RecruitingNot ApplicableNCT04151433

Conservative Endometrioma Surgery

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

92 participants

Start Date

Oct 24, 2019

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria7

  • Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.
  • 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 Criteria10

  • 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

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Interventions

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

cf. different arms


Locations(4)

GZA Sint-Augustinus

Antwerp, Belgium

Cliniques universitaires Saint-LUC (UCL)

Brussels, Belgium

UZLeuven

Leuven, Belgium

CHR La Citadelle

Liège, Belgium

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NCT04151433


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