Evaluation of Ovarian Reserve and Recurrence Rate After DWLS Diode Laser OMA Vaporization
Condition: Endometrioma; Ovarian Endometriosis; Ovarian Endometrioma
MeSH terms: Endometriosis; Recurrence
Study type: Interventional

Summary: 
      PURPOSE OF THE STUDY The study aims to evaluate the effectiveness of the Dual Wavelength
      Laser System (DWLS) diode laser on the treatment of endometrioma (OMA), with ablation and
      vaporization of the cystic capsule without performing the stripping technique, in terms of
      ovarian reserve and recurrence rate.
    

Detailed description: 
      BACKGROUND Endometriosis cyst, or endometrioma (OMA), is one of the most frequent
      gynaecological pathologies and is commonly associated with symptoms such as infertility and
      chronic pelvic pain. Randomized and meta-analysis studies demonstrate how the most effective
      surgery, in terms of percentages of pregnancy after surgery and minor rates of recurrence of
      cysts or pelvic pain, is the complete removal of the cyst wall through laparoscopic
      "stripping". However, data has recently emerged on the possible damage determined by
      "stripping" surgery on the healthy ovarian tissue adjacent to the OMA.

      Studies on the anatomopathological characteristics of the wall of the OMA surgically removed
      have shown that, with the complete removal surgery, part of ovarian tissue is inadvertently
      removed together with the OMA wall in almost all cases since there is no real cleavage plan
      between cysts and healthy ovarian tissue. The post-surgery ovarian reserve has been reported,
      measured as lower levels of antimullerian hormone (AMH), minor values of antral follicular
      count (AFC), and reduced postoperative ovarian volumes. Worst performances have also been
      reported for the induction of ovulation for in vitro fertilization techniques. In the event
      of the removal of bilateral OMA, 2-4% of early premature ovarian failure has been reported,
      confirming possible surgical damage to healthy ovarian tissue. Following these data, the
      international scientific community has begun to question the effective superiority of the
      complete removal approach of the cystic wall, or "stripping", given these new acquisitions on
      post-surgical ovarian damage. Therefore, the theme of the best therapeutic approach to OMA
      has become one of the most debated in the gynaecological field. Despite the data on the
      possible surgical damage, surgical intervention remains one of the cornerstones of OMA
      therapy.

      The recurrence rate evaluation is one of the primary endpoints of all OMA surgery studies.
      Guo S.w. has estimated a recurrence rate of 21.5% to 2 years and 40-50% to 5 years. In a
      recent systematic review of Ceccaroni M. et al., 12-30% recurrence rates are shown 2-5 years
      after surgical treatment.

      An alternative technique to "stripping" is the fenestration of the cyst followed by ablation
      or vaporization with the laser of the internal wall of the cyst left "in situ" without the
      complete removal of the cystic wall with healthy ovarian tissue. Candiani et al.
      demonstrated, in their randomized study, that the "One Step" vaporization of the OMA capsule
      with the CO2 laser is more effective than stripping in reducing the residual follicular
      damage (in terms of AMH and AFC).

      For better results regarding controlled ablation of the cystic wall of the OMA, the DWLS
      diode laser could be helpful. The combination of two wavelengths, 980 Nm and 1470 Nm, gives a
      contemporary absorption in H2O and haemoglobin with an excellent ability of hemostasis, cut
      and vaporization, as previously demonstrated in laparoscopic and hysteroscopic surgery.

      PURPOSE OF THE STUDY The study aims to evaluate the effectiveness of the DWLS diode laser on
      the treatment of OMA, with ablation and vaporization of the cystic capsule without performing
      the stripping technique, in terms of ovarian reserve, recurrence rate and patient's symptoms.

      Primary objective Evaluation of the ovarian reserve regarding AFC, AMH and the patient's
      symptoms.

      Secondary objective Evaluation of OMA recurrence rates on the treated ovary and pregnancy
      rate of the patients operated on.

      EXPECTED BENEFITS Compared to the stripping technique with complete removal of the cystic
      wall, this approach could make the treatment easier and faster but, above all, less harmful
      for the healthy ovarian parenchyma below the cyst.

