Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Obesity

Endometrial Neoplasms

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

If the patient is in group 1, she will get standard education for weight loss, which will be provided by her Gynecologic Oncologist. This will take about 15 minutes.

If the patient is in group 2, she will get standard education for weight loss provided by her Gynecologic Oncologist. Then she will be asked to view a 15-minute video to get information regarding obesity, the relationship of obesity and endometrial cancer, and the safety and benefits of bariatric surgery. These will take about 30 minutes.

Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider.

Standard weight loss education

Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider followed by a 15-minute educational video detailing the benefits of weight loss.

Standard weight loss education + Educational Video

Lead Nurse

Laura Fischer, MD

The purpose of this study is to examine whether a standardized video education tool will improve knowledge regarding obesity and bariatric surgery and increase bariatric surgery referrals for obese women with endometrial cancer.

An estimated 50% of all endometrial cancer cases are associated with obesity. Bariatric surgery has been shown to reduce the risk of hormone-related cancers, including endometrial cancer, by up to 70-80%. This prospective, study of 80 patients will be randomized to either a standard education for weight loss provided by their oncologist or a standard education plus a 15-minute video with information regarding obesity, relationship of obesity and endometrial cancer, and the safety and benefits of bariatric surgery.

This study will include women only as it is focused on a sex-specific cancer (endometrial).

Bariatric Education for Women With Obesity and Endometrial Cancer

Bariatric Surgery Among Women With Obesity and Low Risk Endometrial Cancer: A Pilot Study

Proportion of patient will complete a pre and post (6 months after enrollment) survey to examine the knowledge of obesity, endometrial cancer and bariatric surgery. These measures will be self-reported 6 months after the patient was educated on the benefits of weight loss.

Based on these pre-and post-educational surveys patient's decision to participate or to decline the bariatric surgery referral will be recorded, including the patients experience with bariatric surgery program.

University of Oklahoma

Gland and Hormone Related Diseases

Heart and Blood Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Diabetes Mellitus

Thrombosis

Embolism

Epilepsy

Migraine Disorders

Lupus Erythematosus, Systemic

Embolism and Thrombosis

Vascular Diseases

Connective Tissue Diseases

Autoimmune Diseases

Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration.

Jody Steinauer, MD

Radhika Rible, MD MS

Tabetha Harken, MD MPH

Catherine Cansino, MD MPH

Sheila Mody, MD MPH

The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.

Many women with complex medical conditions who do not desire pregnancy do not receive contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception. This is an important deficiency as many have conditions that could worsen with pregnancy or for whom pregnancy can be complicated by the medical condition. Thus it is important for women with chronic disease to only become pregnant if they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient with complex medical conditions about their contraceptive options. It summarizes the safety of specific contraceptives when used on women with medical conditions. However, little is known about the contraceptive care of these women. We do not know if the availability of the USMEC has translated into evidence-based contraceptive counseling for these women. Further, little is known about their understanding of the interaction between their disease and pregnancy, their past experience and knowledge about contraception, and their contraceptive decision-making, satisfaction and continuation.

The purpose of the Complex Contraception Registry to is to recruit a cohort of women with complex medical conditions who are seen in contraception referral practices run by family planning fellowship trained physicians. We will assess their past experiences and baseline knowledge, their post-counseling experiences and choice of contraception, and their long-term satisfaction with and continuation of contraception. A multi-center registry is necessary because individual institutions see relatively few women with rare diseases such as a history of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of participants from the 5 UC medical campuses and will oversee their follow-up for one year.

Specific Aim include (1.) To investigate what factors influence contraceptive method utilization among women with complex medical conditions and their perceived risk of unintended pregnancy (2) To investigate how women with complex medical conditions access family planning fellowship trained specialist for contraception counseling and (3.) To assess satisfaction and continuation of contraceptive methods among women with complex medical conditions.

A Complex Contraception Registry

A Complex Contraception Registry - UC Family Planning Collaborative Study

Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.

Measured with questionnaire at baseline, 3 months, and 6 months

Measured with questionnaire at 3 months and 6 months

University of California, Los Angeles

University of California, San Francisco

University of California, Irvine

University of California, Davis

University of California, San Diego

Assistant Professor

Digestive System Diseases

Ear, Nose, and Throat Diseases

Gastroesophageal Reflux

Barrett Esophagus

Esophagitis

Esophagitis, Peptic

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Precancerous Conditions

Gastroenteritis

Peptic Ulcer

Ulcer

Duodenal Diseases

Intestinal Diseases

Stomach Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Lansoprazole

Dexlansoprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months

Lansoprazole oral tablets 30 mg

The trial would to try to establish:

* The best post-operative PPI prescription protocol after Sleeve Gastrectomy
* The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)
* The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ

45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)

GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months

PPI Therapy Impact on GERD After Sleeve Gastrectomy

Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study

Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A \<8 no GERD, score A \>8 and B \> 3 GERD worsening normal life)

Mucosal damage evaluation and stratified accordingly

University of Roma La Sapienza

MD PhD

Hyperplasia

Progestins

This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.

This group will receive a progestin intrauterine device alone.

Patients 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.

Bariatric Surgery

Tara Zad

Sarah E Ferguson, MD

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.

The incidence of endometrial cancer is increasing at an alarming rate (2.6% per year). This trend parallels the rising rate of obesity, the most significant increasing risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility and thus avoid hysterectomy are treated with progestin therapy, such as progestin intra-uterine device (pIUD). However, the pIUD achieves cancer regression in only 50-70% of women, and over 50% of initial responders will develop recurrence within two years. The effectiveness of the pIUD may be improved if the driver of endometrial cancer (obesity) was simultaneously addressed. Multiple epidemiologic studies have demonstrated that bariatric surgery reduces the risk of developing endometrial cancer. Our research aims to answer the question: "Is bariatric surgery in addition to the pIUD a feasible and acceptable option for young women with endometrial cancer/atypical hyperplasia who wish to maintain their childbearing potential compared to standard treatment of pIUD alone?

