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OpenTrials
Completed

NCT Number: NCT02282943

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser

Device

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

Harmonic Scalpel

Device

Excision of endometriosis using Harmonic scalpel

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Quality of life survey (Endometriosis Health Profile Questionnaire)

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

  2. Psychological state

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

    Hospital Anxiety & Depression Scale

  3. Visual analogue pain score (VAS) change from baseline

    Time frame: 1,3 and 5 years

Sponsors and collaborators

Lead sponsor

Mr Andrew Kent

Other

Registry information

Important dates

Study start
2002
Primary completion
2011
Study completion
2016
First posted
Nov 5, 2014
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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