Endometrial tissue ablation: a clinical trial
ISRCTN | ISRCTN23845359 |
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DOI | https://doi.org/10.1186/ISRCTN23845359 |
Secondary identifying numbers | N/A |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 27/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Kleijn
Scientific
Scientific
Maxima Medisch Centrum
Locatie Veldhoven
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
Phone | +31 (0)40 8888000 |
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J.Kleijn@mmc.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Demonstrate that the HydroThermAblation procedure is equally effective compared to the Novasure procedure in achieving patent satisfaction at twelve months post-treatment for menorrhagia secondary to DUB. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Dysfunctional uterine bleeding |
Intervention | Hydrothermablator (HTA) System versus ablation with Novasure |
Intervention type | Other |
Primary outcome measure | Patients satisfaction: At each follow up visit/telephone call patients satisfaction was noted. Patients can express their level satisfaction by using - completely satisfied, satisfied, doubtful satisfied or not satisfied. It is also noted if any kind of reintervention is performed, such as the use of oral contraceptives or surgery. |
Secondary outcome measures | 1. Quality of life: all patients are asked to complete quality of life questionnaires at baseline, at two days, six weeks, three months, six months and twelve months after surgery. We evaluate quality of life with the medical outcomes study SF 36, the Rotterdam symptom checklist and a structured clinical history questionnaire. 2. Amennorhoea: at each follow up visit/ telephone call duration of menstruation, dysmennorhoea and presence of clots are registered. Patients also complete a pictorial chart. |
Overall study start date | 01/03/2005 |
Completion date | 01/08/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 160 |
Key inclusion criteria | 1. Refractory menorrhagia with no definable organic cause (dysfunctional uterine bleeding). 2. Age over 25 years old 3. Uterine sound measurement of 6.0 - 12 cm (external os to internal fundus). 4. Failed, contraindicated or intolerance to conservative (medical) therapy. 5. Menstrual Diary: A minimum PBLAC score of > 150 for 1 month. Intracavitary pathology, such as type 2 fibromas and small polyps (≤ 2cm), confirmed by hysteroscopy or Saline Infused Sonography (SIS) |
Key exclusion criteria | 1. Presence of bacteremia, sepsis, or other active systemic infection 2. Active or recurrent chronic pelvic inflammatory disease 3. Patients with documented coagulopathies 4. Symptomatic endometriosis 5. Prior uterine surgery (except low segment cesarean section) which interrupts the integrity of the uterine wall e.g.transmural myomectomy or classical cesarean section. Prior endometrial ablations. 6. Patients on medications that could thin the myometrial muscle, such as long-term steroid use. 7. Patients on anticoagulants. 8. Desire to have children or to preserve fertility 9. Patients currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation. 10. Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) or HSG. Specifically: Septate or bicornuate uterus or other congenital malformation of the uterine cavity. |
Date of first enrolment | 01/03/2005 |
Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maxima Medisch Centrum
Veldhoven
5500 MB
Netherlands
5500 MB
Netherlands
Sponsor information
Maxima Medisch Centrum (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Locatie Veldhoven Postbus 7777
Veldhoven
5500 MB
Netherlands
Phone | +31 (0)40 8888000 |
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info@mmc.nl | |
Website | http://www.mmc.nl/ |
https://ror.org/02x6rcb77 |
Funders
Funder type
Hospital/treatment centre
Máxima Medisch Centrum (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/10/2010 | Yes | No |