Helium thermocoagulation versus electrodiathermy for endometriosis

ISRCTN	ISRCTN50928834
DOI	https://doi.org/10.1186/ISRCTN50928834
Secondary identifying numbers	15332

Submission date: 11/12/2013
Registration date: 11/12/2013
Last edited: 07/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 finish in September 2018

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

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

Contact information

Dr Keira Watts
Scientific

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

Email	keira.watts@uhns.nhs.uk

Study information

Study design	Randomised controlled interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information shee
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
Study objectives	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(s)	East Midlands Leicester, 03/10/2013, REC number 13/EM/0354
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	02/12/2013
Completion date	30/09/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 158; UK Sample Size: 158
Total final enrolment	192
Key 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
Key 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
Date of first enrolment	02/12/2013
Date of final enrolment	01/10/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Unit of Obstetrics and Gynaecology

Stoke-On-Trent
ST4 6QG
United Kingdom

Sponsor information

University Hospital of North Staffordshire NHS Trust (UK)
Hospital/treatment centre

Academic Research Unit
Courtyard Annexe C Block
Newcastle Road
Stoke-on-Trent
Staffordshire
ST4 6QG
England
United Kingdom

Email	research.information@uhns.nhs.uk

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/11/2020	07/05/2021	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

07/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
15/01/2018: The recruitment end date was changed from 30/12/2016 to 01/10/2017.
The overall trial end date was changed from 30/12/2016 to 30/09/2018.