The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema (LYMPH)

The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial

The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)

Study Overview

• Status: Recruiting
• Conditions: Lymphedema, Breast Cancer
• Intervention / Treatment: Procedure: Surgical Intervention; Procedure: Conservative Complex Physical Decongestion Therapy

Detailed Description

To date, conservative complex physical decongestion therapy (CDT) is the gold standard for BCRL (breast cancer related lymphedema) and includes manual lymphatic drainage, local compression with bandages and garments, physical exercises and meticulous skin care. It is, however, too often ineffective to prevent stage progression in curing BCRL and purely symptomatic. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are two surgical techniques that, in contrast to CDT, are able to actually address the underlying causes and eventually restore the lymphatic drainage. LVA achieves this by creating numerous bypasses between lymphatic vessels and venules allowing the drainage of excessive fluid within the subcutaneous tissues into the venous system, while VLNT usually brings functioning lymph nodes to an area devoid of lymph nodes or with dysfunctional lymph nodes, thus enabling the spontaneous development of new lymphatic pathways. Both techniques have shown very promising results with low complication rates and improved Quality of Life (QoL) for the patients. However, no multicentric randomized controlled trial (RCT) has yet prospectively evaluated the superiority of these surgical techniques over CDT alone, limiting patient's access to most effective treatment available. Requests for cost reimbursement must still be submitted to insurance companies in most countries and are often rejected, thus delaying surgical treatment and resulting in prolonged suffering of affected patients. This is untenable seeing as affected patients suffer from a heavy physical, psychological and financial burden. This pragmatic, randomized, multicenter trial aims to establish a solid scientific basis assessing the superiority of surgical treatment over CDT alone.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Kappos, Prof. Dr.; Phone Number: +41 61 328 62 54; Email: elisabeth.kappos@usb.ch

