Endometriosis, Ovarian Endometrioma
Conditions
Keywords
Argon Beam Coagulation, Ovarian Endometrioma, Endometriosis, Laparoscopy, Histopathology, Tissue Penetration, Ovarian Cystectomy, Fertility Preservation, Ovarian Reserve
Brief summary
The goal of this clinical trial is to evaluate the depth of tissue penetration of Argon Beam Coagulation (ABC) during laparoscopic surgery for ovarian endometriomas. Researchers want to determine how deeply ABC affects ovarian tissue and to generate data on the safety of this surgical technique. Participants will undergo standard laparoscopic surgery for ovarian endometriomas. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to the study protocol. The treated tissue will subsequently be excised as part of the planned surgery and analyzed histologically to measure the depth of tissue penetration.
Detailed description
Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age. Ovarian endometriomas are a common manifestation of the disease and frequently require surgical treatment. Conventional cystectomy may unintentionally remove healthy ovarian tissue, potentially reducing ovarian reserve and affecting future fertility. Tissue-preserving surgical techniques are therefore of increasing clinical interest. Argon Beam Coagulation (ABC) is an energy-based surgical technology that allows non-contact coagulation using ionized argon gas. Although ABC is increasingly used in endometriosis surgery, limited histological evidence is available regarding the depth of tissue penetration produced by this technique. This prospective, single-center interventional study will enroll women undergoing laparoscopic surgery for ovarian endometriomas at the University Hospital Bern. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to a standardized protocol. The treated tissue will subsequently be excised during the same operation and processed for histological examination. The primary objective of the study is to quantify the histological depth of tissue penetration of Argon Beam Coagulation in ovarian tissue. Secondary objectives include evaluating the consistency of tissue penetration and generating data that may support the safe use of ABC as a tissue-preserving surgical technique in the management of ovarian endometriomas.
Interventions
PROCEDUREArgon Plasma Coagulation
Standardized argon plasma coagulation (APC) is applied to the outer surface of the ovarian endometrioma capsule immediately before laparoscopic cystectomy. The resected tissue is subsequently processed for histological analysis to assess the depth of APC tissue penetration.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-40 years. * Indication for surgical treatment of ovarian endometrioma based on clinical symptoms and/or imaging findings. * Diagnosis of ovarian endometrioma ≥3 cm confirmed by preoperative imaging (ultrasound and/or MRI). * Planned laparoscopic cystectomy. * Written informed consent.
Exclusion criteria
* Expected lack of compliance or inability to understand the study procedures. * Previous surgical procedures on the affected ovary. * Recurrent ovarian endometrioma. * Pregnancy or breastfeeding. * Participation in another interventional clinical study that may influence study outcomes, such as anti-Müllerian hormone (AMH) levels or pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depth of thermal tissue effects in the ovarian endometrioma cyst wall | Immediately after surgery (Day 0) | Histological measurement of the maximum depth of tissue penetration induced by argon plasma coagulation in the ovarian endometrioma capsule after standardized pre-cystectomy application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of residual endometriotic epithelium | At surgery (Day 0) | Histological assessment of residual endometriotic epithelium after argon beam coagulation. |
| Completeness of cyst lining ablation | Immediately after surgery (Day 0) | Histological assessment of the completeness of ablation of the ovarian endometrioma cyst lining after argon beam coagulation. |
| Thermal damage to adjacent ovarian parenchyma | At surgery (Day 0) | Histological assessment of thermal damage extending into adjacent ovarian tissue. |
| Technical success of argon beam application | During surgery (Day 0) | Feasibility of standardized intraoperative argon beam coagulation, documented as successful completion of the planned procedure. |
| Intraoperative complications | During surgery (Day 0) | Occurrence of intraoperative complications related to the surgical procedure or study intervention. |
| Postoperative complications | Up to 30 days after surgery | Occurrence of postoperative complications following surgery. |
Countries
Switzerland
Contacts
CONTACTMichael David Mueller, Prof.
Outcome results
None listed