Robotic Surgical Management of Endometriosis: Excision Versus Ablation

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: Robotic ablation; Procedure: Robotic excision

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Robotic ablation; Half of the patients in the study will be randomized to robotic ablation of endometriosis with the argon beam coagulator (ABC).	Procedure: Robotic ablation; Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC)
Active Comparator: Robotic Excision; Half of the patients in the study will be randomized to robotic excision of endometriosis.	Procedure: Robotic excision; Robotic excision of endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Patients will document their pain on a VAS.	Baseline pre-operatively
Visual Analog Scale (VAS)	Patients will document their pain on a VAS.	6 months
Visual Analog Scale (VAS)	Patients will document their pain on a VAS.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life and Pain Questionnaires	Patients will complete quality of life and pain questionnaires to document their responses to treatment.	4 weeks,
Quality of Life and Pain Questionnaires	Patients will complete quality of life and pain questionnaires to document their responses to treatment.	6 months
Quality of Life and Pain Questionnaires	Patients will complete quality of life and pain questionnaires to document their responses to treatment.	12 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Kristin A Riley, MD, Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. Fertil Steril. 2004 Oct;82(4):878-84. doi: 10.1016/j.fertnstert.2004.03.046.
• Hart R, Hickey M, Maouris P, Buckett W, Garry R. Excisional surgery versus ablative surgery for ovarian endometriomata: a Cochrane Review. Hum Reprod. 2005 Nov;20(11):3000-7. doi: 10.1093/humrep/dei207.
• Daniell JF, McTavish G, Kurtz BR, Tallab F. Laparoscopic Use of Argon Beam Coagulator in the Management of Endometriosis. J Am Assoc Gynecol Laparosc. 1994 Aug;1(4, Part 2):S9. doi: 10.1016/s1074-3804(05)80894-1.
• Wright J, Lotfallah H, Jones K, Lovell D. A randomized trial of excision versus ablation for mild endometriosis. Fertil Steril. 2005 Jun;83(6):1830-6. doi: 10.1016/j.fertnstert.2004.11.066.
• Abbott JA, Hawe J, Clayton RD, Garry R. The effects and effectiveness of laparoscopic excision of endometriosis: a prospective study with 2-5 year follow-up. Hum Reprod. 2003 Sep;18(9):1922-7. doi: 10.1093/humrep/deg275.
• Falcone T, Lebovic DI. Clinical management of endometriosis. Obstet Gynecol. 2011 Sep;118(3):691-705. doi: 10.1097/AOG.0b013e31822adfd1.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Endometriosis; Robotics; Gynecology; Laparoscopy; Argon
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 43830