Impact of Incomplete Endometrial Ablation
Study Details
Study Description
Brief Summary
The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The primary outcome is blood loss at 24 months after treatment, measured with the PBAC-score according to Higham. To calculate this score women were asked, in the MIRA and MIRA2 study, to record their menstrual blood loss for one month counting the number of super tampons or pads used each day. The total score was calculated using a score of 1 for each lightly saturated tampons. For pads the scores were respectively 1, 5 and 20. Secondary outcome measures were controlled bleeding, defined as a PBAC-score not exceeding 75 points, PBAC score of zero, re-intervention rate 24 months after treatment, satisfaction with treatment (measured with a 5-point Likert scale) and dysmenorrhea.
In addition, multiple variables were analyzed in predicting the occurrence of incomplete endometrial ablation, including age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization. Information was collected from EPD and the MIRA and MIRA2 databases.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Complete Novasure endometrial ablation After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation |
Device: hysteroscopy
uterine hysteroscopy right after Novasure endometrial ablation
|
| Incomplete Novasure endometrial ablation After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation |
Device: hysteroscopy
uterine hysteroscopy right after Novasure endometrial ablation
|
Outcome Measures
Primary Outcome Measures
- PBAC score [24 months]
blood loss measurement
Secondary Outcome Measures
- reintervention [24 months]
chirurgical and Medical reintervention
- dysmennorrhea [24 months]
presence of dysmennorrhea
- controlled bleeding [24 months]
PBAC score < 75
- satisfaction of the patient with the treatment [24 months]
satisfaction measured with a 5-point Likert scale
Other Outcome Measures
- Possible prognostic variables predicting the occurrence of incomplete endometrial ablation [baseline]
Age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Endometrial ablation between 2012 and 2021 in Máxima Medical Centre
-
Women had to suffer from heavy menstrual bleeding
Exclusion Criteria:
- No saved hysteroscopy images or bad quality hysteroscopy images
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Máxima MC | Veldhoven | Noord-Brabant | Netherlands | 5500MB |
Sponsors and Collaborators
- Maxima Medical Center
Investigators
- Principal Investigator: Marlies M.Y. Bongers, PhD, MD, Maxima Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Incomplete Novasure ablation