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

Completed

• Conditions: Lymphedema; Gynecologic Cancer-related Lower Extremity Lymphedema

• Registration Number: NCT06920732
• Lead Sponsor: Zunyi Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in lower limb volume (mL) measured by circumference-based calculation	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 Outcome Measures

Name	Time	Method
Cellulitis Infection Rate (episodes/year)	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.
Change in Lymphoedema Quality of Life (LYMQOL) Score	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.
Incidence of Surgical Complications	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.
Changes in Lymphoscintigraphy and Ultrasound Findings	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).

Trial Locations

Locations (1)

Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China