Conservative Endometrioma Surgery (BLAST)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Endometriosis Ovary; Endometrioma

Treatments: Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

Study type: Interventional

Funder types: Other

Identifiers

NCT04151433

S62899

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

The combined technique

Active Comparator group

Description:

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.

Treatment:

Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

CO2 laser vaporization only

Active Comparator group

Description:

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.

Treatment:

Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).