University of Oulu

Terho AM, Mäkelä-Kaikkonen J, Ohtonen P, et al. Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial). BMJ Open 2022;12:e063572. doi:10.1136/bmjopen-2022-063572

Robotic versus laparoscopic surgery for severe deep endometriosis : protocol for a randomised controlled trial (ROBEndo trial)

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Author: Terho, Anna Maria1; Mäkelä-Kaikkonen, Johanna2; Ohtonen, Pasi2;
Organizations: 1Department of Obstetrics and Gynaecology, PEDEGO Research Unit and Medical Research Center Oulu, Oulu University Hospital, University of Oulu, Oulu, Finland
2Department of Surgery, Research Unit of Surgery, Anesthesia and Intensive Care, Oulu University Hospital, University of Oulu, Oulu, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.3 MB)
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Language: English
Published: BMJ, 2022
Publish Date: 2023-04-06


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.

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Series: BMJ open
ISSN: 2044-6055
ISSN-E: 2044-6055
ISSN-L: 2044-6055
Volume: 12
Issue: 7
Article number: e063572
DOI: 10.1136/bmjopen-2022-063572
Type of Publication: A1 Journal article – refereed
Field of Science: 3126 Surgery, anesthesiology, intensive care, radiology
3123 Gynaecology and paediatrics
Funding: The materials used within this study are granted by the Oulu University Hospital.
Copyright information: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: