Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Expected lack of compliance or inability to understand the study procedures.

Previous surgical procedures on the affected ovary.

Recurrent ovarian endometrioma.

Pregnancy or breastfeeding.

Trial design

Design model

Single group

Treatments tested in this trial

  • Argon Plasma Coagulation

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Argon Plasma Coagulation Before Ovarian Endometrioma CystectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Depth of thermal tissue effects in the ovarian endometrioma cyst wall

Histological measurement of the maximum depth of tissue penetration induced by argon plasma coagulation in the ovarian endometrioma capsule after standardized pre-cystectomy application.

Time frame
Immediately after surgery (Day 0)

Secondary outcomes

1

Presence of residual endometriotic epithelium

Histological assessment of residual endometriotic epithelium after argon beam coagulation.

Time frame
At surgery (Day 0)
2

Completeness of cyst lining ablation

Histological assessment of the completeness of ablation of the ovarian endometrioma cyst lining after argon beam coagulation.

Time frame
Immediately after surgery (Day 0)
3

Thermal damage to adjacent ovarian parenchyma

Histological assessment of thermal damage extending into adjacent ovarian tissue.

Time frame
At surgery (Day 0)
4

Technical success of argon beam application

Feasibility of standardized intraoperative argon beam coagulation, documented as successful completion of the planned procedure.

Time frame
During surgery (Day 0)

Other outcomes

Sponsors and contacts

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