Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

Study Overview
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Brief Summary
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The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control.

Official Title
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Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.

Conditions
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Endometriosis; Peritoneum

Intervention / Treatment
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* Other: Laparoscopy with excision
* Other: Laparoscopy without excision
* Other: Medical treatment-as-usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief Pain intensity ≥ 5 on Numeric Rating Scale (NRS) in the four weeks prior to giving consent Exclusion Criteria: Other known conditions/diseases that may cause pelvic pain Diagnosed personality disorder, schizophrenia or treatment with anti-psychotics Planned pregnancy during study period Women who cannot read or speak Danish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active Surgery<br> | Other: Laparoscopy with excision<br>* Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. Then, the relevant tissue will be excised and a histology will be performed.<br>Other: Medical treatment-as-usual<br>* Patients continue their hormonal and analgesic treatment-as-usual.<br>|
| Other: Diagnostic Surgery<br> | Other: Laparoscopy without excision<br>* Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.<br>Other: Medical treatment-as-usual<br>* Patients continue their hormonal and analgesic treatment-as-usual.<br>|
| Other: No-surgery control<br> | Other: Medical treatment-as-usual<br>* Patients continue their hormonal and analgesic treatment-as-usual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic pain measured using NRS | Pelvic pain intensity (sensory) and unpleasantness (affective) will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly. | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life measured using Endometriosis Health Profile-30 | Quality of Life will be measured using the validated and patient-generated, endometriosis-specific questionnaire Endometriosis Health Profile 30, consisting of 30 questions rated on Likert scales. | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 
| Neuropathic pain symptoms (patient-reported) measured using painDETECT | Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire. | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 
| Neuropathic pain symptoms (assessed) measured using quantitative sensory testing | Neuropathic pain symptoms (assessed) is measured using a quantitative sensory testing battery. Allodynia, pinprick and pressure pain thresholds are measured. | Change from pre-randomization to 6 months post-randomization. | 
| Work ability measured using Work Ability Index | Work ability is measured using the Work Ability Index short questionnaire. | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 
| Worst pelvic pain measured using NRS | Worst pelvic pain intensity and unpleasantness will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly. | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 
| Pain frequency measured using weekly count | Pain frequency will be measured using a weekly count, ranging from 0 days of pain to 7 days of pain. | Change from pre-randomization to 1, 3 and 6 months post-randomization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic pain, Quality of life, Post-surgical neuropathic pain, Endometriosis surgery