Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial)
Introduction Endometriosis is a common gynaecological disease affecting around 10% of fertile-aged women, causing severe pain symptoms. Deep endometriosis is defined as endometriotic implants that infiltrate the underlying organs more than 5 mm in depth. Surgery for deep endometriosis requires advan...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e063572.full |
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| author | Tero Rautio Pasi Ohtonen Outi Uimari Anna Maria Terho Johanna Mäkelä-Kaikkonen Terhi Puhto Sari Koivurova |
| author_facet | Tero Rautio Pasi Ohtonen Outi Uimari Anna Maria Terho Johanna Mäkelä-Kaikkonen Terhi Puhto Sari Koivurova |
| author_sort | Tero Rautio |
| collection | DOAJ |
| description | Introduction Endometriosis is a common gynaecological disease affecting around 10% of fertile-aged women, causing severe pain symptoms. Deep endometriosis is defined as endometriotic implants that infiltrate the underlying organs more than 5 mm in depth. Surgery for deep endometriosis requires advanced multidisciplinary surgical technique, often in very difficult surgical conditions, with increased risks of complications. Robotic surgery offers a high-definition three-dimensional view and articulating instruments that may allow more precise dissection than conventional laparoscopy in the pelvic area. The superiority of robotic surgery has not, however, been provedin randomised controlled studies, and there is a lack of long-term outcome data. Advanced endometriosis surgery offers an excellent platform to study the feasibility and long-term outcomes of robotic surgery compared with conventional laparoscopy.Methods and analysis ROBEndo is a prospective, randomised, controlled clinical trial in a single-centre setting. Patients with deep endometriosis verified by MRI needing surgery at Oulu University Hospital (Oulu, Finland) will be considered eligible. 70 patients will be allocated 1:1 to receive either robotic-assisted or conventional laparoscopic surgery in two strata: radical surgery (with the removal of the uterus and adnexae) and gynaecological organ-sparing surgery. The primary outcome will be the surgical outcome as regards to pain symptoms measured on numeric rating scale (NRS) questionnaires at 24 hours and 6, 12 and 24 months postoperatively. As secondary outcomes, intraoperative measures, enhanced recovery after surgery factors, complications, cost and long-term quality of life measured with Endometriosis Health Profile-30 (EHP-30), Female Sexual Function Index (FSFI) and 15-dimensional (15D) questionnaires will be compared.Ethics and dissemination This study has been approved by the Northern Ostrobothnian Hospital District Ethical Committee at Oulu University Hospital (212/2021). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be published in peer-reviewed international journals.Trial registration number NCT05179109. |
| format | Article |
| id | doaj-art-bd583d77e4324e4494398672e4c95584 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-bd583d77e4324e4494398672e4c955842025-01-31T16:50:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-063572Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial)Tero Rautio0Pasi Ohtonen1Outi Uimari2Anna Maria Terho3Johanna Mäkelä-Kaikkonen4Terhi Puhto5Sari Koivurova6Department of Surgery, Research Unit of Surgery, Anesthesia and Intensive Care, Oulu University Hospital, University of Oulu, Oulu, FinlandDepartment of Surgery, Oulu University Hospital, Oulu, FinlandDepartment of Obstetrics and Gynaecology, PEDEGO Research Unit and Medical Research Center Oulu, Oulu University Hospital, University of Oulu, Oulu, FinlandDepartment of Obstetrics and Gynaecology, PEDEGO Research Unit and Medical Research Center Oulu, Oulu University Hospital, University of Oulu, Oulu, FinlandDepartment of Surgery, Research Unit of Surgery, Anesthesia and Intensive Care, Oulu University Hospital, University of Oulu, Oulu, FinlandDepartment of Surgery, Research Unit of Surgery, Anesthesia and Intensive Care, Oulu University Hospital, University of Oulu, Oulu, FinlandDepartment of Obstetrics and Gynaecology, PEDEGO Research Unit and Medical Research Center Oulu, Oulu University Hospital, University of Oulu, Oulu, FinlandIntroduction Endometriosis is a common gynaecological disease affecting around 10% of fertile-aged women, causing severe pain symptoms. Deep endometriosis is defined as endometriotic implants that infiltrate the underlying organs more than 5 mm in depth. Surgery for deep endometriosis requires advanced multidisciplinary surgical technique, often in very difficult surgical conditions, with increased risks of complications. Robotic surgery offers a high-definition three-dimensional view and articulating instruments that may allow more precise dissection than conventional laparoscopy in the pelvic area. The superiority of robotic surgery has not, however, been provedin randomised controlled studies, and there is a lack of long-term outcome data. Advanced endometriosis surgery offers an excellent platform to study the feasibility and long-term outcomes of robotic surgery compared with conventional laparoscopy.Methods and analysis ROBEndo is a prospective, randomised, controlled clinical trial in a single-centre setting. Patients with deep endometriosis verified by MRI needing surgery at Oulu University Hospital (Oulu, Finland) will be considered eligible. 70 patients will be allocated 1:1 to receive either robotic-assisted or conventional laparoscopic surgery in two strata: radical surgery (with the removal of the uterus and adnexae) and gynaecological organ-sparing surgery. The primary outcome will be the surgical outcome as regards to pain symptoms measured on numeric rating scale (NRS) questionnaires at 24 hours and 6, 12 and 24 months postoperatively. As secondary outcomes, intraoperative measures, enhanced recovery after surgery factors, complications, cost and long-term quality of life measured with Endometriosis Health Profile-30 (EHP-30), Female Sexual Function Index (FSFI) and 15-dimensional (15D) questionnaires will be compared.Ethics and dissemination This study has been approved by the Northern Ostrobothnian Hospital District Ethical Committee at Oulu University Hospital (212/2021). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be published in peer-reviewed international journals.Trial registration number NCT05179109.https://bmjopen.bmj.com/content/12/7/e063572.full |
| spellingShingle | Tero Rautio Pasi Ohtonen Outi Uimari Anna Maria Terho Johanna Mäkelä-Kaikkonen Terhi Puhto Sari Koivurova Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial) BMJ Open |
| title | Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial) |
| title_full | Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial) |
| title_fullStr | Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial) |
| title_full_unstemmed | Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial) |
| title_short | Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial) |
| title_sort | robotic versus laparoscopic surgery for severe deep endometriosis protocol for a randomised controlled trial robendo trial |
| url | https://bmjopen.bmj.com/content/12/7/e063572.full |
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