Deep Endometriosis, Endometriosis, Surgery
Conditions
Keywords
Endometriosis surgery, Deep endometriosis surgery, Robotic surgery
Brief summary
The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.
Detailed description
The objective of this prospective, randomized trial is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome at 6, 12 and 24 months postoperatively, measured by questionnaires concerning the pain symptoms and disease-related quality-of life.
Interventions
PROCEDUREMinimally invasive surgery
Minimally invasive surgery for severe deep endometriosis
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS (Numeric rating scale) Score for pain | Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively | The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Factors concerning ERAS (Enhanced recovery after surgery) | Up to 7 days (Hospital stay) | Nausea (yes/no), vomiting (yes/no), peroral intake (minutes from surgery), mobilization (minutes from surgery), bowel movement (minutes from surgery), time of discharge (hours after surgery), complications (classified according to Clavien-Dindo) for both study groups. |
| Cost | Primary hospital stay and 24 months, for both study groups. | Cost, euros. |
| Complications | 30 days | Complications (classified according to Clavien-Dindo), readmissions to hospital. |
| Intraoperative measures | Up to 300 minutes (intraoperative) | Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups. |
| General 15 dimensional health-related quality-of-life questionnaire | 6, 12 and 24 months | Quality-of-life questionnaire (15D, general quality-of-life questionnaire) described as absolute scores and change from baseline for both study groups. Scale 0-1. Score 0 equals the worst outcome and score 1 equals the best outcome. |
| Sexual quality-of-life questionnaire | 6, 12 and 24 months | Quality-of-life (FSFI, female sexual function index) described as absolute scores and change from baseline for both study groups. Scale 2,0-36,0. Score 2,0 equals the worst outcome and score 36,0 equals the best outcome. |
| Endometriosis-related quality-of-life | 6, 12 and 24 months | Quality-of-life questionnaire (EHP-30, Endometriosis-related health profile) described as absolute scores and change from the baseline. Scale 0-100. Score 0 equals the best outcome and score 100 equals the worst outcome. |
Countries
Finland
Contacts
Primary ContactAnna M Terho, MD
Backup ContactSari Koivurova, MD, PhD
Outcome results
None listed