Compression Stockings for Lymphedema Prevention in Gynecologic Cancer Patients

NCT06873984 | Completed

• 1 other identifier: Csplwgm-AFMKU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Lymphedema

Keywords

Lower limb lympodema, compression therapy, quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Lower Limb Volume (%)

  Lower limb volume change (%) was calculated based on circumferential measurements taken every 4 cm along the limb, using the truncated cone formula. . The percentage change was calculated relative to preoperative limb volume. Unit of Measure: Percentage (%)

  Measurements were taken preoperatively and at 3, 6, and 12 months postoperatively

Secondary Outcomes (3)

• Presence of Lymphedema

  were noted before and after 3, 6 and 12 months after surgery

• Relative Edema Size (%)

  were taken before and after 3, 6 and 12 months after surgery i

• Weight-Adjusted Volume Change (WAC) (%)

  were taken before and after 3, 6 and 12 months after surgery

Other Outcomes (3)

• Physical Symptoms Related to Lower Limb Lymphedema

  Symptoms were recorded before surgery and at 3, 6, and 12 months postoperatively.

• The assessment of compression compliance

  12 months postoperatively

• Quality of Life (EORTC QLQ-C30 Score)

  Assessments were conducted at 12 months postoperatively

Study Arms (2)

Compression Group (CG)

EXPERIMENTAL

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

Other: compression products

No Compression Group (NCG)

NO INTERVENTION

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).

Interventions

compression products OTHER

Compression Group (CG): Participants received individually fitted, round-knit compression stockings with a pressure of 23-32 mmHg (Class 2, RAL-GZG standard). Compression garments were selected based on circumference measurements taken in the morning to ensure proper fit. Participants were instructed to wear the stockings for approximately 9 hours per day. The compression garments were provided by the same manufacturer (Medi GmbH \& Co., Bayreuth, Germany). Additionally, participants were advised to engage in daily physical activity (walking for at least 20 minutes per day) while wearing compression. Comprehensive education was provided on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention.

Compression Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joanna Kurpiewska-Pieniążek: lead

Study Sites (2)

Clinical Department of Gynecology and Gynecologic Oncology, University Hospital in Krakow".

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Department of Gynecology and Obstetrics, including Gynecologic Oncology

Krakow, Lesser Poland Voivodeship, 31-826, Poland

Location

Related Publications (10)

• Ochalek 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 BACKGROUND

• Stuiver 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 BACKGROUND

• Sawan 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 BACKGROUND

• Hsu 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 BACKGROUND

• Bowman 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 BACKGROUND

• Russo 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.

  PMID: 33158510 BACKGROUND

• Huang J, Yu N, Wang X, Long X. Incidence of lower limb lymphedema after vulvar cancer: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Nov;96(46):e8722. doi: 10.1097/MD.0000000000008722.

  PMID: 29145314 BACKGROUND

• Yoshihara M, Shimono R, Tsuru S, Kitamura K, Sakuda H, Oguchi H, Hirota A. Risk factors for late-onset lower limb lymphedema after gynecological cancer treatment: A multi-institutional retrospective study. Eur J Surg Oncol. 2020 Jul;46(7):1334-1338. doi: 10.1016/j.ejso.2020.01.033. Epub 2020 Jan 31.

  PMID: 32146054 BACKGROUND

• Wu X, Liu Y, Zhu D, Wang F, Ji J, Yan H. Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer. Asian J Surg. 2021 Jan;44(1):111-115. doi: 10.1016/j.asjsur.2020.03.022. Epub 2020 May 10.

  PMID: 32402630 BACKGROUND

• Hayes SC, Janda M, Ward LC, Reul-Hirche H, Steele ML, Carter J, Quinn M, Cornish B, Obermair A. Lymphedema following gynecological cancer: Results from a prospective, longitudinal cohort study on prevalence, incidence and risk factors. Gynecol Oncol. 2017 Sep;146(3):623-629. doi: 10.1016/j.ygyno.2017.06.004. Epub 2017 Jun 16.

  PMID: 28624154 BACKGROUND

Related Links

• This page provides detailed information about the EORTC QLQ-C30 questionnaire, a standardized tool used to assess the quality of life in cancer patients.
• Postoperative Effectiveness of Comprehensive Nursing Intervention for Lymphedema in Gynecological Cancer: A Controlled Study
• International Society of Lymphology

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Joanna Kurpiewska-Pieniążek, PhD

  Andrzej Frycz Modrzewski Krakow University, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: December 1, 2016
• Primary Completion: November 29, 2020
• Study Completion: December 20, 2020
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)