Evaluate Both Technics on Procedure DurationNCT02406898
Evaluation of a Hysteroscopic Morcellator in Hysteroscopic Treatment of Submucosal Fibroids
A study testing morcellator uterine system (MH)Karl Storz, Tuttligen- Germany in people with Evaluate Both Technics on Procedure Duration and Characteristics and Perioperative Complications, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. Limit of this technic is duration of procedure which is correlated to operative complications. So, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Evaluate Both Technics on Procedure Duration, Characteristics and Perioperative Complications
- What is being tested?
- morcellator uterine system (MH)Karl Storz, Tuttligen- Germany
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Mar 2018
- 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
- Patient under effective contraception.
- Patient who underwent ultrasound confirming the presence of at least one or both uterine fibroids with a diameter less than 6 cm for the largest fibroid.
- Patient who underwent diagnostic hysteroscopy confirming the presence of one or two uterine fibroids classified as Type 0, 1 or 2 according to FIGO classification (10).
- Patient with an indication of intrauterine fibroid resection (bleeding disorders fetilité) by hysteroscopy.
- Patient who agreed to participate in the study and who signed informed consent.
Who cannot join
- Early Removal linked to patient's wish
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital de la conception
Marseille, 13354
Aubert Agostini, MD, 04.91.38.37.85, aubert.agostini@ap-hm.fr
About this study
Official title: Operative Hysteroscopy for Fibroma by Classic Resection Versus Morcellation: a Ramdomised Study
Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. Limit of this technic is duration of procedure which is correlated to operative complications. So, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. A new technic of hysteroscopic surgery is available which is quicker than conventional technic. This technic is poorly evaluated. Aim of this study is to evaluate both technics on procedure duration.
Read the detailed description
Material and Methods
We propose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring hysteroscopic surgery for fibroma. After informed consent, patients will be randomised in two groups: hysteroscopic surgery with morcellation technic and conventional hysteroscopy technic with resection. The main objective is duration of procedure. Secondary objectives are characteristics and perioperative complications (distension media quantity, cervical injury, uterine perforation), immediate et long term postoperative data's (postoperative pain and synechia). We hypothesis hysteroscopic with morcellation reduces duration of procedure of 50%. The estimated size of population number is 30 per group and 60 for the study.
Expected results
We expected a significant decrease of procedure duration with hysteroscopic morcellation. This data will be interesting according peroperative complications are correlated to procedure duration and allow hysteroscopic surgery to patients with large or several fibromas.
- Conditions
- Evaluate Both Technics on Procedure Duration, Characteristics and Perioperative Complications
- Being tested
- morcellator uterine system (MH)Karl Storz, Tuttligen- Germany
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morcellator uterine system (MH)Karl Storz, Tuttligen- GermanyDevice
| Study group | Role | What they receive |
|---|---|---|
| hysteroscopic surgery with morcellation technic | Experimental | The hysteroscope with the MH system will be introduced. Resection of fibroids or both will be realized. The procedure will end or when the fibroids will be completely resected.
the procedure may be suspended before complete resection of fibroids or uterine perforation or higher operating time to 90 minutes or amount of liquid used distension than 9 liters or distension fluid deficit of more than one liter . Receives: Device: morcellator uterine system (MH)Karl Storz, Tuttligen- Germany |
| conventional hysteroscopy technic with resection. | Active comparator | The hysteroscope with conventional resection system will be introduced. Resection of fibroids or both will be realized. The procedure will end or when the fibroids will be completely resected.
the procedure may be suspended before complete resection of fibroids or uterine perforation or higher operating time to 90 minutes or amount of liquid used distension than 9 liters or distension fluid deficit of more than one liter (4 ). Receives: Device: morcellator uterine system (MH)Karl Storz, Tuttligen- Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of procedure
The duration of the operative hysteroscopy is the period between the first introduction and the last out of the hysteroscope.
