Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts
Introduction The lifetime risk of women undergoing surgery for the presence of benign ovarian pathology in the UK is 5%–10%. Despite minimally invasive surgical techniques, evidence suggests a number of healthy ovarian follicles and tissues are resected intraoperatively, resulting in subsequent decl...
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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/e060409.full |
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| author | Srdjan Saso Sadaf Ghaem-Maghami Jan Yvan Jos Verbakel Benjamin P Jones Joseph Yazbek Mona El-Bahrawy Lorraine S Kasaven |
| author_facet | Srdjan Saso Sadaf Ghaem-Maghami Jan Yvan Jos Verbakel Benjamin P Jones Joseph Yazbek Mona El-Bahrawy Lorraine S Kasaven |
| author_sort | Srdjan Saso |
| collection | DOAJ |
| description | Introduction The lifetime risk of women undergoing surgery for the presence of benign ovarian pathology in the UK is 5%–10%. Despite minimally invasive surgical techniques, evidence suggests a number of healthy ovarian follicles and tissues are resected intraoperatively, resulting in subsequent decline of ovarian reserve. As such, there is an increasing demand for the implementation of fertility preservation surgery (FPS). This study will evaluate the effect on ovarian reserve following two different surgical interventions for the management of benign ovarian cysts.Methods and analysis We will conduct a two-armed randomised controlled trial comparing laparoscopic ovarian cystectomy, considered gold standard treatment as per the Royal College of Obstetricians and Gynaecologists (RCOG) Green Top guidelines for the management of benign ovarian cysts, with ultrasound-guided laparoscopic ovarian cystectomy (UGLOC), a novel method of FPS. The study commencement date was October 2021, with a completion date aimed for October 2024. The primary outcome will be the difference in anti-Müllerian hormone (AMH) (pmol/L) and antral follicle count (AFC) measured 3 and 6 months postoperatively from the preoperative baseline. Secondary outcomes include assessment of various surgical and histopathological findings, including duration of hospital stay (days), duration of surgery (minutes), presence of intraoperative cyst rupture (yes/no), presence of ovarian tissue within the resected specimen (yes/no) and the grade of follicles excised within the specimen (grade 0–4). We aim to randomise 94 patients over 3 years to achieve power of 80% at an alpha level of 0.05.Ethics and dissemination Findings will be published in peer-reviewed journals and presented at national and international conferences and scientific meetings. The Chelsea NHS Research and Ethics Committee have awarded ethical approval of the study (21/LO/036).Trial registration number NCT05032846. |
| format | Article |
| id | doaj-art-1e9dc813426b47f7bf545dc4388f33e9 |
| 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-1e9dc813426b47f7bf545dc4388f33e92025-01-31T12:30:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-060409Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cystsSrdjan Saso0Sadaf Ghaem-Maghami1Jan Yvan Jos Verbakel2Benjamin P Jones3Joseph Yazbek4Mona El-Bahrawy5Lorraine S Kasaven62Imperial College Healthcare NHS Trust, London, UKDepartment of Gynaecology Oncology, Hammersmith Hospital, West London Gynaecological Cancer Centre, Imperial College London, London, UKNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UKDepartment of Cancer and Surgery, Imperial College London, London, UKDepartment of Cancer and Surgery, Imperial College London, London, UKDepartment of Metabolism, Digestion and Reproduction, Imperial College Healthcare NHS Trust, London, UKDepartment of Cancer and Surgery, Imperial College London, London, UKIntroduction The lifetime risk of women undergoing surgery for the presence of benign ovarian pathology in the UK is 5%–10%. Despite minimally invasive surgical techniques, evidence suggests a number of healthy ovarian follicles and tissues are resected intraoperatively, resulting in subsequent decline of ovarian reserve. As such, there is an increasing demand for the implementation of fertility preservation surgery (FPS). This study will evaluate the effect on ovarian reserve following two different surgical interventions for the management of benign ovarian cysts.Methods and analysis We will conduct a two-armed randomised controlled trial comparing laparoscopic ovarian cystectomy, considered gold standard treatment as per the Royal College of Obstetricians and Gynaecologists (RCOG) Green Top guidelines for the management of benign ovarian cysts, with ultrasound-guided laparoscopic ovarian cystectomy (UGLOC), a novel method of FPS. The study commencement date was October 2021, with a completion date aimed for October 2024. The primary outcome will be the difference in anti-Müllerian hormone (AMH) (pmol/L) and antral follicle count (AFC) measured 3 and 6 months postoperatively from the preoperative baseline. Secondary outcomes include assessment of various surgical and histopathological findings, including duration of hospital stay (days), duration of surgery (minutes), presence of intraoperative cyst rupture (yes/no), presence of ovarian tissue within the resected specimen (yes/no) and the grade of follicles excised within the specimen (grade 0–4). We aim to randomise 94 patients over 3 years to achieve power of 80% at an alpha level of 0.05.Ethics and dissemination Findings will be published in peer-reviewed journals and presented at national and international conferences and scientific meetings. The Chelsea NHS Research and Ethics Committee have awarded ethical approval of the study (21/LO/036).Trial registration number NCT05032846.https://bmjopen.bmj.com/content/12/7/e060409.full |
| spellingShingle | Srdjan Saso Sadaf Ghaem-Maghami Jan Yvan Jos Verbakel Benjamin P Jones Joseph Yazbek Mona El-Bahrawy Lorraine S Kasaven Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts BMJ Open |
| title | Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts |
| title_full | Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts |
| title_fullStr | Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts |
| title_full_unstemmed | Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts |
| title_short | Study protocol for a randomised controlled trial on the use of intraoperative ultrasound-guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts |
| title_sort | study protocol for a randomised controlled trial on the use of intraoperative ultrasound guided laparoscopic ovarian cystectomy ugloc as a method of fertility preservation in the management of benign ovarian cysts |
| url | https://bmjopen.bmj.com/content/12/7/e060409.full |
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