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

NCT ID: NCT02282943

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2016-06-30

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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laser

vapourisation/excision of endometriosis using CO2 laser

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type DEVICE

Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser

Harmonic scalpel

excision of endometriosis using Harmonic scalpel

Group Type EXPERIMENTAL

Harmonic scalpel

Intervention Type DEVICE

Excision of endometriosis using Harmonic scalpel

Interventions

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Laser

Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser

Intervention Type DEVICE

Harmonic scalpel

Excision of endometriosis using Harmonic scalpel

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mr Andrew Kent

OTHER

Sponsor Role lead

Responsible Party

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Mr Andrew Kent

Consultant Gynaecologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew Kent, MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

Royal Surrey County Hospital NHS Foundation Trust

Other Identifiers

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EC71/02

Identifier Type: -

Identifier Source: org_study_id

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