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NCT Number: NCT06920732

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.

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Key information

Conditions

Gynecologic Cancer-related Lower Extremity Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • .Aged 18-90 years.

Exclusion criteria

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

Treatment and study plan

VLNT（Vascularized Lymph Node Transfer）

Procedure

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.

LVA（Lymphaticovenular Anastomosis）

Procedure

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.

LS（Liposuction）

Procedure

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.

Primary outcomes

  1. Change in lower limb volume (mL) measured by circumference-based calculation

    Time frame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)

    Each participant's lower limb circumference will be measured at predefined anatomical landmarks, and limb volume will be calculated using the truncated cone formula.

Secondary outcomes

  1. Cellulitis Infection Rate (episodes/year)

    Time frame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)

    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.

  2. Change in Lymphoedema Quality of Life (LYMQOL) Score

    Time frame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)

    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.

  3. Incidence of Surgical Complications

    Time frame: Up to 30 days post-surgery and during follow-up (e.g., 3, 6, 12 and 18 months)

    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.

  4. Changes in Lymphoscintigraphy and Ultrasound Findings

    Time frame: Preoperative imaging vs. postoperative imaging at 6, 12 and 18 months

    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).

Sponsors and collaborators

Lead sponsor

Zunyi Medical College

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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