Clinical trial NCT06122363: Impact of Incomplete Endometrial Ablation
Official title: The Impact of Incomplete Endometrial Ablation on the Success Rate of Novasure Endometrial Ablation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heavy Menstrual Bleeding
Lead sponsor: Maxima Medical Center
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 121
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study was carried out using the data of women who participated in the MIRA study and the MIRA2 study including RCT and prospective cohort database. These women have given informed consent for their data to be used for future research into treatments for heavy menstrual bleeding. To be eligible for study inclusion, women had to suffer from heavy menstrual bleeding, and have undergone Novasure endometrial ablation at Máxima MC between January 2012 and July 2023. Women were excluded from the database if the hysteroscopy images were not saved, or these images were of poor quality.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Endometrial ablation between 2012 and 2023 in Máxima Medical Centre
* Women had to suffer from heavy menstrual bleeding

Exclusion Criteria:

- No saved hysteroscopy images or bad quality hysteroscopy images

Primary outcomes:
measure: Pictorial Blood Assessment Chart (PBAC) score
timeFrame: 24 months
Secondary outcomes:
measure: Rate of reintervention
timeFrame: 24 months
measure: Dysmennorrhea
timeFrame: 24 months
measure: Number of patients having controlled bleeding
timeFrame: 24 months
measure: Satisfaction of the patient with the treatment
timeFrame: 24 months
Other outcomes:
measure: Number of possible prognostic variables predicting the occurrence of incomplete endometrial ablation.
timeFrame: baseline
Locations:
city: Veldhoven
country: Netherlands
facility: Máxima MC
state: Noord-Brabant
Study officials:
affiliation: Maxima Medical Center
name: Marlies M.Y. Bongers, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: