Title: Laparoscopic excision/ablation with helium thermal coagulator compared with electro-diathermy for the treatment of mild to moderate endometriosis: a randomised controlled trial.
Funder: Department of Health and Social Care

Abstract: Background: Endometriosis is defined as the presence of glandular and stromal tissue outside the uterus. It is estimated to be present in approximately 10% of the population but in women with pelvic pain the incidence ranges from 20% to 90%. Endometriosis affects approximately 2 million women in the UK. It can be a chronic and debilitating condition. Laparoscopy is the gold standard diagnostic test in clinical practice (Wykes et al 2004). Surgical treatment of diseased tissue can take place at the same time as the diagnostic laparoscopy. There is evidence to suggest that pain and quality of life (QoL) improve following laparoscopic surgery of endometriosis. Abbott et al (2004) in a randomized, blinded crossover study compared laparoscopic surgery with placebo surgery, including all stages of endometriosis. Main outcome measures were change in visual analogue pain score, quality of life and sexual health questionnaire. Symptom relief was significantly higher in the excisional surgery group compared to the placebo group (80% vs. 32%). QoL also significantly improved following excisional surgery. Approximately 20% of women had no improvement following surgery. The optimal treatment of mild to moderate endometriosis is still in dispute today. This is due to the high number of recurrences of the disease and the adverse effects of hormone therapy. A systematic review of the literature recovered a structured literature review (NICE), a low quality randomized clinical trial and eight case series. The case series represent the lowest degree of evidence. With no control group, the effectiveness of the helium technique derived from studies with this design cannot be determined definitively. Aims: To determine whether laparoscopic excision/ablation of endometriosis with helium thermal coagulator is associated with superior symptom relief and reduced morbidity compared with laparoscopic excision of endometriosis with electrodiathermy. Outcome measures: The primary outcome measure is non-cyclical pelvic pain. Secondary outcome measures are quality of life (QoL), dysmenorrhoea, deep dyspareunia, intra-operative complications, post-operative complications, and pregnancy rates in patients with associated subfertility. QoL will be assessed pre- and post-operatively at all follow up visits with the EHP 30 (Endometriosis Health Profile); this the only validated QoL measure in patients with endometriosis. Plan of investigation: We propose to set up a double-blinded randomized controlled trial comparing the treatment effects of laparoscopic excision of endometriosis with helium thermal coagulator versus electrodiathermy in the treatment of mild to moderate endometriosis. Subjects: Patients between 16yrs and 50yrs with pelvic pain (with or without associated dyspareunia or dysmenorrhea) and a clinical diagnosis of mild or moderate endometriosis. Exclusion criteria: Possibility of gynaecological cancer Advanced endometriosis Pregnancy. Assessment of symptoms and study outcome measures will occur pre-operatively and follow up will be at intervals of 6 weeks, 3 months and 9 months post-operatively. To minimize selection bias, allocation concealment by third-party randomization has been chosen. Once the subject is in the operating theatre the surgeon will log in to the randomization service at the York Clinical Trials Unit and obtain the code of the procedure to be performed. Benefits: 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 intra- and post-operative complications of the two procedures will permit procedure-related morbidity to be reduced.

Lay abstract: 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.

Research activity codes: 6.4 SURGERY
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH