Conservative Endometrioma Surgery

Study Overview
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Brief Summary
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To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation. The 2 conservatives techniques used are: The combined technique CO2 laser vaporization only Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.

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

Conditions
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Endometriosis Ovary, Endometrioma

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The combined technique<br>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).<br>* cf. different arms<br>|
| Active Comparator: CO2 laser vaporization only<br>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).<br>* cf. different arms<br>|

What is the study measuring?
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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 |