Robotic Surgical Management of Endometriosis: Excision Versus Ablation

Penn State Health

Status: Completed

Conditions: Endometriosis

Treatments: Procedure: Robotic excision; Procedure: Robotic ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02350790

43830

Details and patient eligibility

About

Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned to either ablation or excision of endometriosis. The investigators think that patients who have excision of endometriosis will have greater relief of pain.

Full description

Patients with known endometriosis based on prior surgical pathology or suspected endometriosis based on symptomatology who plan on undergoing diagnostic laparoscopy will be offered enrollment in the study. They will complete preoperative pain assessments with the tools outlined above. At the time of diagnostic laparoscopy, patients found to have endometriosis will be staged according to the American Society of Reproductive Medicine guidelines. Patients with Stage 4 or deeply infiltrating endometriosis will be excluded from the study. At that point, the patients will be randomized in the operating room to either laparoscopic excision of endometriosis or laparoscopic ablation with the argon beam coagulator. Patients will be stratified according to the presence or absence of the Levonorgestrel-Intrauterine Device.

Pain assessments will be performed immediately postoperatively in the recovery area. Pain assessments will again be performed at 4 weeks, 6 months and 12 months. We will use the VAS pain scale and validated questionnaires.

Enrollment: 73 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Endometriosis
• Chronic Pelvic Pain
• Stage 1-3 Endometriosis
• Reproductive aged women

Exclusion criteria

• Stage 4 Endometriosis
• Deeply Infiltrating Endometriosis
• Patients who decline surgical management of endometriosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Robotic ablation

Active Comparator group

Description:

Half of the patients in the study will be randomized to robotic ablation of endometriosis with the argon beam coagulator (ABC).

Treatment:

Procedure: Robotic ablation

Robotic Excision

Active Comparator group

Description:

Half of the patients in the study will be randomized to robotic excision of endometriosis.

Treatment:

Procedure: Robotic excision