This is a pilot randomized controlled trial to assess the feasibility of a full-scale randomized controlled trial. Eligible women will be identified and consented over a 21-month period, and participants will be randomized to bariatric surgery plus standard pIUD (intervention group) or to standard pIUD alone (non-intervention group) in a 1:1 fashion.

Intervention Group: Bariatric Surgery and Progestin Intrauterine Device (pIUD) Non-Intervention Group: Progestin Intrauterine Device (pIUD) alone

Participants who consent will be randomized in a 1:1 allocation.

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

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.

Proportion of patients who complete bariatric surgery within 3 months of randomization. A rate of \>85% will be considered feasible.

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 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.

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.

University Health Network, Toronto

Herbal and Botanical

Cola

Patients who were planned for surgery with Roux-en-Y gastric bypass and were operated

Patients who were planned for surgery with Sleeve Gastrectomy and were operated

Obese patients involved in a weight loss program that focuses on diet and lifestyle changes

Kristin Verbeke, PhD

The purpose of this study is to investigate the impact of bariatric surgery on the gut health. Patients operated with Roux-en-Y gastric bypass or sleeve gastrectomy and obese patients who want too loose weight with a traditional weight-loss program, will be followed up for 1 year. In these patients, the investigators will measure toxicity parameters to understand better the health status of their colon after surgery. In a next phase, the measured toxicity will be linked with certain players that might cause this toxicity. Protein metabolites, formed from undigested protein by microbiota in the colon, are expected to be toxic agents for the colon. Therefore, the investigators will investigate the fate of ingested protein once the surgery patients are metabolically stabilized.

To quantify protein assimilation after bariatric surgery, the investigators will perform in bariatric surgery patients (Roux-en- Y gastric bypass and Sleeve Gastrectomy) and in a control group a cross-sectional study with a single test day. On the test day, the study participants will consume a test meal that contains intrinsically labelled egg proteins and will take a capsule with 14C-glycocholic acid and a capsule with 3H-labelled polyethylene glycol. Participants will record a food diary 72h before and after the test day and during the test collect breath samples for 6h. Urine and stool will be collected respectively up to 24h and 72h after consumption of the test meal.

For the 1-year follow up study, the 3 patient groups (Roux-en-Y gastric bypass, Sleeve gastrectomy and control group with traditional weight loss therapy) will have 5 visits, a baseline visit and 4 visits after surgery or after starting traditional therapy. The time points after baseline include 2 weeks, 3 months, 6 months and 12 months. Each visit, a blood and stool sample will be collected, a 7-day food and stool diary will be registered and also weight loss will be recorded.

Impact of Bariatric Surgery on the Gut Environment

Impact of the Bacterial Colonial Metabolism on Fecal Water Toxicity as Biomarkers of Future Colorectal Cancer Risk After Bariatric Surgery

Faecal water toxicity : measured with a cell viability test. Toxicity : expressed as the dilution of faecal water at which 50 percent of the cells survive.

Protein digestion, malabsorption and fermentation : assessed with stable isotope technology. Digestion and malabsorption : expressed as percent of the administered isotope dose. Fermentation : expressed as percent of maximal dose of the fermentation product that can be formed.

Malabsorption of fat : calculated as ((fat intake- fat excretion)/fat intake)\*100%, expressed as coefficient of fat absorption. Excretion : measured with the Van de Kamer method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bariatric Education for Women With Obesity and Endometrial Cancer	NCT05396794	Obesity Endometrial Can... Bariatric Surge...	Standard weight... Standard weight...	18 Years - 80 Years	University of Oklahoma
A Complex Contraception Registry	NCT02219269	Diabetes Cardiovascular ... Epilepsy Migraine Neurological Di... Cancer Bariatric Surge... Organ or Tissue... Lupus Erythemat... Other Hematolog... Other Venous Em...		18 Years - 45 Years	University of California, San Diego
PPI Therapy Impact on GERD After Sleeve Gastrectomy	NCT04400136	Gastro Esophage... Barrett Esophag... Bariatric Surge...	Lansoprazole or...	18 Years - 65 Years	University of Roma La Sapienza
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium	NCT04008563	Endometrial Can... Atypical Hyperp... Bariatric Surge...	Bariatric Surge...	18 Years - 41 Years	University Health Network, Toronto
Impact of Bariatric Surgery on the Gut Environment	NCT04345328	Bariatric Surge...		18 Years - 80 Years	KU Leuven
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium	NCT04008563	Endometrial Can... Atypical Hyperp... Bariatric Surge...	Bariatric Surge...	18 Years - 41 Years	University Health Network, Toronto
PPI Therapy Impact on GERD After Sleeve Gastrectomy	NCT04400136	Gastro Esophage... Barrett Esophag... Bariatric Surge...	Lansoprazole or...	18 Years - 65 Years	University of Roma La Sapienza
A Complex Contraception Registry	NCT02219269	Diabetes Cardiovascular ... Epilepsy Migraine Neurological Di... Cancer Bariatric Surge... Organ or Tissue... Lupus Erythemat... Other Hematolog... Other Venous Em...		18 Years - 45 Years	University of California, San Diego

Spots Global Cancer Trial Database for bariatric surgery candidate