Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas
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- What is being studied
- The protocol lists: Argon Plasma Coagulation.
- Who it may be relevant to
- Registry conditions: Ovarian Endometrioma, Endometriosis. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas: A Prospective Pilot Study
Overview
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
- Procedure Argon 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.
Primary outcome measures
- Depth of thermal tissue effects in the ovarian endometrioma cyst wall [Time frame: Immediately after surgery (Day 0)]
Secondary outcome measures (6)
- Presence of residual endometriotic epithelium [Time frame: At surgery (Day 0)]
- Completeness of cyst lining ablation [Time frame: Immediately after surgery (Day 0)]
- Thermal damage to adjacent ovarian parenchyma [Time frame: At surgery (Day 0)]
- Technical success of argon beam application [Time frame: During surgery (Day 0)]
- Intraoperative complications [Time frame: During surgery (Day 0)]
- Postoperative complications [Time frame: Up to 30 days after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- University Hospital of Obstetrics and Gynecology, Inselspital Bern — Bern
Identifiers
NCT: NCT07711743 · ENDO-ARGON-01 · Protocol ID