Helium thermocoagulation versus electrosurgery for endometriosis.
Research type
Research Study
Full title
Laparoscopic excision/ablation with Helium Thermal Coagulator compared with electro-diathermy for the treatment of mild to moderate endometriosis: a randomised controlled trial.
IRAS ID
132906
Contact name
Gourab Misra
Contact email
Sponsor organisation
University Hospital of North Midlands NHS Trust
Research summary
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 efficacy of a relatively new treatment that involves the use of a helium
beam thermo-coaugulator that has potentially fewer side-effects.
This study aims to address this by running a trial that will directly compare 2
different keyhole procedures; standard treatment (electrodiathermy) and
helium thermal electro-coagulation. The team will assess the differences of the
2 procedures on the relief of symptoms, intra and post-operative complications
and quality of life for endometriosis sufferers. We will collect data from the
patients before surgery and 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. The results will have implications for improving future
patient care of endometriosis sufferers with mild-moderate disease.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0354
Date of REC Opinion
18 Sep 2013
REC opinion
Favourable Opinion