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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted laparoscopy | Experimental | Surgery for deep endometriosis using robot-assisted laparoscopy. |
|
| Conventional laparoscopy | Active Comparator | Surgery for deep endometriosis using conventional laparoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive surgery | Procedure | Minimally invasive surgery for severe deep endometriosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS (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. | Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative measures | Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups. | Up to 300 minutes (intraoperative) |
| Factors concerning ERAS (Enhanced recovery after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna M Terho, MD | Contact | +35883153603 | anna.terho@fimnet.fi | |
| Sari Koivurova, MD, PhD | Contact | +35883153082 | sari.koivurova@fimnet.fi |
| Name | Affiliation | Role |
|---|---|---|
| Sari Koivurova, MD, PhD | Oulu University Hospital, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Ostrobothnia Hospital District | Recruiting | Oulu | 90220 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35851028 | Derived | 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. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
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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.
| Up to 7 days (Hospital stay) |
| Cost | Cost, euros. | Primary hospital stay and 24 months, for both study groups. |
| Complications | Complications (classified according to Clavien-Dindo), readmissions to hospital. | 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. | 6, 12 and 24 months |
| General 15 dimensional health-related quality-of-life questionnaire | 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. | 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. | 6, 12 and 24 months |
| D000091662 | Genital Diseases |