      Compared to the one-step technique with CO2 laser, the combination of the two wavelengths of
      diode lasers would allow a more controlled ablation of the endometriosis tissue for its
      well-known characteristics of hemostasis and vaporization even in the most bloody tissues e
      irrigated by physiological solution.

      INTERVENTION STRATEGY AND INSTRUMENTS The investigators plan to recruit 70 patients of
      reproductive age with mono of bilateral OMA with a diameter ≥ 3 and ≤ 8 cm associated with
      infertility or pelvic pain who have never carried out previous interventions on one or both
      annexes. The cyst diameter cut-offs were chosen according to the previous data present in the
      literature and guidelines for the management of OMA. The patients will be evaluated at the
      endometriosis/chronic pelvic pain centre of the gynaecology unit of the University Hospital
      of Monserrato (Cagliari) and in the other centres involved in the study. All patients will
      perform a visit, a transvaginal ultrasound and where magnetic resonance imaging of the pelvis
      is necessary to provide accurate information on the location of the endometriosis pathology
      and to exclude other coexisting uterine or annexial diseases.

      All surgical procedures will be performed in operating laparoscopy under general anaesthesia.

      In all patients, the diagnosis of OMA will be confirmed by surgical exploration and
      histopathological examination.

      During the surgery, the DWLS diose laser will be used to vaporise the endometrioma capsule
      after opening, aspiration of the liquid and subversion of the internal wall of the cyst.
      Before using the laser, an accurate exploration of the cyst capsule and a biopsy on it will
      be performed. The removed samples will be sent for histological examination by requiring the
      measurement of the thickness of the endometriosis capsule. After surgery, all patients will
      be followed over time at quarterly intervals in the first year. At each follow-up visit, the
      presence of pain symptoms will be checked (dysmenorrhea, dyspareunia, chronic pelvic pain,
      dyschezia, dysuria) in patients operated for pelvic pain and the presence of pregnancy in
      patients operated by infertility to evaluate the cure or recurrence rates of the symptoms.

      Transvaginal ultrasounds will be performed on each control for the evaluation of the presence
      or absence of a recurrence of OMA. The cyst must have a diameter of at least 2 cm to satisfy
      the ultrasound criteria for the recurrence of OMA, and it must persist over time (for at
      least two consecutive menstrual cycles) to be distinguished as a functional cyst.

      The AFC will also be assessed During the ultrasound examination between the second and
      seventh day of the cycle. The AMH will systematically be evaluated for the measurement of the
      ovarian reserve.

      During the first visit, it will be detected:

        -  Clinical and surgical history

        -  Full target examination

        -  Gynecological examination

        -  Concomitant drugs and their indication

        -  Pelvic and trans-vaginal ultrasounds were performed between the second and seventh day
           of the cycle with an evaluation of the parameters of ovarian functionality, OMA volumes,
           and the ovary and AFC on both ovaries.

        -  Dosage of the AMH hormone

      Follow up evaluation

      With quarterly frequency in the first year:

        -  Clinical evaluation

        -  Pelvic and trans-vaginal ultrasounds were performed between the second and seventh day
           of the cycle to evaluate the parameters of ovarian functionality and AFC on both ovaries
           and possible recurrence of the OMA.

        -  Dosage of the AMH hormone.

      POPULATION Seventy patients aged between 18 and 40 with clinical and ultrasound diagnoses of
      mono or bilateral OMA cysts. To be suitable for inclusion, patients with an ultrasound
      diagnosis of mono or bilateral OMA should present symptoms such as pelvic pain or sterility.

      STATISTICAL ANALYSIS The data will be tabulated on a specific database and analyzed using
      specific software. A descriptive output will be created, and the comparison between variables
      will be made through parametric and non-parametric tests with a level of significance of 95%.
      The IBM SPSS Statistics software will be used for statistical analysis.
    

Intervention name(s): laparoscopic endometrioma laser vaporization
Intervention type(s): Procedure
Intervention description(s): laser vaporization of ovarian endometrioma using a DWLS diode laser during a laparoscopy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometrioma; laparoscopy; diode laser