Study Locations

• Austria
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria
      • Not yet recruiting
      • University Clinics St.Pölten
      • Contact: Klaus Schrögendorfer; Phone Number: 0613285402; Email: lymph.trial@usb.ch
      • Contact: Christina Glisic
  • State of Vienna
    • Vienna, State of Vienna, Austria, A-1170
      • Not yet recruiting
      • Krankenhaus Göttlicher Heiland GmbH
      • Contact: Tina Deutinger, MD, PhD
      • Principal Investigator: Tina Deutinger, MD
• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • University of Ghent
    • Contact: Phillip Blondeel, Prof. Dr.; Email: Phillip.Blondeel@ugent.be
  • Jette
    • Brussels, Jette, Belgium, 1090
      • Recruiting
      • Brussels University Hospital
      • Sub-Investigator: Alexandru Nistor, MD
      • Contact: Mustapha/Alexandru Hamdi/Nistor, MD
      • Principal Investigator: Mustapha Hamdi, MD
• Brazil
  • Curitiba
    • Paraná, Curitiba, Brazil, 80730-001
      • Not yet recruiting
      • Hospital Erasto Gaertner
      • Contact: Anne Karoline Groth, Dr. med.; Phone Number: +55(41)32183300; Email: annegroth@gmail.com
• Canada
  • Montreal, Canada, QC H4A 3J1
    • Recruiting
    • McGill University, Royal Victoria Hospital
    • Contact: Josh Vorstenbosch, MD PhD FRCSC; Phone Number: +1(514)934-1934 x 35194; Email: joshua.vorstenbosch@mcgill.ca
    • Contact: Anna Towers, Dr.
  • Vancouver, Canada, BC V5Z 1M9
    • Recruiting
    • University of British Columbia, Gordon and Leslie Diamond Health Care Centre
    • Contact: Kathryn V. Isaac, Asst. Prof. Dr.; Phone Number: +1 604-336-9488; Email: kathryn.isaac@ubc.ca
• Germany
  • Bochum, Germany, 44789
    • Recruiting
    • BG Universitätsklinikum Bergmannsheil Bochum
    • Contact: Christoph Wallner, PD Dr. med., M.Sc., MHBA; Email: christoph.wallner@bergmannsheil.de
  • Düsseldorf, Germany, 40593
    • Recruiting
    • Sana Kliniken Düsseldorf
    • Contact: Katrin Seidenstücker, Dr.; Phone Number: +49 211 2800 1990; Email: katrin.seidenstuecker@sana.de
  • Erlangen, Germany, 91054
    • Recruiting
    • Uniklinikum Erlangen
    • Contact: Raymund Horch, Prof. Dr.; Email: Raymund.Horch@uk-erlangen.de
  • Essen, Germany, 45136
    • Recruiting
    • KEM Evang. Kliniken Essen-Mitte
    • Contact: Björn Behr, Prof. Dr. med.; Phone Number: +49 234 302 7152; Email: transchirurgie-zentrum@kem-med.com
    • Contact: Phone Number: +49 201 174 29006; Email: bjorn.behr@rub.de
  • Frankfurt, Germany, 60389
    • Recruiting
    • BG Klinik Frankfurt am Main
    • Contact: Christoph Hirche, Prof. Dr. med.; Phone Number: +49 69 475 23 23; Email: ulrich.kneser@bgu-ludwigshafen.de
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie
    • Contact: Steffen Eisenhardt, Prof. Dr. med.; Phone Number: +49 761 270 28170; Email: steffen.eisenhardt@uniklinik-freiburg.de
    • Contact: Email: bianca.kremer@uniklinik-freiburg.de
  • Ludwigshafen am Rhein, Germany, 67071
    • Recruiting
    • BG Klinik Ludwigshafen
    • Contact: Ulrich Kneser, Prof. Dr. med.; Phone Number: +49 621 681 023 28; Email: ulrich.kneser@bgu-ludwigshafen.de
  • Nuremberg, Germany, 90419
    • Recruiting
    • Klinikum Nürnberg
    • Contact: Denis Ehrl, MD; Email: denis.ehrl@klinikum-nuernberg.de
    • Principal Investigator: Denis Ehrl, MD
  • Regensburg, Germany, 93053
    • Recruiting
    • Caritas Krankenhaus St. Josef/ Uniklinik Regensburg
    • Contact: Lukas Prantl, Prof. Dr. med.; Phone Number: +49 941 944 6763; Email: Lukas.Prantl@klinik.uni-regensburg.de
    • Contact: Norbert Heine, Dr. med.
• Greece
  • Thessaloniki, Greece, 55133
    • Recruiting
    • Papageorgiou Hospital of Thessaloniki
    • Contact: Efterpi Demiri, Prof. Dr. med.; Phone Number: +30 231 332 38 38; Email: demirie@auth.gr
    • Contact: Dimitrios Dionysiou, Dr. med.
• Israel
  • Haifa, Israel, 3109601
    • Not yet recruiting
    • Rambam Health Clinic, ISR
    • Contact: Assaf Zeltzer; Email: a_zeltzer@rambam.health.gov.il
    • Principal Investigator: Assaf Zeltzer
• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Policlinico Universitario Fondazione Agostino Gemelli
    • Contact: Giuseppe Visconti, Dr. med.; Phone Number: +39 06 30151; Email: giuseppe.visconti@policlinicogemelli.it
  • Rome, Italy, 00133
    • Recruiting
    • Policlinico Tor Vergata: Fondazione PTV
    • Contact: Benedetto Longo, Dr. med.; Phone Number: +39 6 44291148; Email: benedetto.longo@uniroma2.it
    • Contact: Email: info@benedettolongo.com
• Netherlands
  • Maastricht, Netherlands, 6202
    • Recruiting
    • Maastricht University Medical Center
    • Contact: Shao Shan Qiu, Dr.; Phone Number: +31(0)43-3877481; Email: shanshan.qiushao@mumc.nl
• Romania
  • Cluj-Napoca, Romania, 400015
    • Recruiting
    • Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca
    • Contact: Maximilian Vlad Muntean, Dr. med.; Phone Number: +40 730085422; Email: maximilian.muntean@gmail.com
• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Gemma Pons, Dr.; Phone Number: +34 935565693; Email: GPonsP@santpau.cat
• Sweden
  • Stockholm, Sweden, 17176
    • Recruiting
    • Karolinska Institutet, K1 Molekylär medicin och kirurgi
    • Contact: Martin Halle, Dr. med.; Phone Number: +46 8 123 708 46; Email: martin.halle@ki.se
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Department of Plastic and Reconstructive Surgery Uppsala University Hospital
    • Contact: Maria Mani, Dr. med.; Email: Maria.Mani@surgsci.uu.se
• Switzerland
  • Aarau, Switzerland, 5001
    • Recruiting
    • Kantonsspital Aarau
    • Contact: Jan Plock, Prof. Dr. med.; Phone Number: +41 62 838 47 31; Email: plastischechirurgie@ksa.ch
  • Geneva, Switzerland, 1205
    • Recruiting
    • Hôpitaux Universitaires de Genève
    • Contact: Daniel Kalbermatten, Prof. Dr. med.; Phone Number: +41 22 372 80 12; Email: daniel.kalbermatten@hcuge.ch
  • Winterthur, Switzerland, 8401
    • Recruiting
    • Kantonsspital Winterthur
    • Contact: Florian Jung, Dr. med.; Phone Number: +41 52 266 24 08; Email: Florian.Jung@ksw.ch
  • Zurich, Switzerland, 8091
    • Recruiting
    • Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie
    • Contact: Nicole Lindenblatt, Prof. Dr. med.; Phone Number: +41 44 255 11 11; Email: nicole.lindenblatt@usz.ch
  • Basel
    • Basel, Basel, Switzerland, 4031
      • Recruiting
      • University Hospital Basel
      • Contact: Elisabeth Kappos, Prof. Dr.; Phone Number: +41 61 328 62 54; Email: elisabeth.kappos@usb.ch
      • Principal Investigator: Elisabeth Kappos, Prof. Dr.
  • Lausanne
    • Lausanne, Lausanne, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois
      • Contact: Pietro di Summa, PD Dr. med.; Phone Number: +41 21 314 25 25; Email: pietro.di-summa@chuv.ch
• Taiwan
  • Taiwan
    • Kaohsiung City, Taiwan, Taiwan, 833
      • Not yet recruiting
      • Kaohsiung Chang Gung Memorial Hospital
      • Contact: Johnson Chia-Shen Yang, MD
      • Principal Investigator: Johnson Chia-Shen Yang, MD
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Not yet recruiting
      • Yale School of Medicine
      • Contact: Siba Haykal, MD, PhD.
      • Principal Investigator: Siba Haykal, MD, PhD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Harvard Medical School
      • Contact: Andrea Pusic, Prof. Dr. med.; Phone Number: +16 17 732 53 61; Email: apusic@bwh.harvard.edu
      • Contact: Erin Taylor, Dr. med.
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine in St. Louis
      • Contact: Justin M. Sacks, Prof. Dr.; Phone Number: +1 314-454-4894; Email: jmsacks@wustl.edu
  • New York
    • Rochester, New York, United States, 55905
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Vahe Fahrradyan, MD
      • Principal Investigator: Vahe Fahrradyan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent.
• Patients ≥ 18 years of age.
• Former diagnosis of breast cancer.
• Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) (persisting for more than 3 months) classified as ≥ Stage 1, according to ISL.
• Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
• Ability to complete the QoL questionnaires.
• Willingness to undergo surgery.

