A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.
BMI ≥ 35
Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT)
ECOG status <2
Evidence of myometrial invasion or extra-uterine disease on imaging
High grade or p53 endometrial cancer
History of other malignancies, except if curatively treated with no evidence of disease for > 5 years
Previous major upper abdominal surgery (ex. previous bariatric surgery, splenectomy, partial gastrectomy, liver resection, bowel resection). Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion.
Parallel
Bariatric Surgery
Procedure/SurgeryPatients who are randomized to the intervention group will receive a progestin intrauterine device and be referred for bariatric service to undergo bariatric surgery within 3 months of their study consent.
Recruitment Rate
To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved. Patients' reasons for participation or non-participation will be recorded.
Completion of Bariatric Surgery
Proportion of patients who complete bariatric surgery within 3-4 months (-2/+ 4 weeks) of randomization. A rate of \>85% will be considered feasible.
Loss to Follow-Up Rate
Loss to follow-up rate, defined as proportion of patients who do not complete 15-month assessment. A loss to follow-up rate of \<20% will be considered feasible.
Completion of Patient Reported Outcome Questionnaires
Completion rate of patient reported outcomes that will be used in the full-scale randomized controlled trial. Completion of \>80% of patient reported outcomes at baseline will indicate that use of these questionnaires is feasible.
Complete Response Rate
Overall complete response rate (CRR) after treatment with progestin intrauterine device (pIUD). This study is not powered to detect an improvement in CRR in the intervention vs. non-intervention group. However, the proportion of women who obtain a complete response in the pIUD alone group at 15 months will be used as the baseline CRR for this population and will be used to derive a sample size for a full-scale randomized controlled trial. We believe that this will be more accurate than using published data retrospective studies that are not specific to women with obesity. We will also collect the following data: (a) time to complete response, (b) overall recurrence rate, and (c) time to recurrence.
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