Comparing robotic and laparoscopic surgery for deep endometriosis
Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
This study is testing whether robot-assisted surgery is better than regular laparoscopic surgery for people with deep endometriosis in terms of pain relief and quality of life after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Oulu Academic / other |
| Locations | 1 site (Oulu) |
| Trial ID | NCT05179109 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if robot-assisted laparoscopy provides better patient outcomes than conventional laparoscopy for individuals with deep endometriosis. It is a prospective, randomized trial that will assess outcomes at 6, 12, and 24 months post-surgery. Patient outcomes will be measured using questionnaires focused on pain symptoms and quality of life related to the disease. The study involves minimally invasive surgical techniques to treat the condition.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with deep endometriosis who are experiencing symptoms and require surgical intervention.
Not a fit: Patients with a higher ASA classification (greater than 3) or recurring rectosigmoid endometriosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with deep endometriosis.
How similar studies have performed: Other studies have shown promising results with robotic surgery approaches, suggesting potential benefits, but this specific comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA (American Society of Anesthesiologists physical status classification) 1-3 * Diagnosed deep endometriosis (MRI) * Patient has symptoms * Operative treatment is indicated * Patient is able to give informed consent Exclusion Criteria: * ASA \> 3 * Recurring rectosigmoid endometriosis
Where this trial is running
Oulu
- Northern Ostrobothnia Hospital District — Oulu, Finland (Recruiting)
Study contacts
- Principal investigator: Sari Koivurova, MD, PhD — Oulu University Hospital, Department of Obstetrics and Gynecology
- Study coordinator: Anna M Terho, MD
- Email: anna.terho@fimnet.fi
- Phone: +35883153603
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.