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

Mr Andrew Kent

Status

Completed

Conditions

Endometriosis

Treatments

Device: Harmonic scalpel

Device: Laser

Study type

Interventional

Funder types

Other

Identifiers

NCT02282943

EC71/02

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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