Measured: intraoperative
Secondary outcomes (5)
Distension fluid amount used during hysteroscopy
Measured: intraoperative
Cervical tear
Measured: intraoperative
The stopping rate of operative hysteroscopy before complete resection:
Measured: intraoperative
Postoperative pain upon awakening on a visual scale 0-10
Measured: 6 hours after end of procedure
The postoperative adhesions rate diagnosed by hysteroscopy control
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Both Technics on Procedure DurationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406898
- Sponsor's protocol ID
- 2014-43
- Status last verified
- May 2015
- First submitted
- 30 Mar 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Hysteroscopy for Fibroma by Classic Resection Versus Morcellation: a Ramdomised Study
- ClinicalTrials.gov ID
- NCT02406898
- Acronym / sponsor ID
- 2014-43
- Conditions
- Evaluate Both Technics on Procedure Duration, Characteristics and Perioperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 2 Apr 2015 (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.
Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. Limit of this technic is duration of procedure which is correlated to operative complications. So, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. A new technic of hysteroscopic surgery is available which is quicker than conventional technic. This technic is poorly evaluated. Aim of this study is to evaluate both technics on procedure duration.
Detailed description
Material and Methods
We propose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring hysteroscopic surgery for fibroma. After informed consent, patients will be randomised in two groups: hysteroscopic surgery with morcellation technic and conventional hysteroscopy technic with resection. The main objective is duration of procedure. Secondary objectives are characteristics and perioperative complications (distension media quantity, cervical injury, uterine perforation), immediate et long term postoperative data's (postoperative pain and synechia). We hypothesis hysteroscopic with morcellation reduces duration of procedure of 50%. The estimated size of population number is 30 per group and 60 for the study.
Expected results
We expected a significant decrease of procedure duration with hysteroscopic morcellation. This data will be interesting according peroperative complications are correlated to procedure duration and allow hysteroscopic surgery to patients with large or several fibromas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hysteroscopic surgery with morcellation technic | Experimental | Device: morcellator uterine system (MH)Karl Storz, Tuttligen- GermanyThe hysteroscope with the MH system will be introduced. Resection of fibroids or both will be realized. The procedure will end or when the fibroids will be completely resected. the procedure may be suspended before complete resection of fibroids or uterine perforation or higher operating time to 90 minutes or amount of liquid used distension than 9 liters or distension fluid deficit of more than one liter . |
| conventional hysteroscopy technic with resection. | Active comparator | Device: morcellator uterine system (MH)Karl Storz, Tuttligen- GermanyThe hysteroscope with conventional resection system will be introduced. Resection of fibroids or both will be realized. The procedure will end or when the fibroids will be completely resected. the procedure may be suspended before complete resection of fibroids or uterine perforation or higher operating time to 90 minutes or amount of liquid used distension than 9 liters or distension fluid deficit of more than one liter (4 ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient under effective contraception.
- Patient who underwent ultrasound confirming the presence of at least one or both uterine fibroids with a diameter less than 6 cm for the largest fibroid.
- Patient who underwent diagnostic hysteroscopy confirming the presence of one or two uterine fibroids classified as Type 0, 1 or 2 according to FIGO classification (10).
- Patient with an indication of intrauterine fibroid resection (bleeding disorders fetilité) by hysteroscopy.
- Patient who agreed to participate in the study and who signed informed consent.
Key exclusion criteria (1 listed)
- Early Removal linked to patient's wish
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 |
|---|---|---|
| morcellator uterine system (MH)Karl Storz, Tuttligen- Germany | Device | conventional hysteroscopy technic with resection., hysteroscopic surgery with morcellation technic |
Primary outcome
duration of procedure
Time frame: intraoperative
The duration of the operative hysteroscopy is the period between the first introduction and the last out of the hysteroscope.
5 secondary outcomes
Distension fluid amount used during hysteroscopy
Time frame: intraoperative
Cervical tear
Time frame: intraoperative
The stopping rate of operative hysteroscopy before complete resection:
Time frame: intraoperative
Postoperative pain upon awakening on a visual scale 0-10
Time frame: 6 hours after end of procedure
The postoperative adhesions rate diagnosed by hysteroscopy control
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing morcellator uterine system (MH)Karl Storz, Tuttligen- Germany in people with Evaluate Both Technics on Procedure Duration and Characteristics and Perioperative Complications, run by Assistance Publique Hopitaux De Marseille 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 5 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 29 Sep 2015. 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?
Contact Aubert AGOSTINI (04.91.38.37.85, aubert.agostini@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of procedure (time frame: intraoperative). 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 29 Sep 2015.