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

Endometriosis Clinical Trial

— ESPriT1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081532
• Other study ID #: AC19062
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: August 2020

Study information

• Verified date: December 2019
• Source: University of Edinburgh
• Contact: Ann M Doust
• Phone: 01312429492
• Email: Ann.Doust[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Grampian, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	Effects of treatment and variability in treatment outcomes	Intraoperative and postoperative complications	visit 2 (day of surgery), 30 days post surgery
Secondary	Improvement in quality of life	Endometriosis Health Profile-30 (EHP-30)	30 days post surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	Rome IV criteria	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	Pelvic Pain and Urgency/Frequency Patient (PUF) Symptom Scale	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	PainDetect TM	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	Brief Fatigue Inventory (BFI)	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	Pain Catastrophising Questionnaire (PCQ)	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	Fibromyalgia Scale	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	Measure Yourself Medical Outcome Profile 2 (MYMOP 2)	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	Working Productivity and Activity Impairment Questionnaire (WPAIQ)	day of surgery, follow up at 3 and 6 months
Secondary	Improvement in quality of life	EuroQol 5 Dimensions 5 Level Questionnaire (EQ-5D-5L)	day of surgery, follow up at 3 and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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