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