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 designRandomised controlled interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information shee
Scientific titleLaparoscopic excision/ablation with a helium thermal coagulator compared with electro-diathermy for the treatment of mild to moderate endometriosis: a randomised controlled trial
Study objectivesWe 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) studiedTopic: Reproductive Health and Childb; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth
Intervention1. 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 typeOther
Primary outcome measurePelvic Pain - VAS scores; Timepoint(s): 3 months
Secondary outcome measuresIntra-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 date02/12/2013
Completion date30/09/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsPlanned Sample Size: 158; UK Sample Size: 158
Total final enrolment192
Key inclusion criteria1. 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 criteria1. 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 enrolment02/12/2013
Date of final enrolment01/10/2017

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.