Secondary Lymphedema Due to Human Adjuvant Disease

NCT ID: NCT04588493

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-12-01

Brief Summary

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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

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

Conditions

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Lymphedema, Secondary Lymphedema of Leg Granuloma, Foreign-Body

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Lower extremity Lymphoscintigraphy

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Angeles del Pedregal

OTHER

Sponsor Role lead

Responsible Party

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javier lopez

Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Angeles Pedregal

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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HAD and lymphedema

Identifier Type: -

Identifier Source: org_study_id

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