Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Protocol ID | Other Identifier | ENDO-ARGON-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argon Plasma Coagulation Before Ovarian Endometrioma Cystectomy | Experimental | Participants undergo standardized argon plasma coagulation (APC) on the surface of the ovarian endometrioma capsule immediately before laparoscopic cystectomy. The resected capsule is subsequently analyzed histologically to determine the depth of APC tissue penetration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argon Plasma Coagulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after surgery (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of residual endometriotic epithelium | Histological assessment of residual endometriotic epithelium after argon beam coagulation. | At surgery (Day 0) |
| Completeness of cyst lining ablation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael David Mueller, Prof. | Contact | +41 31 63 2 12 01 | Michel.Mueller@insel.ch |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Obstetrics and Gynecology, Inselspital Bern | Recruiting | Bern | Canton of Bern | 3008 | Switzerland |
Data sharing plans have not yet been determined.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D057908 | Argon Plasma Coagulation |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D002425 | Cautery |
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Histological assessment of the completeness of ablation of the ovarian endometrioma cyst lining after argon beam coagulation.
| Immediately after surgery (Day 0) |
| Thermal damage to adjacent ovarian parenchyma | Histological assessment of thermal damage extending into adjacent ovarian tissue. | At surgery (Day 0) |
| Technical success of argon beam application | Feasibility of standardized intraoperative argon beam coagulation, documented as successful completion of the planned procedure. | During surgery (Day 0) |
| Intraoperative complications | Occurrence of intraoperative complications related to the surgical procedure or study intervention. | During surgery (Day 0) |
| Postoperative complications | Occurrence of postoperative complications following surgery. | Up to 30 days after surgery |
| D000091662 | Genital Diseases |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |