Impact of Incomplete Endometrial Ablation

• Conditions: Heavy Menstrual Bleeding
• Interventions: Device: hysteroscopy

• Registration Number: NCT06122363
• Lead Sponsor: Maxima Medical Center

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.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-09-30
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-05
• Study First Posted: 2023-11-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complete Novasure endometrial ablation	hysteroscopy	After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation
Incomplete Novasure endometrial ablation	hysteroscopy	After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation

Primary Outcome Measures

Name	Time	Method
Pictorial Blood Assessment Chart (PBAC) score	24 months	Blood loss of 1 month, measured by the number of needed tampons/pads and how heavily they are filled with blood. The higher the score, the more severe blood loss. From 150 points the amount is defined as heavy menstrual bleeding.

Secondary Outcome Measures

Name	Time	Method
Satisfaction of the patient with the treatment	24 months	Satisfaction measured with a 5-point Likert scale. 1=very unsatisfied, 2= unsatisfied, 3= neutraal, 4= satisfied, 5= very satisfied.
Rate of reintervention	24 months	Surgical and Medical reintervention
Number of patients having controlled bleeding	24 months	Pictorial Blood Assessment Chart (PBAC) score less than 75.
Dysmennorrhea	24 months	Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe.

Trial Locations

Locations (1)

Máxima MC; 🇳🇱 Veldhoven, Noord-Brabant, Netherlands