BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation. The 2 conservatives techniques used are: 1. The combined technique 2. CO2 laser vaporization only Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:
• Age: 18 - 40 years (both inclusive)
• Unilateral endometriotic cysts with a mean diameter of \>=2.5cm and ≤8 cm, measured in 3 dimensions.
• Presence of a contralateral endometrioma of ≤ 2cm is allowed
• Complaining of infertility and/or pain
• BMI ≤35
• Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery
Locations
Other Locations
Belgium
GZA Sint-Augustinus
RECRUITING
Antwerp
Cliniques universitaires Saint-LUC (UCL)
RECRUITING
Brussels
UZLeuven
RECRUITING
Leuven
CHR La Citadelle
RECRUITING
Liège
Contact Information
Primary
Carla Tomassetti, MD, PhD
carla.tomassetti@uzleuven.be
+3216340825
Backup
Celine Bafort, MD
celine.bafort@uzleuven.be
+3216340088
Time Frame
Start Date: 2019-10-24
Estimated Completion Date: 2026-12
Participants
Target number of participants: 92
Treatments
Active_comparator: The combined technique
First step consisting of stripping the cyst wall for 80% of the surface, followed by a second step consisting of ablation of the remaining 20% cyst surface.
Active_comparator: CO2 laser vaporization only
CO2 laser vaporization only of the complete inner cystic wall after drainage of the cyst content, irrigation and inspection of its inner wall. Ablation of the inner cyst wall using the CO2 laser (Lumenis). Power settings of 30-55W for CO2 laser beam and 6-10W for CO2 fibre are used. The laser should be on the ablate function to widen the beam (e.g. Surgitouch modus). The laser should be applied in Surgitouch modus so that it can ablate the cyst surface while preserving the underlying healthy tissue.
Related Therapeutic Areas
Sponsors
Collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, GZA Ziekenhuizen Campus Sint-Augustinus, Centre Hospitalier Régional de la Citadelle
Leads: Universitaire Ziekenhuizen KU Leuven