The use of an intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis: a feasibility study

Abstract

We aimed to evaluate the feasibility of a heart-shaped intrauterine balloon as antiadhesion method immediately after hysteroscopic adhesiolysis in terms of surgeon’s and patient’s experience. This feasibility study was performed at the Ghent University Hospital (Belgium) from 2018 to 2020. A heart-shaped intrauterine balloon was inserted in 10 women immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis. Insertion and removal of the balloon was easy in 7 women out of 10 (5-point Likert scale), and successful in all cases. The median pain score during balloon wearing on a visual analogue scale (VAS) was 1.7 (IQR 1.0–4.2). Seven out of 10 women were satisfied (5-point Likert scale). Eight out of 10 women would probably or certainly recommend the procedure to a friend (5-point Likert scale) and would use the balloon again. The heart-shaped intrauterine balloon as antiadhesion method is feasible in terms of surgeon’s and patient’s experience. Designing a proper Randomised Controlled Trial (RCT) is worth the effort. Clinical trial registration: https://clinicaltrials.gov (NCT03446755). Initial release on 27th February 2018. IMPACT STATEMENT What is already known on this subject? Intrauterine adhesion (IUA) reformation is high and different methods to prevent this subsequent to an operative hysteroscopy have been assessed. The use of antiadhesion gel, acting as a mechanical barrier, may decrease the occurrence of IUAs compared to no treatment or placebo. A heart-shaped intrauterine balloon is another example of a mechanical barrier. A small number of studies, of varying quality and with heterogeneous results, have been performed. A proper RCT, comparing the intrauterine balloon to no treatment or placebo, is needed. What the results of this study add? The heart-shaped intrauterine balloon as antiadhesion method is feasible in terms of surgeon’s and patient’s experience. What the implications are of these findings for clinical practice and/or further research? Designing a proper RCT is worth the effort.