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 Faculty of Medicine and Dentistry Palacky University University Hospital Olomouc Central and Eastern European Gynecologic Oncology Group CEEGOG Olomouc Czech Republic

Department of Obstetrics and Gynecology University Hospital Ostrava Central and Eastern European Gynecologic Oncology Group CEEGOG Ostrava Poruba Czech Republic

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 Centre Department of Obstetrics and Gynaecology 1st Faculty of Medicine Charles University and General University Hospital Central and Eastern European Gynecologic Oncology Group CEEGOG Prague Czech Republic

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

The University Clinical Centre in Gdansk Poland

Unit of Gynecological Oncology Institute Clinic of Gynaecology Obstetrics and Neonatology Hospital Clinic Institut d'Investigacions Biomediques August Pi i Sunyer University of Barcelona Barcelona Spain

University medical Centre Maribor Slovenia

Citace poskytuje Crossref.org

Sentinel lymph node biopsy without systematic pelvic lymphadenectomy in females with early-stage cervical cancer: final outcome of the SENTIX prospective, single-arm, noninferiority, international trial

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ClinicalTrials.gov
NCT02494063