Robotic Surgical Management of Endometriosis: Excision Versus Ablation

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Procedure: Robotic excision; Procedure: Robotic ablation

• Registration Number: NCT02350790
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2013-08-20
• Study Start: 2013-12
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Excision	Robotic excision	Half of the patients in the study will be randomized to robotic excision of endometriosis.
Robotic ablation	Robotic ablation	Half of the patients in the study will be randomized to robotic ablation of endometriosis with the argon beam coagulator (ABC).

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	12 months	Patients will document their pain on a VAS.

Secondary Outcome Measures

Name	Time	Method
Quality of Life and Pain Questionnaires	12 months	Patients will complete quality of life and pain questionnaires to document their responses to treatment.

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States