Endometriosis, Pelvic Pain
Conditions
Keywords
endometriosis, laparoscopy, pelvic pain
Brief summary
Endometriosis is a chronic, incurable condition that affects about 10% of women of reproductive age. It is defined as a growth of cells similar to the womb lining outside of the womb in the pelvis, and is associated with chronic pelvic pain, excessive period pain, pain with sexual intercourse and difficulties in getting pregnant. If the disease is found only on the lining of the pelvis it is known as superficial peritoneal and is usually treated during a laparoscopic surgery by cutting out (excision) or burning off (ablation). However, many women do not find improvement in their symptoms after the surgery and can have complications from the procedure. The aim of this study is to determine if removal of the superficial peritoneal endometriosis improves pain symptoms and quality of life, which method of removal (excision or ablation) is more effective or if surgical removal is of no benefit to the patients and can potentially cause harm. The investigators plan to recruit up to 90 women from four NHS hospitals in Scotland over a period of 12 months. Women who are attending gynaecology departments with pelvic pain who have not previously had a diagnosis of endometriosis via laparoscopy will be approached. Patients will be asked to read an information sheet about the trial. Women who consent to the trial will be randomised during the surgery, if superficial endometriosis is found, to either having the endometriosis removed or not. For this pilot, follow up will be at 3 and 6 months (and obtain permission to continue to follow them up at 12 and 24 months should time and finding permit). Patients who do not consent to take part in the trial will be asked if the investigators can collect data on their demographics and reasons on why they did not wish to take part.
Interventions
PROCEDUREsurgical removal of superficial peritoneal endometriosis
In the active comparator group patients will have endometriosis lesions removed by ablation or excision. Patients randomised to no surgical treatment arm will not have lesions removed and will only be given diagnosis on whether endometriosis was found or not.
Sponsors
NHS Grampian
University of Nottingham
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
General Practitioner
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing laparoscopy for the investigation of chronic pelvic pain * In order to be randomised, isolated superficial peritoneal endometriosis (SPE) must be identified at laparoscopy (macroscopically) * Able to give informed consent
Exclusion criteria
* Previous surgical diagnosis of endometriosis * Pregnant or are actively trying for pregnancy within the next six months * Deep endometriosis or ovarian endometrioma on imaging or at laparoscopy * Peritoneal 'pockets' only noted at laparoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women with suspected SPE undergoing diagnostic laparoscopy that were approached for the study an agreed to randomisation | Screening | The proportion of screened women who are eligible for the trial determined from the screening logs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women having laparoscopy for investigation of chronic pelvic pain that are eligible (i.e. have only SPE) for the trial | visit 2 (day of surgery) | The proportion of women undergoing diagnostic laparoscopy who go on to be diagnosed with SPE |
| Effects of treatment and variability in treatment outcomes | visit 2 (day of surgery), 30 days post surgery | Intraoperative and postoperative complications |
| Improvement in quality of life | 30 days post surgery, follow up at 3 and 6 months | Endometriosis Health Profile-30 (EHP-30) |
| Baseline characteristics of eligible women that agree to be randomised and those that decline participation | Screening | Baseline characteristics including age, social deprivation, ethnicity and duration of pain collected from screened women |
| To determine the most acceptable methods of assessment tools | Throughout the trial until end of follow up at 6 months | Number of patients who remained blinded for 6 months after the surgery recorded by asking patient if they were told their allocation |
| To determine the most acceptable methods of recruitment, randomisation and assessment tools | 6 months follow up | Acceptability of the trial completed at 6 months after surgery will be compared between two arms. |
| To determine the most acceptable methods of recruitment and assessment tools | Questionnaires collected at Baseline (within a week of surgery), 3 and 6 months follow up | The proportion of completed trial questionnaires |
Countries
United Kingdom
Outcome results
None listed