This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839614
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Colleen Feltmate, MD, Brigham and Women's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients).

Condition or disease Intervention/treatment Phase
Endometrial Carcinoma Obesity EIN Endometrial Intraepithelial Neoplasia Endometrial Cancer Stage I Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral Not Applicable

Detailed Description:

The most common risk factor for endometrial cancer is obesity. However, because early-stage endometrial cancer has a very high survival rate, patients more often suffer from long-term issues related to their weight, like heart disease, stroke, and diabetes. Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases.

This research study is a Feasibility Study. This is the first-time investigators are studying both 1) the referral process of patients with endometrial cancer to the Center for Metabolic and Bariatric Surgery without delaying curative treatment of endometrial cancer 2) the combined surgery of both hysterectomy and weight loss surgery. The combined surgery of hysterectomy and weight loss surgery has been performed both at this institution and others without increased complications, but it has not been formally studied.

Approximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY

Upon enrollment in the study at first appointment with gynecologic oncologist, referral to the BWH Center for Metabolic and Bariatric Surgery (CMBS).

  • Schedule a series of appointments with a bariatric surgeon, nutritionist and psychologist, which is part of the approval process for weight loss surgery.
  • Hysterectomy and weight loss surgery will then be scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks if you have endometrial pre-cancer.
  • Series of post-operative visits with the bariatric surgeon and gynecologic oncologic surgeon as well as the nutritionist and psychologist.
 Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
See arm description


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment [ Time Frame: 2 Weeks ]
    50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible

  2. proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients) [ Time Frame: up 12 weeks ]
    concurrent surgery will be considered feasible if 50% (7-8 patients) of patients who undergo an initial consultation at the CMBS actually undergo concurrent surgery within 8 weeks of diagnosis (or 12 weeks for EIN).


Secondary Outcome Measures :
  1. Safety of the concurrent surgeries [ Time Frame: 3 weeks ]
    compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population

  2. Postoperative complications [ Time Frame: 3 weeks ]
    compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population

  3. Time under anesthesia [ Time Frame: 1 Day ]
    compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population

  4. Total time in operating room [ Time Frame: 1 Day ]
    compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population

  5. Postoperative weight loss [ Time Frame: 6 months, 1 year ]
    Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses

  6. Changes in lab values reflecting comorbid conditions [ Time Frame: 6 months, 1 year ]
    Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses

  7. Post Operative 12-item Short Form Healthy Survey (SF-12) Survey [ Time Frame: 6 months ]
    12-item Short Form Healthy Survey (SF-12) Survey


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female adults at least 18 years of age

  • A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities

    --including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40

  • Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.

Exclusion Criteria:

  • Younger than 18 years old
  • BMI < 35
  • Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
  • Pregnant participants will be excluded from this study.

  • Patients with contraindications to bariatric surgery will also be excluded.

    --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness

  • include inability to read an English informed consent form, and unwillingness to provide informed consent.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839614


Contacts
Layout table for location contacts
Contact: Colleen Feltmate, MD 617-732-8840 cfeltmate@bwh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Colleen Feltmate, MD         
Principal Investigator: Colleen Feltmate, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Colleen Feltmate, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Layout table for investigator information
Principal Investigator: Colleen Feltmate, MD Brigham and Women's Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Colleen Feltmate, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04839614    
Obsolete Identifiers: NCT04278183
Other Study ID Numbers: 19-419
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Colleen Feltmate, MD, Brigham and Women's Hospital:
Endometrial Carcinoma
Obesity
EIN
Endometrial Intraepithelial Neoplasia
 Endometrial Cancer Stage I
Weight Loss Surgery
Bariatric Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Endometrial Neoplasms
Neoplasms
Carcinoma in Situ
Endometrial Hyperplasia
Weight Loss
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Weight
Body Weight Changes
 Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases