Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA

NCT06323200 | Completed

• 1 other identifier: 202400221B0
• Study Type: observational
• Target: 189
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching.

Conditions

Lymphedema

Keywords

retrospective cohort

Outcome Measures

Primary Outcomes (1)

• Volume change after LVA.

  The primary endpoint was the volume change at 6/12 months after LVA.

  6/12 months

Study Arms (2)

Lymphedema duration > 3.6 years

Procedure: lymphaticovenous anastomosis

Lymphedema duration ≤ 3.6 years

Procedure: lymphaticovenous anastomosis

Interventions

lymphaticovenous anastomosis PROCEDURE

The patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA).

Lymphedema duration > 3.6 years; Lymphedema duration ≤ 3.6 years

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients (age \>20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from September 2015 to March 2023.

You may qualify if:

• This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 2015 to March 2023.
• Patients who underwent LVA for unilateral lower-limb lymphedema.

You may not qualify if:

• Primary lymphedema, bilateral lower limb lymphedema, history of previous LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure, and those that were lost to follow-up.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: September 1, 2015
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03