Patients With an Indication for Myomectomy or PolymyomectomyPREVENDONCT04702399
Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy
A study testing GEL GROUP in people with Patients With an Indication for Myomectomy or Polymyomectomy, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients With an Indication for Myomectomy or Polymyomectomy
- What is being tested?
- GEL GROUP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 May 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
- Age ≥ 18
- Of childbearing age
- Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy
- FIGO 2 to 6 classification myomas
Who cannot join
- History of intra uterine synechia treatment
- Uterine malformation
- Patients under legal protection measure (guardianship or curatorship) or under security measure
- Pregnant or breastfeeding women
- Absence of health insurance; or patient with AME
- Absence of free, informed and written consent
Show all 9Show fewer
- Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy)
- Patient with upper genital infection
- Hypersensibility to hyaluronic acid
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy by the Abdominal Route: Prospective,Randomized, Multicenter and Pilot Study.
PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)
Read the detailed description
Myomas are a common pathology affecting a large population of women of reproductive age. Depending on their location and the patient's symptoms, surgical removal of fibroids may be indicated.
Interstitial or subserous myomas are accessible through the abdominal route (laparotomy or minimally invasive surgery).
The impact of this surgery on the endometrial cavity and the risk of post-surgery synechiae is poorly understood, although it is essential, especially in a population of women wishing to preserve their fertility. In order to reduce and prevent endometrial synechia formation, we suggest PREVENDO study which consist in the systematic intracavitary placement of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) immediately after surgery in patients undergoing abdominal myomectomy or polymyomectomy (laparotomy, laparoscopy, robot-assisted laparoscopy) and the evaluation of the proportion of endometrial synechiae 6 weeks after surgery in patients during diagnostic hysteroscopy performed 6 weeks after surgery.
- Being tested
- GEL GROUP
- Keywords
- Synechia, Myomas, Myomectomy, Polymyomectomy, Gynaecology
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEL GROUPDevice
Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
| Study group | Role | What they receive |
|---|---|---|
| GEL GROUP | Experimental | Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO) Receives: Device: GEL GROUP |
| CONTROL GROUP | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with endometrial synechiae
The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery.
Measured: 6 weeks after surgery (+/-2weeks)
Secondary outcomes (6)
Proportion of patients with moderate or severe endometrial synechiae
The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery.Severity is assessed using the American Fertility Society score (AFS)
Measured: 6 weeks after surgery (+/-2 weeks)
Proportion of patients with increased of menstrual bleeding or menstrual bleeding time
Assessed subjectively by patients (Increase vs No increase)
Measured: 6 weeks after surgery (+/- 2 weeks)
The quality of life
Assessed using EQ-5D-5L questionnary. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none, slight, moderate, severe or unable to perform. Levels are coded 1-5 and a total score is then generated.
Measured: 6 weeks after surgery (+/- 2 weeks)
Dysmenorrhea
Assessed using the visual analogic scale (VAS)
Measured: 6 weeks after surgery (+/- 2 weeks)
Spontaneous pelvic pain
Assessed using the visual analogic scale (VAS)
Measured: 6 weeks after surgery (+/- 2 weeks)
Metrorragia
Assessed subjectively by patients
Measured: 6 weeks after surgery (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With an Indication for Myomectomy or PolymyomectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffroy Doctor CANLORBE, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702399
- Sponsor's protocol ID
- APHP200247
- Acronym
- PREVENDO
- Status last verified
- Nov 2020
- First submitted
- 7 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy by the Abdominal Route: Prospective,Randomized, Multicenter and Pilot Study.
- ClinicalTrials.gov ID
- NCT04702399
- Acronym / sponsor ID
- PREVENDO / APHP200247
- Keywords
- Synechia, Myomas, Myomectomy, Polymyomectomy, Gynaecology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 8 Jan 2021 (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.
PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)
Detailed description
Myomas are a common pathology affecting a large population of women of reproductive age. Depending on their location and the patient's symptoms, surgical removal of fibroids may be indicated.
Interstitial or subserous myomas are accessible through the abdominal route (laparotomy or minimally invasive surgery).
The impact of this surgery on the endometrial cavity and the risk of post-surgery synechiae is poorly understood, although it is essential, especially in a population of women wishing to preserve their fertility. In order to reduce and prevent endometrial synechia formation, we suggest PREVENDO study which consist in the systematic intracavitary placement of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) immediately after surgery in patients undergoing abdominal myomectomy or polymyomectomy (laparotomy, laparoscopy, robot-assisted laparoscopy) and the evaluation of the proportion of endometrial synechiae 6 weeks after surgery in patients during diagnostic hysteroscopy performed 6 weeks after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEL GROUP | Experimental | Device: GEL GROUPIntracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO) |
| CONTROL GROUP | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Of childbearing age
- Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy
- FIGO 2 to 6 classification myomas
Key exclusion criteria (9 listed)
- History of intra uterine synechia treatment
- Uterine malformation
- Patients under legal protection measure (guardianship or curatorship) or under security measure
- Pregnant or breastfeeding women
- Absence of health insurance; or patient with AME
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 |
|---|---|---|
| GEL GROUPApplication of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity | Device | GEL GROUP |
Primary outcome
The proportion of patients with endometrial synechiae
Time frame: 6 weeks after surgery (+/-2weeks)
The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery.
6 secondary outcomes
Proportion of patients with moderate or severe endometrial synechiae
Time frame: 6 weeks after surgery (+/-2 weeks)
Proportion of patients with increased of menstrual bleeding or menstrual bleeding time
Time frame: 6 weeks after surgery (+/- 2 weeks)
The quality of life
Time frame: 6 weeks after surgery (+/- 2 weeks)
Dysmenorrhea
Time frame: 6 weeks after surgery (+/- 2 weeks)
Spontaneous pelvic pain
Time frame: 6 weeks after surgery (+/- 2 weeks)
Metrorragia
Time frame: 6 weeks after surgery (+/- 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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.
Geoffroy Doctor CANLORBE study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing GEL GROUP in people with Patients With an Indication for Myomectomy or Polymyomectomy, run by Assistance Publique - Hôpitaux de Paris.
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 4 inclusion and 9 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 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Geoffroy Doctor CANLORBE (01 42 17 81 11, geoffroy.canlorbe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with endometrial synechiae (time frame: 6 weeks after surgery (+/-2weeks)). 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 8 Jan 2021.