Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Aarhus University Hospital, Department of Obstetrics and Gynecology
RECRUITING
Aarhus N
Regional Hospital Herning, Department of Obstetrics and Gynecology
RECRUITING
Herning
Regional Hospital Horsens, Department of Obstetrics and Gynecology
RECRUITING
Horsens
Regional Hospital Randers, Department of Obstetrics and Gynecology
RECRUITING
Randers
Regional Hospital Viborg, Department of Obstetrics and Gynecology
RECRUITING
Viborg
Contact Information
Primary
Henrik Marschall, MSc
hmars@psy.au.dk
+4522394563
Time Frame
Start Date: 2022-01-31
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 100
Treatments
Other: Active Surgery
Other: Diagnostic Surgery
Other: No-surgery control
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus
Collaborators: Aalborg University Hospital, Aarhus University Hospital