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Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

Primary Purpose

Endometriosis; Peritoneum

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Laparoscopy with excision
Laparoscopy without excision
Medical treatment-as-usual
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis; Peritoneum focused on measuring Pelvic pain, Quality of life, Post-surgical neuropathic pain, Endometriosis surgery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Hospital Horsens, Department of Obstetrics and GynecologyRecruiting
  • Aarhus University Hospital, Department of Obstetrics and GynecologyRecruiting
  • Regional Hospital Herning, Department of Obstetrics and GynecologyRecruiting
  • Regional Hospital Randers, Department of Obstetrics and GynecologyRecruiting
  • Regional Hospital Viborg, Department of Obstetrics and GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Active Surgery

Diagnostic Surgery

No-surgery control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Neuropathic pain symptoms (patient-reported) measured using painDETECT
Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire.
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.
Work ability measured using "Work Ability Index"
Work ability is measured using the "Work Ability Index" short questionnaire.
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.
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.

Full Information

First Posted
November 17, 2021
Last Updated
March 28, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05162794
Brief Title
Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?
Official Title
Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis; Peritoneum
Keywords
Pelvic pain, Quality of life, Post-surgical neuropathic pain, Endometriosis surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Surgery
Arm Type
Other
Arm Title
Diagnostic Surgery
Arm Type
Other
Arm Title
No-surgery control
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Laparoscopy with excision
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Laparoscopy without excision
Intervention Description
Diagnostic laparoscopy will be performed to visually confirm endometriosis in the peritoneum. However, no tissue will be excised and histology will not be performed.
Intervention Type
Other
Intervention Name(s)
Medical treatment-as-usual
Intervention Description
Patients continue their hormonal and analgesic treatment-as-usual.
Primary Outcome Measure Information:
Title
Pelvic pain measured using NRS
Description
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.
Time Frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.
Secondary Outcome Measure Information:
Title
Health-related Quality of Life measured using Endometriosis Health Profile-30
Description
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.
Time Frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.
Title
Neuropathic pain symptoms (patient-reported) measured using painDETECT
Description
Neuropathic pain symptoms (patient-reported) is measured using the validated painDETECT questionnaire.
Time Frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.
Title
Neuropathic pain symptoms (assessed) measured using quantitative sensory testing
Description
Neuropathic pain symptoms (assessed) is measured using a quantitative sensory testing battery. Allodynia, pinprick and pressure pain thresholds are measured.
Time Frame
Change from pre-randomization to 6 months post-randomization.
Title
Work ability measured using "Work Ability Index"
Description
Work ability is measured using the "Work Ability Index" short questionnaire.
Time Frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.
Title
Worst pelvic pain measured using NRS
Description
Worst pelvic pain intensity and unpleasantness will be measured on 11-point Numeric Rating Scales (0 = no pain to 10 = worst pain imaginable) weekly.
Time Frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.
Title
Pain frequency measured using weekly count
Description
Pain frequency will be measured using a weekly count, ranging from 0 days of pain to 7 days of pain.
Time Frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.
Other Pre-specified Outcome Measures:
Title
Widespread pain measured using body map
Description
Widespread pain will be measured using a body map. At each measurement point, participants will rate the areas where they experience pain.
Time Frame
Change from pre-randomization to 1, 3 and 6 months post-randomization.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Marschall, MSc
Phone
+4522394563
Email
hmars@psy.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Forman, PhD, MD
Organizational Affiliation
Aarhus University, Aarhus University Hospital, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Henrik Marschall, MSc
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dorthe K Thomsen, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Regional Hospital Horsens, Department of Obstetrics and Gynecology
City
Horsens
State/Province
Central Jutland Region
ZIP/Postal Code
DK-8700
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital, Department of Obstetrics and Gynecology
City
Aarhus N
ZIP/Postal Code
DK-8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Regional Hospital Herning, Department of Obstetrics and Gynecology
City
Herning
ZIP/Postal Code
DK-7400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Regional Hospital Randers, Department of Obstetrics and Gynecology
City
Randers
ZIP/Postal Code
DK-8930
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Regional Hospital Viborg, Department of Obstetrics and Gynecology
City
Viborg
ZIP/Postal Code
DK-8800
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36328387
Citation
Marschall H, Forman A, Lunde SJ, Kesmodel US, Hansen KE, Vase L. Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial. BMJ Open. 2022 Nov 3;12(11):e062808. doi: 10.1136/bmjopen-2022-062808.
Results Reference
derived

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Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

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