Back to resultsCarbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser
Harmonic scalpel
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, CO2 laser vapourisation, Harmonic scalpel, AFS stage I-III
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Laser
Harmonic scalpel
Arm Description
vapourisation/excision of endometriosis using CO2 laser
excision of endometriosis using Harmonic scalpel
Outcomes
Primary Outcome Measures
Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
Secondary Outcome Measures
Quality of life survey (Endometriosis Health Profile Questionnaire)
Psychological state
Hospital Anxiety & Depression Scale
Visual analogue pain score (VAS) change from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02282943
Brief Title
Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
Official Title
Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mr Andrew Kent
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis, CO2 laser vapourisation, Harmonic scalpel, AFS stage I-III
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser
Arm Type
Active Comparator
Arm Description
vapourisation/excision of endometriosis using CO2 laser
Arm Title
Harmonic scalpel
Arm Type
Experimental
Arm Description
excision of endometriosis using Harmonic scalpel
Intervention Type
Device
Intervention Name(s)
Laser
Intervention Description
Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser
Intervention Type
Device
Intervention Name(s)
Harmonic scalpel
Intervention Description
Excision of endometriosis using Harmonic scalpel
Primary Outcome Measure Information:
Title
Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life survey (Endometriosis Health Profile Questionnaire)
Time Frame
0, 3, 6 months and 1,3,5 years
Title
Psychological state
Description
Hospital Anxiety & Depression Scale
Time Frame
0, 3 ,6 months and 1,3,5 years
Title
Visual analogue pain score (VAS) change from baseline
Time Frame
1,3 and 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Kent, MD FRCOG
Organizational Affiliation
Royal Surrey County Hospital NHS Foundation Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
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