Rate of Complete Resection in a Unique Surgical TimeDIAPERNCT03402516
Comparison of Two Bipolar Resector in Less Than 3cm Myoma Resection
A study testing 18.5 resector and 26Fr resector in people with Rate of Complete Resection in a Unique Surgical Time, run by Bicetre Hospital at 1 site in France.
Trial summary
Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr resector with a potential benefit because of less dilatation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rate of Complete Resection in a Unique Surgical Time
- What is being tested?
- 18.5 resector and 26Fr resector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2017to 31 Mar 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years old
- With a type 0,1 or 2 unique myoma requiring surgery
Who cannot join
- No medical care
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Bicetre
Le Kremlin-Bicêtre, 94275
Perrine Capmas, MD-PhD, +33145217714, perrine.capmas@aphp.fr
About this study
Official title: Impact of the Diameter on the Performance of Two Bipolar Resectors 18.5Fr and 26Fr
Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr resector with a potential benefit because of less dilatation. These resectors are often used but no scientific evaluation has been performed.
Hypothesis of this non inferiority trial is that complete resection in a unique surgical time will be comparable with both resectors.
Read the detailed description
Myoma type 0, 1 or 2 are often symptomatic (abnormal uterine bleeding or infertility) and hysteroscopic resections are thus frequent. This management is a minimally invasive surgery.
Usually, a 26Fr resectoscope is used and the main articles on this topic report hysteroscopie resections with a 26Fr resectoscope. Miniaturization of resector led to decrease in the size of resectors with a potential benefit because of a less important cervical dilatation and then a smaller risk of adverse events and an increase in the number of surgery under local anaesthesia.
Use of 18.5Fr resectors is more and more frequent but, to our knowledge, it has never been evaluated for benefit on cervical dilatation but also for rate of complete resection in one time, surgical length and rate of unbalanced input/output.
Intuitively, a smaller diameter could led to a less traumatic cervical dilatation but it could also led to an higher risk of incomplete treatment in one time and a longer surgical duration and a more frequent unbalanced input/output.
No study compare use of these two resectors (18.5 and 26Fr) all the more randomized. With 26Fr resector, the rate of complete resection in one time for less than 3cm myoma is around 90%. If this rate is higher with the 18.5Fr resector, the risk/benefit balance (including economic evaluation) won't be favorable to this use.
- Being tested
- 18.5 resector, 26Fr resector
- Keywords
- hysteroscopic myomectomy, 26Fr resector, 18.5Fr resector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18.5 resectorDevice
hysteroscopic myomectomy with a 18.5 Fr resector after cervical dilatation until Hegar bougie number 7
26Fr resectorDevice
hysteroscopic myomectomy with a 26Fr resector after cervical dilatation until Hegar bougie number 10
| Study group | Role | What they receive |
|---|---|---|
| 18.5Fr resector | Experimental | Used of a 18.5Fr bipolar resector for hysteroscopic myomectomy. Cervical dilatation would be performed until Hegar bougie number 7 and then a classic hysteroscopic resection will be performed with a 18.5Fr bipolar resector. Receives: Device: 18.5 resector |
| 26Fr resector | Active comparator | Used of a 26Fr bipolar resector for hysteroscopic myomectomy. Cervical dilatation would be performed until Hegar bougie number 10 and then a classic hysteroscopic resection will be performed with a 24Fr bipolar resector. Receives: Device: 26Fr resector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison with chi square test of rate of complete surgery in one time
Complete resection of myoma in one time
Measured: 3 years
Secondary outcomes (5)
Duration of surgery
Comparison of duration of surgery between 2 arms
Measured: 3 years
Rate of unbalanced in and out balance
Comparison of rate of unbalanced in and out balance between the 2 groups. A in/out balance higher than 500cc will be consider has unbalanced).
