Endometrial tissue ablation: a clinical trial

ISRCTN	ISRCTN23845359
DOI	https://doi.org/10.1186/ISRCTN23845359
Protocol serial number	N/A
Sponsor	Maxima Medisch Centrum (The Netherlands)
Funder	Máxima Medisch Centrum (Netherlands)

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

Maxima Medisch Centrum
Locatie Veldhoven
P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Phone	+31 (0)40 8888000
Email	J.Kleijn@mmc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No