the treatment of intrauterine lesions larger than 1,5cm in diameter
Operating time(min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)
Measured: sixteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine DiseasesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Guido, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430208
- Sponsor's protocol ID
- HUMREP-11-0778
- Status last verified
- Sep 2011
- First submitted
- 2 Sep 2011
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ricciardi R, Lanzone A, Tagliaferri V, Di Florio C, Ricciardi L, Selvaggi L, Guido M. Using a 16-French resectoscope as an alternative device in the treatment of uterine lesions: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):160-5. doi: 10.1097/AOG.0b013e31825b9086.
PubMed 22914405
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions
- ClinicalTrials.gov ID
- NCT01430208
- Acronym / sponsor ID
- HUMREP-11-0778
- Conditions
- Intrauterine Diseases, Myomas, Polyps
- Keywords
- endometrial pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Sep 2011 (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.
Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. The development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al. developed a mini-resectoscope feasible for "see\&treat" hysteroscopy. The objective of the study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions. The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas, randomly allocated to receive the treatment with traditional resectoscope (127 women), with mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating time, distension media delivered, dismiss time and discomfort experienced were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mini-resectoscope | Active comparator | Procedure: resectoscopy |
| tradiorional resectoscope | Active comparator | Procedure: resectoscopy |
| bettocchi resectoscope | Active comparator | Procedure: resectoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women between 18-75 years of age
- endometrial polyps and/or G0 myomas smaller than 3 cm of diameter
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| resectoscopyhysteroscopy for myomas G0 and/or polyps | Procedure or surgery | bettocchi resectoscope, mini-resectoscope, tradiorional resectoscope |
Primary outcome
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients
Time frame: sixteen months
Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS)
1 secondary outcome
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the treatment of intrauterine lesions larger than 1,5cm in diameter
Time frame: sixteen months
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 8 Sep 2011.
- Derived from this study: PubMed 22914405Ricciardi R, Lanzone A, Tagliaferri V, Di Florio C, Ricciardi L, Selvaggi L, Guido M. Using a 16-French resectoscope as an alternative device in the treatment of uterine lesions: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):160-5. doi: 10.1097/AOG.0b013e31825b9086.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resectoscopy in people with Intrauterine Diseases and Myomas, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 2 inclusion and 0 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 8 Sep 2011. 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 Italy. 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?
efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients (time frame: sixteen months). 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 NCT01430208, which also lists 1 linked publication.
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 8 Sep 2011.