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Challenges in lower limb lymphoedema assessment based on limb volume change: Lessons learnt from the SENTIX prospective multicentre study
M. Borčinová, V. Ragosch, J. Jarkovský, S. Bajsová, R. Pilka, A. Glickman, S. Garrido-Mallach, F. Raspagliesi, W. Szatkowski, M. Pakiz, LC. Snyman, R. Kocián, K. Tamussino, V. Kalist, M. Michal, MG. Segovia, R. Poka, B. Kipp, G. Szewczyk, D....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, multicentrická studie, práce podpořená grantem
- MeSH
- biopsie sentinelové lymfatické uzliny MeSH
- dolní končetina MeSH
- dospělí MeSH
- lidé MeSH
- lymfedém patologie MeSH
- nádory děložního čípku patologie MeSH
- prospektivní studie MeSH
- rozhodování * MeSH
- staging nádorů * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
- Jihoafrická republika MeSH
BACKGROUND: Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation. METHODS: In the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1-IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery. RESULTS: Patient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed. CONCLUSIONS: Given that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02494063.
Department of obstetrics and Gynecology University of Debrecen Hungary
Department of Special Operative and Oncologic Gynaecology Asklepios Clinic Hamburg Hamburg Germany
Fondazione IRCCS Instituto Nazionale Tumori Milan Italy
Gynecologic Oncology Unit La Paz University Hospital Madrid Spain
Hospital Clinico San Carlos Madrid Spain
Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic
Institute of Mother and Child Warsaw Poland
Kalafong Provincial Tertiary Hospital South Africa
Krajská nemocnice T Bati A S Zlín Czech Republic
LISOD Israeli Oncological Hospital Plyuty Ukraine
M Sklodowska Curie Memorial Institute Krakow Poland
Medical University Graz Austria
Nemocnice České Budějovice Czech Republic
Neue Freuenklinik Luzerner Kantonsspital Switzerland
Oncology Institute of East Slovakia Košice Slovakia
Citace poskytuje Crossref.org
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- $a Borčinová, Martina $u Gynecologic Oncology Centre, Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital, Central and Eastern European Gynecologic Oncology Group, CEEGOG, Prague, Czech Republic
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- $a BACKGROUND: Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation. METHODS: In the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1-IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery. RESULTS: Patient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed. CONCLUSIONS: Given that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02494063.
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