Impact of Incomplete Endometrial Ablation

Maxima Medical Center

Status: Active, not recruiting

Conditions: Heavy Menstrual Bleeding

Treatments: Device: hysteroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT06122363

Incomplete Novasure ablation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 estimated patients

Sex: Female

Ages: 34 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

121 participants in 2 patient groups

Complete Novasure endometrial ablation

Description:

After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation

Treatment:

Device: hysteroscopy

Incomplete Novasure endometrial ablation

Description:

After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation

Treatment:

Device: hysteroscopy