NCT02350790

Robotic Surgical Management of Endometriosis: Excision Versus Ablation

Robotic Surgical Management of Endometriosis: Excision Versus Ablation With Argon Beam Coagulator (ABC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
PROCEDURE	Robotic ablation	Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC)
PROCEDURE	Robotic excision	Robotic excision of endometriosis

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-01-30
• Last updated: 2017-01-23

Locations

1 site across 1 country: United States