Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
| Registry | NCT05179109, acronym ROBEndo |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 70 (Estimated) |
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| Sponsor | University of Oulu (Other) |
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| Conditions | Endometriosis, Deep Endometriosis, Surgery |
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| Interventions | Minimally invasive surgery (Procedure) |
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| Dates | start 2022-10-03, primary completion 2025-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2022-01-05, last updated 2024-12-06 |
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| Locations | 1 site in Finland |
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Related Papers Related Patents Related Grants Related Experts
All trials for Endometriosis All trials for Deep Endometriosis All trials of Minimally invasive surgery
-Summary
The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Robot-assisted laparoscopy | Experimental | Procedure: Minimally invasive surgery | Surgery for deep endometriosis using robot-assisted laparoscopy. |
| Conventional laparoscopy | Active comparator | Procedure: Minimally invasive surgery | Surgery for deep endometriosis using conventional laparoscopy. |
- Minimally invasive surgery (Procedure): Minimally invasive surgery for severe deep endometriosis
+Outcome measures
Primary outcomes
- 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 outcomes
- Intraoperative measures [Up to 300 minutes (intraoperative)]: Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.
- 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.
- 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.
- 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.
+Eligibility
Sex: Female, ages: 18 Years to 50 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Northern Ostrobothnia Hospital District | Oulu | Finland | Recruiting |
+Publications
- Results publication: Terho AM, Makela-Kaikkonen J, Ohtonen P, Uimari O, Puhto T, Rautio T, Koivurova S. Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial). BMJ Open. 2022 Jul 18;12(7):e063572. doi: 10.1136/bmjopen-2022-063572. PMID 35851028
+Investigators