Robotic Surgical Management of Endometriosis: Excision Versus Ablation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: Robotic ablation
* Procedure: Robotic excision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotics, Laparoscopy, Endometriosis, Argon, Gynecology