Clinical trial · Interventional
Compression Stockings for Lymphedema Prevention in Gynecologic Cancer Patients
Compression Stockings for Preventing Lower Limb Lymphedema in Women Treated for Gynecological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial was to evaluate whether compression stockings (23-32 mmHg) reduce the incidence of postoperative lymphedema and accompanying symptoms, as well as to assess the comfort of using compression in women undergoing treatment for gynecological malignancies up to one year after surgery. The main objectives were to determine: Whether compression stockings applied immediately after radical surgery, in combination with physical activity, reduce the risk of developing lymphedema. Whether the use of compression stockings affects the quality of life. Whether compression stockings influence specific physical complaints related to the lower limbs. Patients were assessed preoperatively and at 3, 6, and 12 months postoperatively. Limb circumferences were measured at predefined anatomical points to calculate limb volume changes over time. Additionally, subjective symptoms, quality of life, and adherence to compression therapy were evaluated. Researchers compared a group using compression stockings with a control group without compression to analyze potential benefits and complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| compression products | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Compression Group (CG)
- description
- Experimental: Compression Group (CG) Women in the CG group were provided with individually fitted round-knit compression stockings with a pressure of 23-32 mmHg (class 2, RAL-GZG standard classification). They received detailed instructions on usage, recommending approximately 9 hours of wear per day. The compression garments were selected based on circumference measurements taken in the morning and were sourced from the same manufacturer (Medi GmbH \& Co., Bayreuth, Germany). In addition, physical activity (PA) was encouraged, specifically walking for 20 minutes daily, with compression stockings worn during the activity. All participants received comprehensive education on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention. Proper skin hygiene was maintained through daily washing with hypoallergenic soap, thorough drying (especially between the toes and fingers), and regular skin moisturizing. A simplified version of manual lymph drainage wa
- interventionNames
- Other: compression products
- type
- NO_INTERVENTION
- label
- No Compression Group (NCG)
- description
- Women in the NCG group did not receive compression therapy. However, they were encouraged to : Physical activity (PA) was recommended, specifically walking for 20 minutes every day. All women received comprehensive education on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention. Proper skin hygiene was maintained through daily washing with hypoallergenic soap, thorough drying (especially between the fingers), and regular skin moisturizing. A simplified version of manual lymph drainage aimed at improving lymphatic flow was recommended for 20 minutes per day. The technique included the unaffected areas of the body (neck, chest, and abdomen).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Women who underwent radical surgery for vulvar cancer. Women who underwent radical surgery for cervical, uterine, or ovarian cancer, with systemic pelvic lymph node dissection. Overweight or obese patients (BMI \> 25.0 kg/m²) treated for uterine or ovarian cancer, regardless of whether systemic pelvic lymph node dissection was performed. Women over 18 years of age. Exclusion Criteria: Women with a history of lymphedema, venous edema, an ECOG score \> 2, congestive heart failure, renal failure, hypothyroidism, leg ulcers, or severe lower limb ischemia (Fontaine class ≥ 2), as well as those with metastases, relapse, or other malignancies treated within five years prior to study entry, were excluded.
References
Publications (10)
- BACKGROUNDOchalek K, Gradalski T, Partsch H. Preventing Early Postoperative Arm Swelling and Lymphedema Manifestation by Compression Sleeves After Axillary Lymph Node Interventions in Breast Cancer Patients: A Randomized Controlled Trial. J Pain Symptom Manage. 2017 Sep;54(3):346-354. doi: 10.1016/j.jpainsymman.2017.04.014. Epub 2017 Aug 8. PMID 28797867
- BACKGROUNDStuiver MM, de Rooij JD, Lucas C, Nieweg OE, Horenblas S, van Geel AN, van Beurden M, Aaronson NK. No evidence of benefit from class-II compression stockings in the prevention of lower-limb lymphedema after inguinal lymph node dissection: results of a randomized controlled trial. Lymphology. 2013 Sep;46(3):120-31. PMID 24645535
- BACKGROUNDSawan S, Mugnai R, Lopes Ade B, Hughes A, Edmondson RJ. Lower-limb lymphedema and vulval cancer: feasibility of prophylactic compression garments and validation of leg volume measurement. Int J Gynecol Cancer. 2009 Dec;19(9):1649-54. doi: 10.1111/IGC.0b013e3181a8446a. PMID 19955953
- BACKGROUNDHsu YY, Liu CY, Ho CL, Hsu KF. Determinants of quality of life related to lower limb lymphedema in women with gynecological cancer surgery. Asia Pac J Oncol Nurs. 2022 Oct 3;10(1):100153. doi: 10.1016/j.apjon.2022.100153. eCollection 2023 Jan. PMID 36406465
- BACKGROUNDBowman C, Piedalue KA, Baydoun M, Carlson LE. The Quality of Life and Psychosocial Implications of Cancer-Related Lower-Extremity Lymphedema: A Systematic Review of the Literature. J Clin Med. 2020 Oct 2;9(10):3200. doi: 10.3390/jcm9103200. PMID 33023211
- BACKGROUNDRusso S, Walker JL, Carlson JW, Carter J, Ward LC, Covens A, Tanner EJ 3rd, Armer JM, Ridner S, Hayes S, Taghian AG, Brunelle C, Lopez-Acevedo M, Davidson BA, Schaverien MV, Ghamande SA, Bernas M, Cheville AL, Yost KJ, Schmitz K, Coyle B, Zucker J, Enserro D, Pugh S, Paskett ED, Ford L, McCaskill-Stevens W. Standardization of lower extremity quantitative lymphedema measurements and associated patient-reported outcomes in gynecologic cancers. Gynecol Oncol. 2021 Feb;160(2):625-632. doi: 10.1016/j.ygyno.2020.10.026. Epub 2020 Nov 4.