Exclusion Criteria:

• No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
• Primary congenital Lymphedema or non-BCRL.
• Previous surgical BCRL treatment on the side intended for intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A : Surgical Group; According to the pragmatic study design, neither the diagnostic workup nor the surgery will be standardized in order to offer surgeons considerable leeway on how to perform lymphatic surgery, which resembles the flexibility in usual care. The key aspects of the preoperative workup and the surgery including the number of LVAs (Lymphovenous Anastomosis), harvesting of lymph nodes ("donor site"), time of surgery, and practical details will be registered.	Procedure: Surgical Intervention; LVA (Lymphovenous Anastomosis) and VLNT (Vascularised Lymph Node Transfer) are two advanced microsurgical techniques that are increasingly implemented in clinical practice in specialized centers and that are already carried out after health insurance application according to local standard of care. They have been studied in their respective mode of action as well as in their effectiveness in treating chronic BCRL (Breast Cancer-Related Lymphedema) in a multitude of mostly observational and single center studies with highly encouraging results. Patients in the interventional arm A will receive surgery with one of the two approaches or a combination of both, in a one or two-stage method, at the discretion of the treating surgeon. Depending on local standards one or both of the above might be combined with liposuction to the affected arm in a one or two-stage approach as well.
Active Comparator: Group B: Conservative Complex Physical Decongestion Therapy (control group); CDT (Conservative Complex Physical Decongestion Therapy) will be performed as in usual care, following the pragmatic study design. The key aspects like frequency of lymphatic drainage, time when lymphatic drainage is performed and time and class of compressive garments are used will be documented. CDT incorporates two stages of treatment. The first treatment phase (intensive phase) entails skincare, MLD (manual lymphatic drainage), exercises aimed at improvement of mobility/range of motion in the shoulder, elbow or wrist joints, and compression therapy through bandaging. Most patients undergo this phase shortly after the diagnosis of LE. CDT in the second phase (maintenance phase) aims to maintain the achieved limb volume/ circumference reduction through compression with therapeutic elastic compression garment for the arm. Skincare, mobility exercises and MLD is continued in this phase if needed	Procedure: Conservative Complex Physical Decongestion Therapy; Patients randomized to the control arm will receive CDT (Conservative Complex Physical Decongestion Therapy), which currently is considered as the best available standard of care. For this, patients will be referred to one of the dedicated LE (physical/skin) therapy clinics, if not already treated by one, according to their place of residence for continuation of standard conservative therapy. Recommendations to the procedures and treatment frequency of the conservative therapy will be made, but CDT will be done at the discretion of the treating physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Questionnaire (Lymph-ICF-UL)	The LYMPH-ICF-UL-Questionnaire (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema) is a widely used, rigorously developed, and validated patient-reported outcome (PRO) instrument for chronic breast cancer-related lymphedema. It assesses the impairments in function, activity limitations and participation restrictions of patients with upper limb lymphedema (LE). Consisting of 29 items (questions) across five different domains, each item is scored on a VAS (visual analog scale) ranging from 0 to 10. The total score on the LYMPH-ICF is equal to the sum of the item scores divided by the total number of answered items. A higher score on the Lymph-ICF indicates a greater impact on the functioning in daily life related to upper limb LE. This questionnaire helps determine if lymphatic surgery improves quality of life and patient satisfaction compared to conservative therapy.	two time assessment at baseline and 15 month after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Questionnaire (Lymph-ICF-UL)	The LYMPH-ICF-UL-Questionnaire (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema) is a widely used, rigorously developed, and validated patient-reported outcome (PRO) instrument for chronic breast cancer-related lymphedema. It assesses the impairments in function, activity limitations and participation restrictions of patients with upper limb lymphedema (LE). Consisting of 29 items (questions) across five different domains, each item is scored on a VAS (visual analog scale) ranging from 0 to 10. The total score on the LYMPH-ICF is equal to the sum of the item scores divided by the total number of answered items. A higher score on the Lymph-ICF indicates a greater impact on the functioning in daily life related to upper limb LE. This questionnaire helps determine if lymphatic surgery improves quality of life and patient satisfaction compared to conservative therapy.	13 time assessment up to 10 years after randomization
Change in Quality of Life Questionnaire (LYMPH-Q)	The Lymph-Q Upper Extremity Module is a new PROM (patient-reported outcome measure) developed to assess patient reported outcomes of BCRL in a concept-driven approach. The complete questionnaire contains 68 questions covering the patient-relevant topics Health-related quality of life (arm appearance, arm function, arm symptoms, psychological), experience of care (information), and treatment (arm sleeve). The questionnaire is used to determine whether lymphatic surgery provides better quality of life and patient satisfaction compared to conservative therapy.	15 time assessment up to 10 years after randomization
Change in Quality of Life Questionnaire (EuroQol EQ-5D-5L)	The 5-level EQ-5D version (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions (5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems) resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension can be combined into a 5-digit number that describes the patient's health state. The questionnaire is used to determine whether lymphatic surgery provides better quality of life and patient satisfaction compared to conservative therapy.	15 time assessment up to 10 years after randomization
Change in Pain score (visual analog scale)	The pain score consists of a VAS (visual analog scale) ranging from 0 (i.e. no pain) to 10 (i.e. worst pain). The VAS was published by the Yale University. It is used to determine whether lymphatic surgery provides better quality of life and patient satisfaction compared to conservative therapy.	7 time assessment up to 2 years after randomization
Assessment of (serious) adverse events	Safety is assessed via a rigorous and detailed examination of (serious) adverse events.	7 time assessment up to 2 years after randomization
Assessment of surgical complications	For the surgery group only, safety is assessed via a rigorous and detailed examination of complications of surgery. Grading is according to the modified classification of Clavien-Dindo, categorizing them into five levels ranging from minor deviations to life-threatening events. The assessment will cover both surgical stages in case of two-staged lymphedema (LE) surgery.	7 time assessment up to 2 years after randomization
Assessment of lymphangitic events (erysipelas)	The frequency of lymphangitic events (erysipelas) is closely monitored. Lymphangitic events are defined as skin infections at the lymphedema site(s) which can be treated with oral or intravenous antibiotics. The type of antibiotic given, the application form, type of hospital stay and necessity of a surgery will be assessed.	7 time assessment up to 2 years after randomization
Assessment of arm volume	Arm volume is determined by measuring the circumference of each arm at 10 cm intervals from the wrist to the axilla. The volume of each arm segment is calculated using a truncated cone model, and percentage edema volume is derived from the volume difference between the affected and unaffected arms. Both relative (relative to the unaffected arm) and absolute (volume reduction of the affected arm at the next measurement) volume change are calculated, corrected for BMI and differences between dominant and non-dominant arms.	15 time assessment up to 10 years after randomization
Assessment of the frequency of lymphatic drainage	The frequency of lymphatic drainage before the start of the study and between the study's follow-up visits is assessed.	15 time assessment up to 10 years after randomization
Assessment of the economics (for Switzerland)	To perform an economic evaluation, information regarding the condition-related medical resource use, healthcare costs, indirect costs, productivity losses, and incremental cost-effectiveness (quality-adjusted life-years) is collected. The information is based on the responses to the EQ-5D-5L questionnaire, the questions asked under burden on patients, and on other medical resource information recorded in the trial primarily for clinical purposes, at the respective visits. In addition, direct extraction of breast cancer-related lymphedema-related in- and outpatient costs, and corresponding key resource use parameters, are collected from the hospital administration systems of the participating Swiss sites, once at the 2 year follow-up visit .	9 time assessment up to 10 years after randomization
Assessment of the burden on patients	To assess the burden on patients, information regarding the total number of operative procedures, length of hospital stays, number of outpatient visits, and absence from work within two years after randomization and during the extended follow-up is collected.	9 time assessment up to 10 years after randomization

