Robotic Surgical Management of Endometriosis: Excision Versus Ablation
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic ablation
Robotic excision
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Robotics, Laparoscopy, Endometriosis, Argon, Gynecology
Eligibility Criteria
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
Sites / Locations
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Robotic ablation
Robotic Excision
Arm Description
Half of the patients in the study will be randomized to robotic ablation of endometriosis with the argon beam coagulator (ABC).
Half of the patients in the study will be randomized to robotic excision of endometriosis.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
Patients will document their pain on a VAS.
Visual Analog Scale (VAS)
Patients will document their pain on a VAS.
Visual Analog Scale (VAS)
Patients will document their pain on a VAS.
Secondary Outcome Measures
Quality of Life and Pain Questionnaires
Patients will complete quality of life and pain questionnaires to document their responses to treatment.
Quality of Life and Pain Questionnaires
Patients will complete quality of life and pain questionnaires to document their responses to treatment.
Quality of Life and Pain Questionnaires
Patients will complete quality of life and pain questionnaires to document their responses to treatment.
Full Information
NCT ID
NCT02350790
First Posted
August 20, 2013
Last Updated
January 19, 2017
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02350790
Brief Title
Robotic Surgical Management of Endometriosis: Excision Versus Ablation
Official Title
Robotic Surgical Management of Endometriosis: Excision Versus Ablation With Argon Beam Coagulator (ABC)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Robotics, Laparoscopy, Endometriosis, Argon, Gynecology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic ablation
Arm Type
Active Comparator
Arm Description
Half of the patients in the study will be randomized to robotic ablation of endometriosis with the argon beam coagulator (ABC).
Arm Title
Robotic Excision
Arm Type
Active Comparator
Arm Description
Half of the patients in the study will be randomized to robotic excision of endometriosis.
Intervention Type
Procedure
Intervention Name(s)
Robotic ablation
Intervention Description
Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC)
Intervention Type
Procedure
Intervention Name(s)
Robotic excision
Intervention Description
Robotic excision of endometriosis
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Patients will document their pain on a VAS.
Time Frame
Baseline pre-operatively
Title
Visual Analog Scale (VAS)
Description
Patients will document their pain on a VAS.
Time Frame
6 months
Title
Visual Analog Scale (VAS)
Description
Patients will document their pain on a VAS.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of Life and Pain Questionnaires
Description
Patients will complete quality of life and pain questionnaires to document their responses to treatment.
Time Frame
4 weeks,
Title
Quality of Life and Pain Questionnaires
Description
Patients will complete quality of life and pain questionnaires to document their responses to treatment.
Time Frame
6 months
Title
Quality of Life and Pain Questionnaires
Description
Patients will complete quality of life and pain questionnaires to document their responses to treatment.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin A Riley, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16246860
Citation
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.
Results Reference
background
PubMed Identifier
9073672
Citation
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.
Results Reference
background
PubMed Identifier
15950657
Citation
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.
Results Reference
background
PubMed Identifier
15482763
Citation
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.
Results Reference
background
PubMed Identifier
12923150
Citation
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.
Results Reference
background
PubMed Identifier
21860303
Citation
Falcone T, Lebovic DI. Clinical management of endometriosis. Obstet Gynecol. 2011 Sep;118(3):691-705. doi: 10.1097/AOG.0b013e31822adfd1.
Results Reference
background
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Robotic Surgical Management of Endometriosis: Excision Versus Ablation
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