Conservative Endometrioma Surgery (BLAST)

BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrioma; Endometriosis Ovary
• Intervention / Treatment: Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla Tomassetti, MD, PhD; Phone Number: +3216340825; Email: carla.tomassetti@uzleuven.be
• Study Contact Backup: Name: Celine Bafort, MD; Phone Number: +3216340088; Email: celine.bafort@uzleuven.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2610
    • Recruiting
    • GZA Sint-Augustinus
    • Contact: Brecht Geysenbergh, MD
    • Principal Investigator: Brecht Geysenbergh, MD
  • Brussel, Belgium
    • Recruiting
    • Cliniques Universitaires Saint-Luc (UCL)
    • Contact: Laurence Beausaert
    • Principal Investigator: Jean-Luc Squifflet, MD, PhD
    • Sub-Investigator: Christine Wyns, MD, PhD
  • Leuven, Belgium, 3000
    • Recruiting
    • UZLeuven
    • Contact: Celine Bafort, MD; Email: celine.bafort@uzleuven.be
    • Principal Investigator: Carla Tomassetti, MD, PhD
    • Sub-Investigator: Celine Bafort, MD
  • Liège, Belgium, 4000
    • Recruiting
    • CHR La Citadelle
    • Contact: Marie Timmermans, Msc
    • Sub-Investigator: Linda Tebache, MD
    • Principal Investigator: Michelle Nisolle, MD, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Incomplete surgery for the pelvis
• Contra-indication for the use of contraception (combined or Progesteron only)
• Use of GnRH analogues preoperatively and in the first 3 months postoperatively
• (History of) hysterectomy
• Prior unilateral oophorectomy
• Pituitary/hypothalamic disorders
• Suspected malignancy
• Contralateral endometrioma of >2 cm
• AMH <0.7 preoperatively
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).; cf. different arms
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.	Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).; cf. different arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH levels 3 months postoperatively	To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).	3 months postoperatively

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain; GZA Ziekenhuizen Campus Sint-Augustinus; Centre Hospitalier Régional de la Citadelle
• Investigators: Principal Investigator: Carla Tomassetti, MD, PhD, Leuven University Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: S62899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No