Secondary Lymphedema Due to Human Adjuvant Disease

NCT04588493 | Completed DMC

• 1 other identifier: HAD and lymphedema
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, descriptive, retrospective study the clinical and imaging findings of 10 lower legs of 5 patients with previous history of injection of modeling substances for cosmetic purposes at buttocks and hips ande developed lower limb edema. Lower limb lymphedema index and lymphoscintigraphy findings were evaluated and reported.

Conditions

Lymphedema, Secondary; Lymphedema of Leg; Granuloma, Foreign-Body

Keywords

human adjuvant disease

Outcome Measures

Primary Outcomes (1)

• Transport Index

  Transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points; less than 5 means a normal study, higher scores represent abnormal or pathological results

  4 months

Secondary Outcomes (1)

• Lower extremity lymphedema index

  4 months

Interventions

Lower extremity Lymphoscintigraphy DIAGNOSTIC_TEST

Study of lymphoscintigraphy (LCG) abnormalities in a group of patients with history of infiltration of modeling substances in buttocks and hips and complain about lower extremities edema. LCG was performed and evaluated by a single nuclear medicine specialist through injection of the sulfur nanocolloid Technetium 99m, injected intradermal and interdigital in bilateral toes. Dynamic studies were requested for all patients. Standardized acquisition times at 15, 30, 60 and 120 minutes after injection were taken. The following parameters were considered to obtain the transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with history of injection of modeling substances for cosmetic purposes (non Federal Drug Administration-approved substances) in buttocks and presenting lower limb edema

You may qualify if:

• Both sex
• Over 18 years old
• History of injection of modelling substances for cosmetic purposes
• History of lower limb edema

You may not qualify if:

• History of primary lower limb lymphedema
• Reject to participate
• Confirmed other causes of edema

Sponsors & Collaborators

• Hospital Angeles del Pedregal: lead

Study Sites (1)

Hospital Angeles Pedregal

Mexico City, Mexico City, 10700, Mexico

Location

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis; Granuloma, Foreign-Body

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Granuloma; Foreign-Body Reaction; Foreign Bodies; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: March 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

ME (1)