Primary registry and trial identifying number	ClinicalTrials.gov identifier: NCT05064176
Date of registration in primary registry	24-8-2021
Secondary identifying numbers	Ethical Committee UZ Leuven: S63212; EudraCT: 2021-000397-29
Source of monetary and material support	Belgian Healthcare Knowledge Centre
Sponsor	University Hospitals Leuven, Clinical Trial centre, Herestraat 49, 3000 Leuven, Belgium
Contact for public and scientific queries	Nele.devoogdt@uzleuven.be
Public title	Added value of reconstructive lymphatic surgery to usual care in lymphoedema
Scientific title	Comparison of reconstructive lymphatic surgery vs no surgery, additional to decongestive lymphatic therapy (usual care), for the treatment of lymphoedema, through a multicenter, pragmatic andomized controlled trial
Acronym	SurLym-trial
Protocol version	V3.0 19-4-2022
Country of recruitment	Belgium
Health condition studied	Primary or secondary upper or lower limb lymphoedema stage 1 to 2b
Intervention	Intervention group: Reconstructive lymphatic surgery (ie, LVA or LNT or combination), added to usual care Control group: Only usual care (no surgery)
Key inclusion and exclusion criteria	-Lymphoedema: upper/ lower limb; uni-/ bilateral; primary or secondary; stage 1 to 2b; ≥ 5% vol difference or≥2 minor/ 1 major lymphoscintigraphy criterion; total score or one domain score of Lymph-ICF questionnaire≥25/100 -History of DLT (≥6M) until minimal pitting, no liposuction/ reconstructive surgery in past -In case of lower limb lymphoedema: no CVI C4-C6, no DVT/ PTS -Age≥18 years, not pregnant, BMI≤35 No allergy for ICG/ iodine; no increased activity/ benign tumour thyroid gland; no heparin use and severe renal insufficiency
Study type	Multicentre, pragmatic randomised controlled trial
Date of first enrolment	March 2022
Target sample size	180
Recruitment status	Recruiting
Primary endpoint	Lymphoedema-specific QOL, at 18 months post-baseline
Key secondary endpoints	Limb volume, at 18 months post-baseline Duration of wearing the compression garment, at 18 months post-baseline
Treatment duration	18 months (usual care)
Follow-up duration	36 months