Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
1 other identifier
interventional
112
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2002
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 5, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 26, 2019
March 1, 2019
9.2 years
October 30, 2014
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
6 months
Secondary Outcomes (3)
Quality of life survey (Endometriosis Health Profile Questionnaire)
0, 3, 6 months and 1,3,5 years
Psychological state
0, 3 ,6 months and 1,3,5 years
Visual analogue pain score (VAS) change from baseline
1,3 and 5 years
Study Arms (2)
Laser
ACTIVE COMPARATORvapourisation/excision of endometriosis using CO2 laser
Harmonic scalpel
EXPERIMENTALexcision of endometriosis using Harmonic scalpel
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mr Andrew Kentlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Kent, MD FRCOG
Royal Surrey County Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant Gynaecologist
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 5, 2014
Study Start
October 1, 2002
Primary Completion
December 1, 2011
Study Completion
June 1, 2016
Last Updated
March 26, 2019
Record last verified: 2019-03