Evaluating laparoscopic surgery for peritoneal endometriosis
Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful: A Double-blind, Randomized, Controlled, Three-armed Surgical Trial.
NA · University of Aarhus · NCT05162794
This study is testing whether a minimally invasive surgery for endometriosis can help reduce pelvic pain and improve quality of life compared to other options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Aarhus (other) |
| Locations | 5 sites (Horsens, Central Jutland and 4 other locations) |
| Trial ID | NCT05162794 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of laparoscopic excision of peritoneal endometriosis on pelvic pain, quality of life, and post-surgical neuropathic pain. Participants will be randomly assigned to one of three groups: laparoscopic excision of endometrial tissue, laparoscopic procedure without excision, or a waiting list control. The study aims to determine whether surgical intervention provides significant benefits compared to non-surgical options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with suspected peritoneal endometriosis and significant pelvic pain.
Not a fit: Patients with other known conditions causing pelvic pain or those with psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and quality of life for patients suffering from endometriosis.
How similar studies have performed: Other studies have shown promising results with laparoscopic interventions for endometriosis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Horsens, Central Jutland and 4 other locations
- Regional Hospital Horsens, Department of Obstetrics and Gynecology — Horsens, Central Jutland, Denmark (RECRUITING)
- Aarhus University Hospital, Department of Obstetrics and Gynecology — Aarhus N, Denmark (RECRUITING)
- Regional Hospital Herning, Department of Obstetrics and Gynecology — Herning, Denmark (RECRUITING)
- Regional Hospital Randers, Department of Obstetrics and Gynecology — Randers, Denmark (RECRUITING)
- Regional Hospital Viborg, Department of Obstetrics and Gynecology — Viborg, Denmark (RECRUITING)
Study contacts
- Principal investigator: Henrik Marschall, MSc — University of Aarhus
- Study coordinator: Henrik Marschall, MSc
- Email: hmars@psy.au.dk
- Phone: +4522394563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, Peritoneum, Pelvic pain, Quality of life, Post-surgical neuropathic pain, Endometriosis surgery