Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study

The goal of this retrospective study is to evaluate the long-term efficacy of 3L versus 2L integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (GCR-LEL). The main research question is:

Do 3L integrated techniques provide superior long-term outcomes in reducing lower extremity lymphedema compared to 2L techniques in patients with GCR-LEL?

Medical records of patients who have received either 3L or 2L integrated interventions as part of their routine clinical management for GCR-LEL were reviewed and analyzed to assess treatment outcomes over an extended follow-up period.

Study Overview

• Status: Completed
• Conditions: Lymphedema; Gynecologic Cancer-related Lower Extremity Lymphedema
• Intervention / Treatment: Procedure: VLNT（Vascularized Lymph Node Transfer）; Procedure: LVA（Lymphaticovenular Anastomosis）; Procedure: LS（Liposuction）

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Zunyi, Guizhou, China, 563003
      • Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From January 1st of 2018 to December 31th of 2023, 125 consecutive patients with secondary lower extremity lymphedema who underwent 3L(LVA+VLNT+LS) or 2L(LVA+LS or VLNT+LS) integrated surgical treatment were identified.

Description

Inclusion Criteria:

1. The patients diagnosed with gynecological cancer-related lymphedema by clinical examination are classified by the International Lymphedema Society (ISL) guidelines as Stage II to III.
2. .Aged 18-90 years.

Exclusion Criteria:

1. Lactation, for patients with pregnancy;
2. Serious heart, lung, liver, kidney disease, as well as the history of tumor patients;
3. Disease history is less than 3 months;
4. In patients with mental illness;
5. Immunodeficiency patients.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction); This triple-modality intervention combines physiologic and debulking techniques. VLNT is performed to restore lymphatic function by transferring vascularized lymph nodes to the affected limb. LVA further facilitates lymphatic drainage by creating anastomoses between lymphatic vessels and nearby venules. LS is conducted to remove excess fibroadipose tissue and reduce limb volume. This comprehensive approach is hypothesized to provide synergistic and sustained benefits in severe or refractory lymphedema cases.	Procedure: VLNT（Vascularized Lymph Node Transfer）; VLNT is a physiologic surgical procedure in which vascularized lymph nodes are harvested from a donor site (e.g., groin or submental region) and transplanted to the affected limb to restore lymphatic drainage. The transferred lymph nodes are anastomosed to recipient vessels to ensure perfusion, aiming to reconstruct lymphatic flow and reduce lymphedema-related swelling and fibrosis.; Procedure: LVA（Lymphaticovenular Anastomosis）; LVA is a supermicrosurgical technique designed to improve lymphatic drainage by creating anastomoses between functional lymphatic vessels and nearby venules. Under high magnification, lymphatic vessels (typically <0.8 mm) are identified and connected to subdermal venules to bypass obstructed lymphatic pathways, facilitating improved lymph flow and symptom relief in patients with early-stage lymphedema.; Procedure: LS（Liposuction）; LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.
VLNT + LS (Vascularized Lymph Node Transfer + Liposuction); This dual-modality intervention focuses on both physiologic restoration and volume reduction. VLNT is used to reconstruct lymphatic drainage pathways, while LS addresses tissue hypertrophy. This combination is selected for patients with poor lymphatic function and substantial limb volume increase, in whom LVA is not feasible due to lack of functional lymphatic vessels.	Procedure: VLNT（Vascularized Lymph Node Transfer）; VLNT is a physiologic surgical procedure in which vascularized lymph nodes are harvested from a donor site (e.g., groin or submental region) and transplanted to the affected limb to restore lymphatic drainage. The transferred lymph nodes are anastomosed to recipient vessels to ensure perfusion, aiming to reconstruct lymphatic flow and reduce lymphedema-related swelling and fibrosis.; Procedure: LS（Liposuction）; LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.
LVA + LS (Lymphaticovenular Anastomosis + Liposuction); This approach combines a minimally invasive physiologic procedure (LVA) with LS. LVA promotes lymph flow by bypassing obstructed lymphatic channels, while LS removes accumulated fibrofatty tissue. It is suitable for patients with partially preserved lymphatic function and moderate limb volume increase.	Procedure: LVA（Lymphaticovenular Anastomosis）; LVA is a supermicrosurgical technique designed to improve lymphatic drainage by creating anastomoses between functional lymphatic vessels and nearby venules. Under high magnification, lymphatic vessels (typically <0.8 mm) are identified and connected to subdermal venules to bypass obstructed lymphatic pathways, facilitating improved lymph flow and symptom relief in patients with early-stage lymphedema.; Procedure: LS（Liposuction）; LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower limb volume (mL) measured by circumference-based calculation	Each participant's lower limb circumference will be measured at predefined anatomical landmarks, and limb volume will be calculated using the truncated cone formula.	Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellulitis Infection Rate (episodes/year)	The incidence of cellulitis episodes per patient was assessed through retrospective chart review and clinical records. A clinically diagnosed cellulitis episode was defined by acute onset of erythema, warmth, tenderness, and edema. We compared the mean episodes per year among different surgical approach groups.	Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Change in Lymphoedema Quality of Life (LYMQOL) Score	Lymphedema-specific quality of life was measured using the LYMQOL questionnaire, which includes four domains: symptoms, emotions, function, and appearance. The total LYMQOL score was calculated and compared between preoperative and postoperative assessments in different surgical groups. We evaluated both within-group (pre-to-post) and between-group differences.	Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Incidence of Surgical Complications	Surgical complications (e.g., flap infection, necrosis, lymphorrhea, or deep vein thrombosis) were assessed through postoperative clinical evaluations and chart review. Wound healing status was recorded, and the presence of any adverse events was documented.	Up to 30 days post-surgery and during follow-up (e.g., 3, 6, 12 and 18 months)
Changes in Lymphoscintigraphy and Ultrasound Findings	Lymphoscintigraphy was performed to assess dermal backflow and collateral lymphatic vessel formation, while ultrasound evaluated lymph node and lymphatic vessels status (e.g., size, vascularity, viability). Postoperative changes were compared to baseline (preoperative) imaging in each group (LVA + VLNT + LS, VLNT + LS, LVA + LS).	Preoperative imaging vs. postoperative imaging at 6, 12 and 18 months

Collaborators and Investigators

• Sponsor: Zunyi Medical College

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: KLLY-2024-093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No