|- candidate number||1161|
|- NTR Number||NTR98|
|- Date ISRCTN created||12-sep-2005|
|- date ISRCTN requested||18-aug-2005|
|- Date Registered NTR||29-jul-2005|
|- Secondary IDs||N/A |
|- Public Title||Endometrial tissue ablation: a clinical trial.|
|- Scientific Title||Endometrial tissue ablation: a clinical trial.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Dysfunctional uterine bleeding|
|- Inclusion criteria||1. Refractory menorrhagia with no definable organic cause (dysfunctional uterine bleeding);|
2. Ages over 25 years old;
3. Uterine sound measurement of 6.0 ¨C 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;
6. Intracavitary pathology, such as type 2 fibromas and small polyps (¡Ü 2cm), confirmed by hysteroscopy or Saline Infused Sonography (SIS).
|- 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;
6. Prior endometrial ablations;
7. Patients on medications that could thin the myometrial muscle, such as long-term steroid use;
8. Patients on anticoagulants;
9. Desire to have children or to preserve fertility;
10. Patients currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation;
11. Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) or HSG. Specifically:
11.1 Septate or bicornuate uterus or other congenital malformation of the uterine cavity.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2005|
|- planned closingdate||1-aug-2007|
|- Target number of participants||160|
|- Interventions||Hydrothermablator (HTA) system versus ablation with novasure.|
|- Primary outcome||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¡¯s also noted if any kind of reintervention is performed, such as the use of oral contraceptives or surgery.
|- Secondary outcome||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;
At each follow up visit/ telephone call duration of menstruation, dysmennorhoea and presence of clots are registered. Patients also complete a pictorial chart.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. J. Kleijn|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Marlies Bongers|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Máxima Medical Center|
|- Brief summary||Objective:|
To compare patient satisfaction amd health-related quality of life (HRQoL) after bipolar radio frequency ablation and ablation with a HYDROTHERMABLATOR (HTA) SYSTEM in women with dysfunctional uterine bleeding.
Randomized clinical trial.
Women suffering from dysfunctional uterine bleeding.
Bipolar radio frequency ablation and ablation with aHYDROTHERMABLATOR (HTA) SYSTEM .
Main outcome measure(s):
Patients will be asked to report treatment satisfaction complete HRQoL questionnaires at baseline, and at 3 months, 6 months, and 12 months after surgery. The questionnaires contain the medical outcomes study Short-Form 36 (SF-36) and a structured clinical history questionnaire.
|- Main changes (audit trail)|
|- RECORD||29-jul-2005 - 9-dec-2009|