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

Not Applicable

Completed

• Conditions: Pelvic Pain; Endometriosis
• Interventions: Procedure: surgical removal of superficial peritoneal endometriosis

• Registration Number: NCT04081532
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Study Start: 2019-09-30
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment	surgical removal of superficial peritoneal endometriosis	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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	Throughout the trial starting from day of surgery until end of followup at 6 months	Adverse events (as reported by the participants)
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
Improvement in quality of life	day of surgery, follow up at 3 and 6 months	EuroQol 5 Dimensions 5 Level Questionnaire (EQ-5D-5L)

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom