- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06219044
Evaluation of Ovarian Reserve and Recurrence Rate After DWLS Diode Laser OMA Vaporization (OMAlaser)
Ovarian Reserve, Recurrence Rate and Histopathologic Evaluation After DWLS Diode Laser Vaporization of Ovarian Endometriomas: Results From a Prospective, Multicentre, Clinical Trial.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cagliari
-
Monserrato, Cagliari, Italy, 09042
- University of Cagliari,Obstetrics and Gynecological Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 40 years old
- OMA mono or bilateral ≥ 3 and ≤ 8 cm in diameter
- presence of symptoms such as pelvic pain and sterility
Exclusion Criteria:
- Patients who are unable to provide written informed consent or to follow the procedures provided for by the protocol
- Age <18 years and> 40 years
- OMA mono or bilateral <3 and> 8 cm in diameter
- Asymptomatic patients
- Absence of histological confirmation of endometriosis cysts
- previous interventions on one or both annexes
- Failure to follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: symptomatic ovarian endometrioma
patients aged between 18 and 40 years with clinical and/or ultrasound diagnosis of symptomatic ovarian endometrioma
|
laser vaporization of ovarian endometrioma using a DWLS diode laser during a laparoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the ovarian reserve using AntiMullerian Hormone (AMH) assessment.
Time Frame: every 3 months for one year
|
Blood dosage of AntiMullerian Hormone expressed in nanograms/milliliter (ng/mL)
|
every 3 months for one year
|
Evaluation of the ovarian reserve using Antral follicular Count (AFC)
Time Frame: every 3 months for one year
|
counts of the number of antral follicles present in the ovary during ultrasound scan.
The count is presented in Numbers from 0 to any numbers (n°)
|
every 3 months for one year
|
Evaluation of the patients' symptoms
Time Frame: every 3 months for one year
|
assessed using the Visual Analogue Scale (VAS) , from 0 as the minimum to 10 as maximum value.
Higher scores mean a worse outcome
|
every 3 months for one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of endometrioma recurrence rate
Time Frame: every 3 months for one year
|
Ultrasound scan Evaluation of OMA recurrence.
Assessed using a percentage (%) of patients who present the endometrioma in the ovaries after surgery
|
every 3 months for one year
|
Evaluation of pregnancy rate
Time Frame: every 3 months for one year
|
Assessed as percentage (%) of patients who achieved pregnancy after surgery
|
every 3 months for one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E; ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698-704. doi: 10.1093/humrep/dei135. Epub 2005 Jun 24.
- Angioni S, Pontis A, Sorrentino F, Nappi L. Bilateral salpingo-oophorectomy and adhesiolysis with single port access laparoscopy and use of diode laser in a BRCA carrier. Eur J Gynaecol Oncol. 2015;36(4):479-81.
- Practice Committee of the American Society for Reproductive Medicine. Endometriosis and infertility: a committee opinion. Fertil Steril. 2012 Sep;98(3):591-8. doi: 10.1016/j.fertnstert.2012.05.031. Epub 2012 Jun 15.
- Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15.
- Benschop L, Farquhar C, van der Poel N, Heineman MJ. Interventions for women with endometrioma prior to assisted reproductive technology. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008571. doi: 10.1002/14651858.CD008571.pub2.
- Donnez J, Lousse JC, Jadoul P, Donnez O, Squifflet J. Laparoscopic management of endometriomas using a combined technique of excisional (cystectomy) and ablative surgery. Fertil Steril. 2010 Jun;94(1):28-32. doi: 10.1016/j.fertnstert.2009.02.065. Epub 2009 Apr 9.
- Tsolakidis D, Pados G, Vavilis D, Athanatos D, Tsalikis T, Giannakou A, Tarlatzis BC. The impact on ovarian reserve after laparoscopic ovarian cystectomy versus three-stage management in patients with endometriomas: a prospective randomized study. Fertil Steril. 2010 Jun;94(1):71-7. doi: 10.1016/j.fertnstert.2009.01.138. Epub 2009 Apr 25.
- Muzii L, Bellati F, Bianchi A, Palaia I, Manci N, Zullo MA, Angioli R, Panici PB. Laparoscopic stripping of endometriomas: a randomized trial on different surgical techniques. Part II: pathological results. Hum Reprod. 2005 Jul;20(7):1987-92. doi: 10.1093/humrep/deh851. Epub 2005 Apr 28.
- Guo SW. Recurrence of endometriosis and its control. Hum Reprod Update. 2009 Jul-Aug;15(4):441-61. doi: 10.1093/humupd/dmp007. Epub 2009 Mar 11.
- Ceccaroni M, Bounous VE, Clarizia R, Mautone D, Mabrouk M. Recurrent endometriosis: a battle against an unknown enemy. Eur J Contracept Reprod Health Care. 2019 Dec;24(6):464-474. doi: 10.1080/13625187.2019.1662391. Epub 2019 Sep 25.
- Seo JW, Lee DY, Yoon BK, Choi D. The age-related recurrence of endometrioma after conservative surgery. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:81-85. doi: 10.1016/j.ejogrb.2016.11.015. Epub 2016 Nov 16.
- Candiani M, Ottolina J, Posadzka E, Ferrari S, Castellano LM, Tandoi I, Pagliardini L, Nocun A, Jach R. Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2205-2211. doi: 10.1093/humrep/dey305.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMA Diode Laser Vaporization
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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