Bariatric Surgery Combined with Progestin Intrauterine Device for Fertility-Sparing Treatment of Early Endometrial Cancer and Atypical Hyperplasia in Women

What this Trial Is About

Young women with obesity are increasingly developing atypical hyperplasia a pre-cancer condition and endometrial cancer. Progestin therapy, such as a progestin intrauterine device pIUD, is the standard treatment for those wishing to preserve fertility, but it does not address obesity, the main driver of these conditions. This trial aims to explore whether combining bariatric surgery with pIUD therapy can improve treatment response and reduce recurrence rates compared to pIUD alone. Participants are randomly assigned to one of two groups one group will receive the standard pIUD treatment plus bariatric surgery within three months of consent, while the other group will receive the pIUD treatment alone. This pilot randomized controlled trial will assess the feasibility of a larger study by monitoring recruitment, surgery completion, and patient outcomes over several years. During the study, women will be closely monitored with imaging to ensure no spread beyond the uterus and assessed for treatment response and quality of life through patient questionnaires. Researchers will track recruitment rates, surgery completion, follow-up rates, and cancer response. The study lasts several years, with key milestones at years five and six, to gather comprehensive data on treatment feasibility and effectiveness.

Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium