Condition category
Urological and Genital Diseases
Date applied
11/12/2013
Date assigned
11/12/2013
Last edited
23/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Endometriosis is a condition where cells similar to those within the lining of the womb are found elsewhere in the body. It can be a chronic and painful condition for some women. Around 2 million women in the UK are affected by endometriosis. It is a long-term condition that causes painful or heavy periods and lower abdominal, pelvic or lower back pain. It may also lead to fertility problems.
There is no known cure for endometriosis, although symptoms may be controlled by hormone treatments or painkillers. Women who do not respond may be offered minimally invasive (keyhole) surgery to remove the diseased tissue. This treatment is applied through a special tube called a laparoscope. The standard keyhole procedure to treat this condition is laparoscopic removal or burning of tissue with electrodiathermy (a procedure in which tissue is heated to destroy abnormal cells). This can have side effects such as inadvertent injury to the bowel or the urinary system. Therefore, we aim to test the effectiveness of a relatively new treatment that involves the use of a helium beam thermo-coagulator that potentially has fewer side-effects.
This study aims to address this by directly comparing two different keyhole procedures: standard treatment (electrodiathermy) and helium thermal electro-coagulation.

Who can participate?
The study aims to recruit women between 16 years and 50 years with pelvic pain and a clinical diagnosis of mild or moderate endometriosis.

What does the study involve?
Participants will be randomly allocated to one of two groups:
1.Laparoscopic ablation/excision of mild to moderate endometriosis with helium thermal electro-coagulation
2. Laparoscopic ablation/excision of mild to moderate endometriosis with electrodiathermy
The team will assess the differences between the two procedures on the relief of symptoms, complications and quality of life for endometriosis sufferers. We will collect data from the patients before surgery and at 6 weeks, 3 months and 9 months after surgery. The study team will use the data collected to inform patients and doctors of the best choice for endometriosis surgery that has the best symptom relief and fewer complications.

What are the possible benefits and risks of participating?
It is anticipated that this study will contribute to evidence-based practice in the surgical treatment of endometriosis and will thereby allow patients to make a more informed choice of surgical intervention. More specifically, identifying the procedure that brings about superior pain relief will reduce the symptom burden of this condition and allow better targeting of treatment resources. Information on the relative complications (during and after surgery) of the two procedures will permit procedure-related morbidity to be reduced.
The risk to participants is minimal as both groups of patients will receive an intervention that is standard practice and considered to be safe.

Where is the study run from?
University Hospital of North Staffordshire NHS Trust (UK).

When is the study starting and how long is it expected to run for?
The study started in December 2013 and will run for 3 years

Who is funding the study?
National Institute for Health Research (UK).

Who is the main contact?
Dr Keira Watts
keira.watts@uhns.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Keira Watts

ORCID ID

Contact details

Academic Unit of Obstetrics and Gynaecology
Newcastle Road
Stoke-On-Trent
ST4 6QG
United Kingdom
keira.watts@uhns.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15332

Study information

Scientific title

Laparoscopic excision/ablation with a helium thermal coagulator compared with electro-diathermy for the treatment of mild to moderate endometriosis: a randomised controlled trial

Acronym

Study hypothesis

We hypothesise that laparoscopic excision/ablation of endometriosis with a helium thermal coagulator is associated with superior symptom relief and reduced morbidity compared with laparoscopic excision of endometriosis with electrodiathermy.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=15332

Ethics approval

East Midlands – Leicester, 03/10/2013, REC number 13/EM/0354

Study design

Randomised controlled interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information shee

Condition

Topic: Reproductive Health and Childb; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth

Intervention

1. Laparoscopic ablation/excision of mild to moderate endometriosis with a helium thermal coagulator
2. Laparoscopic ablation/excision of mild to moderate endometriosis with electrodiathermy

Both arms will have a follow-up schedule of 6 weeks, 3 months and 9 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pelvic Pain - VAS scores; Timepoint(s): 3 months

Secondary outcome measures

Intra-operative and post-operative complication and pregnancy rates in patients with associated subfertility. This is assessed by Quality of Life pre- and post-operatively at all follow-up visits with the Endometriosis Health Profile (EHP) 30.

Overall trial start date

02/12/2013

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged between 16 and 50 years with pelvic pain (with or without associated dyspareunia or dysmenorrhea)
2. A clinical diagnosis of mild or moderate endometriosis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 158; UK Sample Size: 158

Participant exclusion criteria

1. Possibility of gynaecological cancer
2. Advanced endometriosis
3. Pregnancy
4. Unable to give informed consent.
5. Patients currently involved in other endometriosis or pelvic pain research

Recruitment start date

02/12/2013

Recruitment end date

30/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Obstetrics and Gynaecology
Stoke-On-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

University Hospital of North Staffordshire NHS Trust (UK)

Sponsor details

Academic Research Unit
Courtyard Annexe – C Block
Newcastle Road
Stoke-on-Trent
Staffordshire
ST4 6QG
United Kingdom
research.information@uhns.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit (RfPB) (UK) ; Grant Codes: PB-PG-0212-27072

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes