Compression Stockings for Lymphedema Prevention in Gynecologic Cancer Patients
NCT ID: NCT06873984
Last Updated: 2025-03-13
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-12-01
2020-12-20
Brief Summary
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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.
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Detailed Description
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This study investigates the effectiveness of compression stockings (23-32 mmHg) in reducing the incidence of postoperative lower limb lymphedema and associated symptoms in women undergoing treatment for gynecological cancers. Additionally, it evaluates the impact of compression on patients' quality of life and physical complaints up to one year postoperatively.
A total of 75 eligible women consented to participate and were preoperatively randomized (simple randomization using a random number generator) into two groups:
Compression Group (CG): Patients received individually fitted round-knit compression stockings (23-32 mmHg, RAL-GZG standard) and were instructed to wear them for approximately 9 hours per day.
No Compression Group (NCG): Patients did not receive compression therapy.
Descriptive statistics were used to summarize the collected data, including mean (x̄), standard deviation (SD), median (Me), and percentage distributions.
For sociodemographic and clinical data, comparisons between groups were performed using the chi-square test for categorical variables and the independent t-test for continuous variables.
The effects of physiotherapeutic interventions were analyzed to determine statistically significant differences between groups. To assess the normality of data distribution, the Shapiro-Wilk test was applied.
For quantitative variables related to limb volume and WAC (Water-Assisted Circumference), comparisons between two groups were conducted using the Mann-Whitney U test. Comparisons of quantitative variables across three or more groups were performed using the Kruskal-Wallis test, followed by Dunn's post-hoc test when significant differences were detected.
Correlations between quantitative variables (e.g., limb volume and WAC) were assessed using Spearman's correlation coefficient.
For repeated measurements of quantitative variables (e.g., limb volume and WAC at multiple time points), comparisons were conducted using the Friedman test, and when significant differences were found, Wilcoxon signed-rank tests with Bonferroni correction were used for post-hoc analysis.
Qualitative variables were analyzed by calculating the number and percentage of occurrences for each category. Comparisons of categorical variables between groups were performed using the chi-square test (with Yates' correction for 2x2 tables) or Fisher's exact test for small expected frequencies.
For comparisons of continuous variables across two time points, the Wilcoxon signed-rank test for paired samples was used.
A significance level of p \< 0.05 was adopted, and all p-values below this threshold were considered statistically significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Compression Group (CG)
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
compression products
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.
No Compression Group (NCG)
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).
No interventions assigned to this group
Interventions
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compression products
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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Joanna Kurpiewska-Pieniążek
OTHER
Responsible Party
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Joanna Kurpiewska-Pieniążek
Principal Investigator, PhD
Principal Investigators
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Joanna Kurpiewska-Pieniążek, PhD
Role: PRINCIPAL_INVESTIGATOR
Andrzej Frycz Modrzewski Krakow University, Krakow, Poland
Locations
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Clinical Department of Gynecology and Gynecologic Oncology, University Hospital in Krakow".
Krakow, Lesser Poland Voivodeship, Poland
Department of Gynecology and Obstetrics, including Gynecologic Oncology
Krakow, Lesser Poland Voivodeship, Poland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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
Other Identifiers
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Csplwgm-AFMKU
Identifier Type: -
Identifier Source: org_study_id
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