Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
NCT Number: NCT04081532
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.
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Notify Me18 year–55 year
Female
Interventional
Not applicable
Edinburgh, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Screening
The proportion of screened women who are eligible for the trial determined from the screening logs
Time frame: Screening
Baseline characteristics including age, social deprivation, ethnicity and duration of pain collected from screened women
Time frame: visit 2 (day of surgery)
The proportion of women undergoing diagnostic laparoscopy who go on to be diagnosed with SPE
Time frame: visit 2 (day of surgery), 30 days post surgery
Intraoperative and postoperative complications
Time frame: 30 days post surgery, follow up at 3 and 6 months
Endometriosis Health Profile-30 (EHP-30)
Time frame: day of surgery, follow up at 3 and 6 months
Rome IV criteria
Time frame: day of surgery, follow up at 3 and 6 months
Pelvic Pain and Urgency/Frequency Patient (PUF) Symptom Scale
Time frame: day of surgery, follow up at 3 and 6 months
PainDetect TM
Time frame: day of surgery, follow up at 3 and 6 months
Brief Fatigue Inventory (BFI)
Time frame: day of surgery, follow up at 3 and 6 months
Pain Catastrophising Questionnaire (PCQ)
Time frame: day of surgery, follow up at 3 and 6 months
Fibromyalgia Scale
Time frame: day of surgery, follow up at 3 and 6 months
Measure Yourself Medical Outcome Profile 2 (MYMOP 2)
Time frame: day of surgery, follow up at 3 and 6 months
Working Productivity and Activity Impairment Questionnaire (WPAIQ)
Time frame: day of surgery, follow up at 3 and 6 months
EuroQol 5 Dimensions 5 Level Questionnaire (EQ-5D-5L)
Time frame: 30 days post surgery, follow up at 3 and 6 months
Number of patients who needed analgesia after laparoscopy recorded during follow up.
Time frame: 30 days post surgery, follow up at 3 and 6 months
Number of patients who needed medical management with ovarian suppression after laparoscopy recorded during follow up.
Time frame: Throughout the trial starting from day of surgery until end of followup at 6 months
Adverse events (as reported by the participants)
Time frame: Questionnaires collected at Baseline (within a week of surgery), 3 and 6 months follow up
The proportion of completed trial questionnaires
Time frame: 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
Time frame: 6 months follow up
Acceptability of the trial completed at 6 months after surgery will be compared between two arms.
University of Edinburgh
Other
The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial
Acronym: ESPriT1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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