Ovarian Endometrioma Clinical Trial
Official title:
Evaluating Ovarian Reserve After Conventional Laparoscopy Versus Robotic Surgery for Bilateral Endometrioma: a Randomized Controlled Trial.
The aim of this study is to perform a randomized study investigating AMH recovery comparing robot-assisted laparoscopy and conventional laparoscopy in patients with bilateral ovarian endometrioma. It is hypothesized that in patients with endometriomas, a robot-assisted approach may provide improved instrument navigation resulting in more precise dissection and therefore removal of less healthy ovarian tissue compared to conventional laparoscopy. AMH is the most widely used parameter for predicting functional ovarian reserve. Postoperative AMH levels were associated with the number of follicles in specimens due to the removal of ovarian cortex during surgery . Furthermore, the reduction in AMH level after surgery is higher in bilateral endometrioma. The investigators hypothesize, on the basis of Lee at al., 2020, that patients with bilateral endometrioma will have significantly higher AMH levels 6 months after robot-assisted laparoscopy than patients who were treated with conventional laparoscopy. Therefore, the primary outcome is postoperative serum AMH level recovery in patients undergoing conventional laparoscopy versus robot-assisted laparoscopy. Aims: The aim of this study is to investigate postoperative differences in ovarian reserve differing between robot-assisted laparoscopy compared to conventional laparoscopy in patients with bilaterial ovarian endometrioma by comparing serum AMH (sAMH) level recovery. Study population: The study population will consist of women aged between 18 and 45 years who are referred to our gynecologic outpatient clinic due to bilateral endometrioma. Women with an indication for surgery can be included in this trial. Methods: Laparoscopic-assisted resection of endometriosis will be performed using up to four 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. Superficial and deep endometriosis resection will be performed in the usual standard fashion. Histological confirmation of endometriosis will be performed. The primary outcome is postoperative serum AMH (sAMH) level recovery. This will be evaluated 6 months after surgery.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Bilateral endometrioma - Surgical endometriosis resection is planned - sAMH > 1.0 ng/ml Exclusion Criteria: - History of malignant diseases - History of adnexal surgery - Subject is unable or unwilling to participate - Postmenopausal women |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum AMH (sAMH) from baseline to 6 months after the operation | postoperative sAMH (6 months after the operation) compared to preoperative sAMH | 6 months after the operation | |
Secondary | Change in antral follicle count (AFC) from baseline to 6 months after the operation | antral follicle count (AFC) measured via transvaginal sonography | 6 months after the operation | |
Secondary | change in ovarian volume from baseline to 6 months after the operation | ovarian volume measured via transvaginal sonography (preoperative ovarian volume - endometrioma volume versus postoperative ovarian volume) | 6 months after the operation | |
Secondary | change in follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from baseline to 6 months after the operation | postoperative FSH and LH(6 months after the operation) compared to preoperative FSH and LH (both times measured within the first 2-5 days of menstrual cycle) | 6 months after the operation | |
Secondary | rate of intraoperative adverse events | rate of intraoperative adverse events (bladder injury, bowel injury, ureteral obstruction, massive bleeding) | 1 day | |
Secondary | rate of postoperative adverse events | rate of postoperative adverse events related to surgery (classified using Clavien Dindo classification) | 4 weeks | |
Secondary | operation time | operation time in minutes | 1 day | |
Secondary | length of hospitalization (following the operation) | length of hospitalization in days | 2 weeks | |
Secondary | blood loss | change of hemoglobin levels 24 hours after surgery | 1 day | |
Secondary | laparotomic conversion rate | laparotomic conversion rate | 1 day | |
Secondary | follicle number in the histologic tissue sections | follicle number in the histologic tissue sections | 1 day | |
Secondary | change of the Endometriosis Health Profile (EHP) EHP-30 from baseline to 6 months after the operation | questionnaires: the Endometriosis Health Profile (EHP) EHP-30 (preoperative versus 6 months after the operation | 6 months after the operation | |
Secondary | 10-point Likert scale for cosmetic satisfaction | questionnaires: 10-point Likert scale for cosmetic satisfaction | 6 months after the operation | |
Secondary | Disease recurrence rate up to 12 months after surgery | Endometriosis recurrence can have different levels: symptoms recurrence based on patient history (VAS pain score = 5), but no proof of recurrence by imaging and/or surgery; endometriosis recurrence based on non-invasive imaging in patients with or without symptoms; recurrence of histologically proven endometriosis: when the patient is re-operated, endometriosis is visually observed and confirmed histologically. | 12 months after the operation |
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