Carbon Dioxide-laser Versus Harmonic Scalpel in the Treat... | NCT02282943

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

NCT02282943

Sponsor

Mr Andrew Kent

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

112Actual

Phase

Not Applicable

Conditions

Endometriosis

Interventions

Laser
Harmonic scalpel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Dec 2011Actual

Completion Date

Jun 2016Actual

First Submitted Date

Oct 30, 2014

First Submission Date that Met QC Criteria

Nov 1, 2014

First Posted Date

Nov 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2019

Last Update Posted Date

Mar 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mr Andrew Kent, Consultant Gynaecologist, Royal Surrey County Hospital NHS Foundation TrustSponsor-Investigator

Lead Sponsor

Mr Andrew KentOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser	Active Comparator	vapourisation/excision of endometriosis using CO2 laser	Device: Laser
Harmonic scalpel	Experimental	excision of endometriosis using Harmonic scalpel	Device: Harmonic scalpel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser	Device	Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser	Laser

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Quality of life survey (Endometriosis Health Profile Questionnaire)		0, 3, 6 months and 1,3,5 years
Psychological state	Hospital Anxiety & Depression Scale	0, 3 ,6 months and 1,3,5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Kent, MD FRCOG	Royal Surrey County Hospital NHS Foundation Trust	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007834	Lasers

Ancestor Terms

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided