Clinical trial NCT05162794: 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
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis; Peritoneum
Keywords: Pelvic pain
Quality of life
Post-surgical neuropathic pain
Endometriosis surgery
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Aalborg University Hospital
First posted: 2021-12-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pelvic pain measured using NRS
timeFrame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Secondary outcomes:
measure: Health-related Quality of Life measured using Endometriosis Health Profile-30
timeFrame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
measure: Neuropathic pain symptoms (patient-reported) measured using painDETECT
timeFrame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
measure: Neuropathic pain symptoms (assessed) measured using quantitative sensory testing
timeFrame: Change from pre-randomization to 6 months post-randomization.
measure: Work ability measured using "Work Ability Index"
timeFrame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
measure: Worst pelvic pain measured using NRS
timeFrame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
measure: Pain frequency measured using weekly count
timeFrame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Other outcomes:
measure: Widespread pain measured using body map
timeFrame: Change from pre-randomization to 1, 3 and 6 months post-randomization.
Locations:
city: Horsens
country: Denmark
facility: Regional Hospital Horsens, Department of Obstetrics and Gynecology
state: Central Jutland Region
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Department of Obstetrics and Gynecology
city: Herning
country: Denmark
facility: Regional Hospital Herning, Department of Obstetrics and Gynecology
city: Randers
country: Denmark
facility: Regional Hospital Randers, Department of Obstetrics and Gynecology
city: Viborg
country: Denmark
facility: Regional Hospital Viborg, Department of Obstetrics and Gynecology
Study officials:
affiliation: Aarhus University, Aarhus University Hospital, Denmark
name: Axel Forman, PhD, MD
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Henrik Marschall, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Dorthe K Thomsen, PhD
role: STUDY_CHAIR
References:
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.