An observational study in Obesity, Morbid, Postmenopause and Endometrial Thickening, sponsored by Kasr El Aini Hospital. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Kasr El Aini Hospital · Observational
Obesity changes how the body produces and processes estrogen. After menopause, higher estrogen exposure is linked to thickening of the lining of the womb (endometrium) and a higher risk of endometrial cancer. Bariatric (weight-loss) surgery produces large and lasting weight loss, but how it changes estradiol levels and the endometrium in postmenopausal women is not well described.
This prospective cohort study will follow 78 postmenopausal women with obesity who are eligible for bariatric surgery at Cairo University hospitals: 39 women who undergo bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass) as part of their routine care, and 39 matched women who choose non-surgical medical and lifestyle management. Serum estradiol and endometrial thickness (measured by transvaginal ultrasound) will be measured at baseline and again 6 and 12 months later. The study will compare these changes between the two groups and examine whether changes in estradiol are associated with changes in endometrial thickness and with weight loss.
Background:
Obesity is associated with hormonal, metabolic and reproductive abnormalities that may influence endometrial proliferation. Increased adipose tissue is associated with altered estrogen metabolism, insulin resistance and other metabolic disturbances that may contribute to an increased risk of endometrial hyperplasia and endometrial cancer. Bariatric surgery is an established treatment for severe obesity and improves several metabolic and reproductive abnormalities, and published evidence suggests that it may alter reproductive hormone profiles and is associated with a lower long-term risk of obesity-related endometrial cancer. Transvaginal ultrasound is a non-invasive method for measuring endometrial thickness. In this study, endometrial thickness is used as a measurable marker of endometrial change, not as a screening test for endometrial cancer.
Objective:
To prospectively assess the effect of bariatric surgery on endometrial thickness and serum estradiol level in postmenopausal women with obesity, and to study the association between changes in serum estradiol and changes in endometrial thickness.
Design:
Prospective comparative cohort study at Cairo University hospitals (Kasr Al Ainy). Postmenopausal women presenting to the General Surgery and Gynaecology outpatient clinics are screened against the eligibility criteria and allocated to one of two parallel groups according to their planned clinical management:
Baseline assessment (before surgery or before starting non-surgical management):
Follow-up:
Both groups are reassessed at 6 and 12 months after baseline (after surgery in the surgical group) with the same protocol: weight, BMI and percentage of excess weight loss; serum estradiol; transvaginal endometrial thickness using the same technique; and documentation of any significant clinical events or complications.
Sample size:
Calculated with the ClinCalc sample size calculator for cohort studies (alpha 0.05, power 80%) from published serum estradiol values in women with obesity before and after bariatric surgery: 78 women in total (39 per group). Participants are enrolled by convenience sampling, with each surgical participant matched to a non-surgical control.
Statistical analysis:
SPSS version 25. Qualitative data are presented as number and percentage, and quantitative data as mean and standard deviation or median and interquartile range. Groups are compared with the chi-square or Fisher exact test for categorical data and the Student t test or paired t test for parametric data, with non-parametric equivalents where appropriate. Correlations are assessed with Pearson or Spearman coefficients as appropriate. A p value of 0.05 or less is considered significant.
Funding: Faculty of Medicine, Cairo University.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 78 is close to the median of 80 across 311 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Postmenopausal women with obesity who meet the eligibility criteria for bariatric surgery, recruited from the General Surgery and Gynaecology outpatient clinics of Cairo University hospitals (Kasr Al Ainy). Women scheduled for bariatric surgery form the surgical cohort; women who meet the same criteria but choose non-surgical medical or lifestyle management form the comparison cohort, matched by age (within 5 years) and BMI class.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal women with obesity scheduled for elective bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass) as part of routine care at Cairo University hospitals. Serum estradiol and transvaginal endometrial thickness are measured before surgery and 6 and 12 months after surgery. Planned n = 39.
Procedure: Bariatric surgery
Postmenopausal women with obesity who meet the same eligibility criteria for bariatric surgery but choose conventional non-surgical medical or lifestyle management, matched to the surgical group by baseline age (within 5 years) and BMI class. Serum estradiol and transvaginal endometrial thickness are measured at baseline and 6 and 12 months later. Planned n = 39.
Behavioral: Conventional non-surgical obesity management
Elective sleeve gastrectomy, Roux-en-Y gastric bypass or one-anastomosis gastric bypass performed as part of routine clinical care. The procedure is chosen by the primary surgical team; the study protocol does not determine or influence the choice. The procedure performed is documented.
Also known as: Metabolic and bariatric surgery
Routine conservative medical management of obesity consisting of standard dietary counselling and structured lifestyle modification supervised by the participant's primary care physician, without surgery.
Change in serum estradiol level from baseline to 12 months, compared between the surgical and non-surgical groups
Serum estradiol (pg/mL) measured in a venous blood sample drawn under standardized conditions at baseline (before surgery in the surgical group, before starting non-surgical management in the comparison group) and at 12 months. The absolute change (12 months minus baseline) is compared between the bariatric surgery group and the non-surgical group.
Time frame: Baseline and 12 months
Change in endometrial thickness from baseline to 12 months, compared between the surgical and non-surgical groups
Endometrial thickness (mm) measured by transvaginal ultrasound in the sagittal plane at the point of maximum thickness, using the same standardized technique at each visit. The absolute change (12 months minus baseline) is compared between the bariatric surgery group and the non-surgical group.
Time frame: Baseline and 12 months
Correlation between the change in serum estradiol level and the change in endometrial thickness
Correlation coefficient (Pearson or Spearman, as appropriate) between the 12-month change in serum estradiol (pg/mL) and the 12-month change in transvaginal endometrial thickness (mm) across both study groups.
Time frame: Baseline to 12 months
Percentage of excess weight loss (%EWL)
Weight lost since baseline divided by baseline excess weight, multiplied by 100, recorded at 6 and 12 months in both groups.
Time frame: 6 and 12 months
Correlation between change in BMI and serum estradiol level
Correlation coefficient (Pearson or Spearman, as appropriate) between the change in BMI (kg/m²) from baseline and serum estradiol (pg/mL) at 6 and 12 months, across both groups.
Time frame: 6 and 12 months
Correlation between change in BMI and endometrial thickness
Correlation coefficient (Pearson or Spearman, as appropriate) between the change in BMI (kg/m²) from baseline and transvaginal endometrial thickness (mm) at 6 and 12 months, across both groups.
Time frame: 6 and 12 months
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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