Clinical trial NCT04081532: The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
Official title: The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Keywords: endometriosis
laparoscopy
pelvic pain
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Grampian
name: University of Nottingham
First posted: 2019-09-09
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women with suspected SPE undergoing diagnostic laparoscopy that were approached for the study an agreed to randomisation
timeFrame: Screening
Secondary outcomes:
measure: Baseline characteristics of eligible women that agree to be randomised and those that decline participation
timeFrame: Screening
measure: Proportion of women having laparoscopy for investigation of chronic pelvic pain that are eligible (i.e. have only SPE) for the trial
timeFrame: visit 2 (day of surgery)
measure: Effects of treatment and variability in treatment outcomes
timeFrame: visit 2 (day of surgery), 30 days post surgery
measure: Improvement in quality of life
timeFrame: 30 days post surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Improvement in quality of life
timeFrame: day of surgery, follow up at 3 and 6 months
measure: Effects of treatment and variability in treatment outcomes
timeFrame: 30 days post surgery, follow up at 3 and 6 months
measure: Effects of treatment and variability in treatment outcomes
timeFrame: 30 days post surgery, follow up at 3 and 6 months
measure: Effects of treatment and variability in treatment outcomes
timeFrame: Throughout the trial starting from day of surgery until end of followup at 6 months
measure: To determine the most acceptable methods of recruitment and assessment tools
timeFrame: Questionnaires collected at Baseline (within a week of surgery), 3 and 6 months follow up
measure: To determine the most acceptable methods of assessment tools
timeFrame: Throughout the trial until end of follow up at 6 months
measure: To determine the most acceptable methods of recruitment, randomisation and assessment tools
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: Andrew W Horne, Prof
role: STUDY_CHAIR
References:
citation: Whitaker LHR, Doust A, Stephen J, Norrie J, Cooper K, Daniels J, Hummelshoj L, Cox E, Beatty L, Chien P, Madhra M, Vincent K, Horne AW. Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1). Pilot Feasibility Stud. 2021 Jan 7;7(1):19. doi: 10.1186/s40814-020-00740-9.