Secondary Lymphedema Due to Human Adjuvant Disease

Completed

• Conditions: Lymphedema of Leg; Granuloma, Foreign-Body; Lymphedema, Secondary

• Registration Number: NCT04588493
• Lead Sponsor: Hospital Angeles del Pedregal

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.

Detailed Description

Lymphoscintigraphy findings were reported with the Transport index (TI), were any value over 5 will represent abnormalities in lymphatic function.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-07-01
• Study Completion: 2017-12-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transport Index	4 months	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

Secondary Outcome Measures

Name	Time	Method
Lower extremity lymphedema index	4 months	For Lower extremity lymphedema (LEL) index we first added up cross-sectional areas of the extremities in 5 parts where circumferences were measured, making an approximation that the cross-sections are perfect circles. We made use of the sum of the cross-sectional area's property of being proportional to the sum of the square of the circumference to simplify the calculation of the formula. Finally, we divided the number by BMI to make corrections for the body type, and the obtained value was defined as the LEL index. Dividing the sum by BMI corrected the index according to the body type. LEL index \< 250 corresponded to LEL stage I, 250 to 300 corresponded to LEL stage II, 300 to 350 corresponded to LEL stage III, and \> 350 corresponded to LEL stage IV

Trial Locations

Locations (1)

Hospital Angeles Pedregal; 🇲🇽 Mexico City, Cdmx, Mexico