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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282943
• Other study ID #: EC71/02
• Status: Completed
• Phase: N/A
• Start date: October 2002
• Est. completion date: June 2016

Study information

• Verified date: March 2019
• Source: Royal Surrey County Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2016
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Device:
• Laser
Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser
• Harmonic scalpel
Excision of endometriosis using Harmonic scalpel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mr Andrew Kent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline		6 months
Secondary	Quality of life survey (Endometriosis Health Profile Questionnaire)		0, 3, 6 months and 1,3,5 years
Secondary	Psychological state	Hospital Anxiety & Depression Scale	0, 3 ,6 months and 1,3,5 years
Secondary	Visual analogue pain score (VAS) change from baseline		1,3 and 5 years