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

Primary Purpose

Endometrial Carcinoma, Obesity, EIN

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Endometrial Carcinoma focused on measuring Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia, Endometrial Cancer Stage I, Weight Loss Surgery, Bariatric Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY

Arm Description

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.

Outcomes

Primary Outcome Measures

proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment
50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible
proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients)
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

Safety of the concurrent surgeries
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Postoperative complications
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time under anesthesia
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Total time in operating room
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Postoperative weight loss
Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Changes in lab values reflecting comorbid conditions
Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Post Operative 12-item Short Form Healthy Survey (SF-12) Survey
12-item Short Form Healthy Survey (SF-12) Survey

Full Information

First Posted
April 7, 2021
Last Updated
July 26, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04839614
Brief Title
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Official Title
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia, Endometrial Cancer Stage I
Keywords
Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia, Endometrial Cancer Stage I, Weight Loss Surgery, Bariatric Surgery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment
Description
50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible
Time Frame
2 Weeks
Title
proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients)
Description
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).
Time Frame
up 12 weeks
Secondary Outcome Measure Information:
Title
Safety of the concurrent surgeries
Description
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time Frame
3 weeks
Title
Postoperative complications
Description
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time Frame
3 weeks
Title
Time under anesthesia
Description
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time Frame
1 Day
Title
Total time in operating room
Description
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time Frame
1 Day
Title
Postoperative weight loss
Description
Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Time Frame
6 months, 1 year
Title
Changes in lab values reflecting comorbid conditions
Description
Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Time Frame
6 months, 1 year
Title
Post Operative 12-item Short Form Healthy Survey (SF-12) Survey
Description
12-item Short Form Healthy Survey (SF-12) Survey
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Feltmate, MD
Phone
617-732-8840
Email
cfeltmate@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Feltmate, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Feltmate, MD
First Name & Middle Initial & Last Name & Degree
Colleen Feltmate, MD
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Feltmate, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

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

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