Management of benign ovarian cysts: Randomised Controlled Trial
Research type
Research Study
Full title
Intra-operative ultrasound guided laparoscopic ovarian cystectomy (UGLOC) in the management of benign ovarian cysts: Randomised Controlled Trial
IRAS ID
290747
Contact name
Joseph Yazbek
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Title: Intra-operative ultrasound guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts.
Background:
Approximately 10% of women in the UK will undergo surgery for the presence of an ovarian mass during their lifetime. Ovarian surgery, however, is not without risks and can potentially harm healthy ovarian tissue surrounding the cyst, resulting in reduced reproductive potential (the ability of the ovary to produce eggs for fertilisation). Surgical methods to preserve healthy ovarian tissue and improve the chances of successful pregnancy post-operatively are known as Fertility Preserving Surgery (FPS). Evidence suggests that a novel approach of FPS involving the removal of an ovarian cyst performed under ultrasound guidance improves the differentiation between the healthy ovarian tissue and the ovarian cyst. As such, the surgeon can remove the cyst alone, whilst limiting disruption to the healthy surrounding ovarian tissue.Aim: The purpose of this study is to assess if surgical removal of an ovarian cyst performed under ultrasound guidance improves the reproductive potential of the ovaries, when compared to surgery performed without ultrasound guidance.
Eligibility: All patients of reproductive age (18-45 years old) with ultrasound features suggestive of a benign ovarian cyst requiring surgical treatment (removal of the cyst). Patients diagnosed with benign ovarian cysts, deemed to be non -harmful to the patient if left untreated, of the following classifications can be included in the study: dermoid, simple cyst, serous cystadenoma, mucinous cystadenoma or endometrioma.
Design: A multicentre randomised controlled trial. Women across Imperial College London Healthcare and University College London Trusts will be allocated to a surgical treatment group at random: 1) laparoscopic ovarian cystectomy performed without ultrasound guidance (control group) or 2) ultrasound guided laparoscopic ovarian cystectomy performed with ultrasound guidance (fertility preservation surgery: intervention group).
Duration: 3 years
REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0366
Date of REC Opinion
13 Aug 2021
REC opinion
Further Information Favourable Opinion