Evidence map›Paper›PMID 38729754›Full record

ArticleBMJ open2024

SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

Nele Devoogdt, Tessa De Vrieze, An-Kathleen Heroes, Beate Bechter-Hugl, Steffen Fieuws, Lode Godderis, Katarina Segers, Geert Maleux, Thierry Deltombe, Jacqueline Frippiat and 20 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05064176 (Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05064176 narecruitingnot on this map

Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy (Usual Care), for the Treatment of Iymphoedema, Through a Multicentre Randomised Controlled Trial

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2022 to 2026Enrolled180ConditionsLymphoedema of Leg, Lymphedema Arm, LymphedemaArmsUsual care, Reconstructive lymphatic surgery
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Nele DevoogdtDepartment of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium nele.devoogdt@kuleuven.be.ORCID 0000-0002-8117-7080
Tessa De VriezeDepartment of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium.
An-Kathleen HeroesDepartment of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium.
Beate Bechter-HuglDepartment of Vascular Surgery, Centre for Lymphedema, University Hospitals Leuven, Leuven, Belgium.
Steffen FieuwsLeuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), KU Leuven - University of Leuven, Leuven, Belgium.
Lode GodderisCentre for Environment and Health, KU Leuven - University of Leuven, Leuven, Belgium.
Katarina SegersDepartment of Plastic and Reconstructive Surgery, University Hospitals Leuven, Leuven, Belgium.
Geert MaleuxDepartment of Radiology, University Hospitals Leuven, Leuven, Belgium.
Thierry DeltombeDepartment of Physical Medicine and Rehabilitation, Centre de Reference du Lymphoedème, CHU UCL Namur - Site Godinne, Yvoir, Belgium.
Jacqueline FrippiatDepartment of Physical Medicine and Rehabilitation, Centre de Reference du Lymphoedème, CHU UCL Namur - Site Godinne, Yvoir, Belgium.
Maxime ServaesDepartment of Plastic and Reconstructive Surgery, CHU UCL Namur - Site St-Elisabeth, Namur, Belgium.
Aline BernersDepartment of Plastic and Reconstructive Surgery, CHU UCL Namur - Site St-Elisabeth, Namur, Belgium.
Philippe FosseprezDepartment of Plastic and Reconstructive Surgery, CHU UCL Namur - Site St-Elisabeth, Namur, Belgium.
Bruno KrugNuclear Medicine Department, CHU UCL Namur - Site Godinne, Yvoir, Belgium.
Francoise KayserDepartment of Radiology, CHU UCL Namur - Site Godinne, Yvoir, Belgium.
Ana FalticeanuDepartment of Radiology, CHU UCL Namur - Site Godinne, Yvoir, Belgium.
Caren RandonDepartment of Thoracic and Vascular Surgery, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Chris MontenDepartment of Radiotherapy, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Koen Van LanduytDepartment of Plastic and Reconstructive Surgery, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Bernard De PypereDepartment of Plastic and Reconstructive Surgery, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Liesl DegraeveDepartment of Plastic and Reconstructive Surgery, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Tina DecorteDepartment of Physical Medicine and Rehabilitation, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Mieke De SchryverDepartment of Physical Medicine and Rehabilitation, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Vickie Van BesienDepartment of Physical Medicine and Rehabilitation, Lymphedema Clinic, Ghent University Hospital, Ghent, Belgium.
Daniel DevosDepartment of Radiology, Ghent University Hospital, Ghent, Belgium.
Sinikka SuominenDepartment of Plastic Surgery, Helsinki University and Helsinki University Hospital, Helsinki, Finland.
Jaume Masia AyalaDepartment of Plastic Surgery, Hospital de la Santa Creu i Sant Pau and the Hospital del Mar of Barcelona, Barcelona, Spain.
Gemma PonsDepartment of Plastic Surgery, Hospital de la Santa Creu i Sant Pau and the Hospital del Mar of Barcelona, Barcelona, Spain.
Inge Fourneau *Department of Vascular Surgery, Centre for Lymphedema, University Hospitals Leuven, Leuven, Belgium.
Sarah Thomis *Department of Vascular Surgery, Centre for Lymphedema, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-8491-6264

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.

Indexed as

LymphedemaQuality of LifeBelgiumHumansLegMulticenter Studies as TopicPlastic Surgery ProceduresPragmatic Clinical Trials as TopicPlastic & reconstructive surgeryVascular medicineVASCULAR SURGERY

Identifiers

PMID38729754
PMCPMC11145716

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.