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation; Krebsforschung Schweiz, Bern, Switzerland; Rising Tide Foundation
• Investigators: Principal Investigator: Elisabeth Kappos, Prof. Dr., University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• Kappos EA, Haas Y, Schulz A, Peters F, Savanthrapadian S, Stoffel J, Katapodi MC, Mucklow R, Kaiser B, Haumer A, Etter S, Cattaneo M, Staub D, Ribi K, Shaw J, Handschin TM, Eisenhardt S, Visconti G, Franceschini G, Scardina L, Longo B, Vetter M, Zaman K, Plock JA, Scaglioni M, Gonzalez EG, Quildrian SD, Felmerer G, Mehrara BJ, Ayala JM, Pons G, Kalbermatten DF, Sacks JM, Halle M, Muntean MV, Taylor EM, Mani M, Jung FJ, di Summa PG, Demiri E, Dionyssiou D, Groth AK, Heine N, Vorstenborsch J, Isaac KV, Qiu SS, Engels PE, Serre A, Eberhardt AL, Ebner S, Schwenkglenks M, Stoel Y, Leo C, Horch RE, Blondeel P, Behr B, Kneser U, Prantl L, Boll DT, Granziera C, Hemkens L, Lindenblatt N, Haug M, Schaefer DJ, Hirche C, Pusic AL, Seidenstuecker K, Harder Y, Weber W. The LYMPH trial: comparing microsurgical with conservative treatment for chronic breast cancer-associated lymphoedema - study protocol of a pragmatic randomised international multicentre superiority trial. BMJ Open. 2025 Feb 17;15(2):e090662. doi: 10.1136/bmjopen-2024-090662.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2036

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: manual lymphatic drainage; breast cancer related lymphedema; axillary lymph node dissection; sentinel lymph node biopsy; lymphatic surgery; conservative complex physical decongestion therapy
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Lymphatic Diseases; Lymphedema; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Breast Cancer Lymphedema; Surgical Procedures, Operative
• Other Study ID Numbers: 2023-00733; mu21kappos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories following FAIR (Findability, Accessibility, Interoperability and Reuse) principles. The DKF of the University of Basel will act as an independent Data Access Committee, storing the data at time of publication on secure servers, maintained and backed-up by the IT-department of the University Hospital Basel. Researchers can request data reuse by submitting a project synopsis via dkf.unibas.ch/contact. Study results will be published in peer-reviewed journals following the Consolidated Standards of Reporting Trials (CONSORT) standards for randomized controlled trials (RCTs) and good publication practice, regardless of outcomes. Authorship for future publications will be based on contributions. An annual safety report is submitted to the local Ethics Committee by the Sponsor-Investigator according to national regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No