EndometriosisNCT02282943
Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
A study testing Laser and Harmonic scalpel in people with Endometriosis, run by Mr Andrew Kent.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Laser and Harmonic scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Endometriosis
- Being tested
- Laser, Harmonic scalpel
- Keywords
- endometriosis, CO2 laser vapourisation, Harmonic scalpel, AFS stage I-III
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser
Harmonic scalpelDevice
Excision of endometriosis using Harmonic scalpel
| Study group | Role | What they receive |
|---|---|---|
| Laser | Active comparator | vapourisation/excision of endometriosis using CO2 laser Receives: Device: Laser |
| Harmonic scalpel | Experimental | excision of endometriosis using Harmonic scalpel Receives: Device: Harmonic scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
Measured: 6 months
Secondary outcomes (3)
Quality of life survey (Endometriosis Health Profile Questionnaire)
Measured: 0, 3, 6 months and 1,3,5 years
Psychological state
Hospital Anxiety \& Depression Scale
Measured: 0, 3 ,6 months and 1,3,5 years
Visual analogue pain score (VAS) change from baseline
Measured: 1,3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startOct 2002
- Primary completionDec 2011
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mr Andrew Kent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mr Andrew Kent, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Andrew Kent, MD FRCOG, Principal investigator, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282943
- Sponsor's protocol ID
- EC71/02
- Status last verified
- Mar 2019
- First submitted
- 30 Oct 2014
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
- ClinicalTrials.gov ID
- NCT02282943
- Acronym / sponsor ID
- EC71/02
- Conditions
- Endometriosis
- Keywords
- endometriosis, CO2 laser vapourisation, Harmonic scalpel, AFS stage I-III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mr Andrew KentUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Active comparator | Device: Laservapourisation/excision of endometriosis using CO2 laser |
| Harmonic scalpel | Experimental | Device: Harmonic scalpelexcision of endometriosis using Harmonic scalpel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserVapourisation/excision of endometriosis AFS stages I-III using CO2 laser | Device | Laser |
| Harmonic scalpelExcision of endometriosis using Harmonic scalpel | Device | Harmonic scalpel |
Primary outcome
Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
Time frame: 6 months
3 secondary outcomes
Quality of life survey (Endometriosis Health Profile Questionnaire)
Time frame: 0, 3, 6 months and 1,3,5 years
Psychological state
Time frame: 0, 3 ,6 months and 1,3,5 years
Visual analogue pain score (VAS) change from baseline
Time frame: 1,3 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Kent, MD FRCOG principal investigator
Royal Surrey County Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Harmonic scalpel in people with Endometriosis, run by Mr Andrew Kent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.