The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Minimally invasive surgery for severe deep endometriosis
Northern Ostrobothnia Hospital District
Oulu, Finland
RECRUITINGNRS (Numeric rating scale) Score for pain
The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups.
Time frame: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively
Intraoperative measures
Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.
Time frame: Up to 300 minutes (intraoperative)
Factors concerning ERAS (Enhanced recovery after surgery)
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.
Time frame: Up to 7 days (Hospital stay)
Cost
Cost, euros.
Time frame: Primary hospital stay and 24 months, for both study groups.
Complications
Complications (classified according to Clavien-Dindo), readmissions to hospital.
Time frame: 30 days
Endometriosis-related quality-of-life
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.
Time frame: 6, 12 and 24 months
General 15 dimensional health-related quality-of-life questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 6, 12 and 24 months
Sexual quality-of-life questionnaire
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.
Time frame: 6, 12 and 24 months