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

March 25, 2019 updated by: Mr Andrew Kent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Laser
vapourisation/excision of endometriosis using CO2 laser
Device: Laser
Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser
EXPERIMENTAL: Harmonic scalpel
excision of endometriosis using Harmonic scalpel
Device: Harmonic scalpel
Excision of endometriosis using Harmonic scalpel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mr Andrew Kent

Investigators

  • Principal Investigator: Andrew Kent, MD FRCOG, Royal Surrey County Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 1, 2014

First Posted (ESTIMATE)

November 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC71/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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