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

Mr Andrew Kent112 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

Endometriosis

Interventions

LaserDEVICE

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

Harmonic scalpelDEVICE

Excision of endometriosis using Harmonic scalpel

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline

Time frame: 6 months

Secondary Outcomes

Quality of life survey (Endometriosis Health Profile Questionnaire)

Time frame: 0, 3, 6 months and 1,3,5 years

Psychological state

Hospital Anxiety \& Depression Scale

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

Data from ClinicalTrials.gov

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