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NCT05992909 Clinical Trial

Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study

Lymphadenectomy Clinical Trial

Official title:
Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05992909
Other study ID # 2023-0203
Secondary ID NCI-2023-06282
Status Recruiting
Phase
First received
Last updated
Start date August 2, 2023
Est. completion date August 1, 2027

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Ashleigh Francis, MD
Phone 713-563-4598
Email amfrancis@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

Description:

Primary Objectives: The objective of this study is to evaluate the protective benefit to performing LVB surgery at the time of ILND. In the secondary objective, we will compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date August 1, 2027
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Eligibility Criteria: 1. Patients greater than or equal to 18 years of age. 2. Patients willing to participate. 3. Patients able to complete informed consent. 4. Patients undergoing ILND. Exclusion Criteria: 1. Patients taking anticoagulants within 7 days prior to surgery. 2. Patients that are known to be pregnant at the time of surgery. 3. Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period. 4. Patients with BMI greater than 50.0.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lymphovenous bypass procedure
Participants will return to the clinic 14 days, 6 months, 12 months, 18 months, and 24 months after your surgery for measurements of your legs to see if there are changes over time

Locations
Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03 through study completion; an average of 1 year
See also
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Recruiting NCT06329102 - Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen
Completed NCT02115477 - Lymphedema After Primary Surgery for Endometrial Cancer
Not yet recruiting NCT03877627 - The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma N/A

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