Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis

Study Overview
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Brief Summary
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The purpose of this study is to compare laser CO2 ablation/excision of Endometriosis (AFS stages 1-3) with excision of endometriosis using the Ethicon Harmonic ACE device. Pain scores at 6 months was the primary outcome, but secondary outcomes assessed pain scores at 1, 3 and 5 years as well as psychological state and quality of life.

Official Title
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Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Device: Laser
* Device: Harmonic scalpel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endometriosis grade I-III by revised American Fertility Society Scoring Patients in whom laser treatment to the endometriosis is considered the treatment of choice. Patients having consented to participated in the trial Patient is 18 years old or greater Patients who have no contraindications to either of the treatment modalities proposed Exclusion Criteria: Patients who do not wish to participate/have not signed the informed consent form Pregnancy of breast feeding Patients who are unable or unwilling to discontinue hormonal treatment for 6 months Patients who have received additional treatment for their endometriosis within 6 months of surgery Patients with documented painful conditions of the gastrointestinal or urinary system

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser<br>vapourisation/excision of endometriosis using CO2 laser | Device: Laser<br>* Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser<br>|
| Experimental: Harmonic scalpel<br>excision of endometriosis using Harmonic scalpel | Device: Harmonic scalpel<br>* Excision of endometriosis using Harmonic scalpel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life survey (Endometriosis Health Profile Questionnaire) |  | 0, 3, 6 months and 1,3,5 years | 
| Psychological state | Hospital Anxiety & Depression Scale | 0, 3 ,6 months and 1,3,5 years | 
| Visual analogue pain score (VAS) change from baseline |  | 1,3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Harmonic scalpel, CO2 laser vapourisation, AFS stage I-III, endometriosis