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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometriosis, Pelvic Pain

Intervention / Treatment
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* Procedure: surgical removal of superficial peritoneal endometriosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical treatment<br> | Procedure: surgical removal of superficial peritoneal endometriosis<br>* 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.<br>|
| No Intervention: No surgical treatment<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, laparoscopy, pelvic pain