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

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Device: Laser; Device: Harmonic scalpel

• Registration Number: NCT02282943
• Lead Sponsor: Mr Andrew Kent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2011-12
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-01
• Study First Posted: 2014-11-05
• Study Completion: 2016-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Laser	vapourisation/excision of endometriosis using CO2 laser
Harmonic scalpel	Harmonic scalpel	excision of endometriosis using Harmonic scalpel

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life survey (Endometriosis Health Profile Questionnaire)	0, 3, 6 months and 1,3,5 years
Visual analogue pain score (VAS) change from baseline	1,3 and 5 years
Psychological state	0, 3 ,6 months and 1,3,5 years	Hospital Anxiety \& Depression Scale