Ethics and dissemination

The study was approved by the Institutional Review Board of the Obstetrics and Gynecology Hospital of Fudan University in Shanghai, China (Reference number: 2021–03; Date of approval: 18 January 2021). This study is conducted in accordance with the Declaration of Helsinki.

All patients will be given both written and oral information about the study from their gynecologist during the intake for surgery. Patients must sign an informed consent form in accordance with the Declaration of Helsinki before being included in the study. Refusal to participate will not affect standard treatment. Patients can withdraw from the study at any time during the study period. The patients or their family members can address their concerns or queries about the study related questions to the project leaders (HJ or XW) throughout the study period. The investigator has the right to withdraw a patient from the trial treatment or study in the event of secondary disease, adverse events, protocol violations, administrative reasons, or other reasons.

Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. An independent data monitoring committee (DMC) composed of a gynecologist, an epidemiologist, and a statistician is installed to oversee patients’ safety and quality of the trial. The DMC met after recruitment had started to establish a charter, and will meet at least annually. Adverse events are recorded and reported by the attending gynecologist according to the charter. The trial steering committee meets every 6 months and will be responsible for overview study progress, drafting annual reports and the final report, and submission for publication. Any modification of the trial protocol will be communicated to relevant parties by the principal investigator after agreement by the steering committee. Study results will be submitted for publication in international medical journals and on the hospital website, and presented at conferences.