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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02282943

Enrollment

112

Registered

2014-11-05

Start date

2002-10-31

Completion date

2016-06-30

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

endometriosis, CO2 laser vapourisation, Harmonic scalpel, AFS stage I-III

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.

Interventions

DEVICELaser

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

DEVICEHarmonic scalpel

Excision of endometriosis using Harmonic scalpel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	Hospital Anxiety & Depression Scale
Visual analogue pain score (VAS) change from baseline	1,3 and 5 years	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026