Measured: 3 years
Cost effectiveness analyses
Comparison of cost for complete resection of myoma between groups
Measured: 3 years
Complications rate
Comparison of complications rate (including cervical complications)
Measured: 3 years
Use of a 26Fr resector
Report of the rate of use of a 26Fr resector in the 18.5Fr group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Nov 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rate of Complete Resection in a Unique Surgical TimeStudies 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
- Model description
- Randomized trial
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Capmas Perrine, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402516
- Sponsor's protocol ID
- 2016-A01740-51
- Acronym
- DIAPER
- Status last verified
- Jan 2021
- First submitted
- 26 Dec 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Diameter on the Performance of Two Bipolar Resectors 18.5Fr and 26Fr
- ClinicalTrials.gov ID
- NCT03402516
- Acronym / sponsor ID
- DIAPER / 2016-A01740-51
- Keywords
- hysteroscopic myomectomy, 26Fr resector, 18.5Fr resector
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 18 Jan 2018 (actual)
- 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.
Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr resector with a potential benefit because of less dilatation. These resectors are often used but no scientific evaluation has been performed.
Hypothesis of this non inferiority trial is that complete resection in a unique surgical time will be comparable with both resectors.
Detailed description
Myoma type 0, 1 or 2 are often symptomatic (abnormal uterine bleeding or infertility) and hysteroscopic resections are thus frequent. This management is a minimally invasive surgery.
Usually, a 26Fr resectoscope is used and the main articles on this topic report hysteroscopie resections with a 26Fr resectoscope. Miniaturization of resector led to decrease in the size of resectors with a potential benefit because of a less important cervical dilatation and then a smaller risk of adverse events and an increase in the number of surgery under local anaesthesia.
Use of 18.5Fr resectors is more and more frequent but, to our knowledge, it has never been evaluated for benefit on cervical dilatation but also for rate of complete resection in one time, surgical length and rate of unbalanced input/output.
Intuitively, a smaller diameter could led to a less traumatic cervical dilatation but it could also led to an higher risk of incomplete treatment in one time and a longer surgical duration and a more frequent unbalanced input/output.
No study compare use of these two resectors (18.5 and 26Fr) all the more randomized. With 26Fr resector, the rate of complete resection in one time for less than 3cm myoma is around 90%. If this rate is higher with the 18.5Fr resector, the risk/benefit balance (including economic evaluation) won't be favorable to this use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| 18.5Fr resector | Experimental | Device: 18.5 resectorUsed of a 18.5Fr bipolar resector for hysteroscopic myomectomy. Cervical dilatation would be performed until Hegar bougie number 7 and then a classic hysteroscopic resection will be performed with a 18.5Fr bipolar resector. |
| 26Fr resector | Active comparator | Device: 26Fr resectorUsed of a 26Fr bipolar resector for hysteroscopic myomectomy. Cervical dilatation would be performed until Hegar bougie number 10 and then a classic hysteroscopic resection will be performed with a 24Fr bipolar resector. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years old
- With a type 0,1 or 2 unique myoma requiring surgery
Key exclusion criteria (1 listed)
- No medical care
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 |
|---|---|---|
| 18.5 resectorhysteroscopic myomectomy with a 18.5 Fr resector after cervical dilatation until Hegar bougie number 7 | Device | 18.5Fr resector |
| 26Fr resectorhysteroscopic myomectomy with a 26Fr resector after cervical dilatation until Hegar bougie number 10 | Device | 26Fr resector |
Primary outcome
Comparison with chi square test of rate of complete surgery in one time
Time frame: 3 years
Complete resection of myoma in one time
5 secondary outcomes
Duration of surgery
Time frame: 3 years
Rate of unbalanced in and out balance
Time frame: 3 years
Cost effectiveness analyses
Time frame: 3 years
Complications rate
Time frame: 3 years
Use of a 26Fr resector
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18.5 resector and 26Fr resector in people with Rate of Complete Resection in a Unique Surgical Time, run by Bicetre Hospital at 1 site in France.
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 1 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 27 Jan 2021. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison with chi square test of rate of complete surgery in one time (time frame: 3 years). 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 27 Jan 2021.