The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain (ESPriT1)

The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis; Pelvic Pain
• Intervention / Treatment: Procedure: surgical removal of superficial peritoneal endometriosis

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • Royal Infirmary of Edinburgh
    • Contact: Nicola Watson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Surgical treatment	Procedure: surgical 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.
NO_INTERVENTION: No surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of women with suspected SPE undergoing diagnostic laparoscopy that were approached for the study an agreed to randomisation	The proportion of screened women who are eligible for the trial determined from the screening logs	Screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics of eligible women that agree to be randomised and those that decline participation	Baseline characteristics including age, social deprivation, ethnicity and duration of pain collected from screened women	Screening
Proportion of women having laparoscopy for investigation of chronic pelvic pain that are eligible (i.e. have only SPE) for the trial	The proportion of women undergoing diagnostic laparoscopy who go on to be diagnosed with SPE	visit 2 (day of surgery)
Effects of treatment and variability in treatment outcomes	Intraoperative and postoperative complications	visit 2 (day of surgery), 30 days post surgery
Improvement in quality of life	Endometriosis Health Profile-30 (EHP-30)	30 days post surgery, follow up at 3 and 6 months
Improvement in quality of life	Rome IV criteria	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	Pelvic Pain and Urgency/Frequency Patient (PUF) Symptom Scale	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	PainDetect TM	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	Brief Fatigue Inventory (BFI)	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	Pain Catastrophising Questionnaire (PCQ)	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	Fibromyalgia Scale	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	Measure Yourself Medical Outcome Profile 2 (MYMOP 2)	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	Working Productivity and Activity Impairment Questionnaire (WPAIQ)	day of surgery, follow up at 3 and 6 months
Improvement in quality of life	EuroQol 5 Dimensions 5 Level Questionnaire (EQ-5D-5L)	day of surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes	Number of patients who needed analgesia after laparoscopy recorded during follow up.	30 days post surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes	Number of patients who needed medical management with ovarian suppression after laparoscopy recorded during follow up.	30 days post surgery, follow up at 3 and 6 months
Effects of treatment and variability in treatment outcomes	Adverse events (as reported by the participants)	Throughout the trial starting from day of surgery until end of followup at 6 months
To determine the most acceptable methods of recruitment and assessment tools	The proportion of completed trial questionnaires	Questionnaires collected at Baseline (within a week of surgery), 3 and 6 months follow up
To determine the most acceptable methods of assessment tools	Number of patients who remained blinded for 6 months after the surgery recorded by asking patient if they were told their allocation	Throughout the trial until end of follow up at 6 months
To determine the most acceptable methods of recruitment, randomisation and assessment tools	Acceptability of the trial completed at 6 months after surgery will be compared between two arms.	6 months follow up

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: University of Nottingham; NHS Grampian

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (ACTUAL): September 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopy; endometriosis; pelvic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID Numbers: AC19062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No