NCT06167993

Brief Summary

Type of this study: Prospective randomized controlled study. The aim of our study is to compare patients with lymphedema who have undergone lymphovenous anastomosis surgery receiving Complex Decongestive Physiotherapy (CDP), patients with lymphedema who have not undergone surgery who receive Complex Decongestive Physiotherapy, in terms of Extremity Volume, Quality of Life and Patient Satisfaction. 26 volunteers will be included in the study as patients with lymphedema who have undergone lymphovenous anastomosis surgery and KBF (n=13), only KBF (n=13), application groups. How effective is lymphovenous anastomosis surgery and KBF or only CDP acutely in the treatment of lymhedema?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

November 20, 2023

Last Update Submit

March 3, 2024

Conditions

LymphedemaCancer

Outcome Measures

Primary Outcomes (1)

  • Tape Measure

    Extremity Volume; In calculating the circumference measurements of the lower and upper extremities, the circumference of the healthy and diseased extremities is measured at 4 cm intervals with the help of a tape measure. These circumference measurements (thickest and thinnest circumference measurement values) are then converted to volumetric measurements using the Frustum Formula.

    5 months

Secondary Outcomes (2)

  • Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL) Scale

    5 months

  • Visual Analogue Scale (VAS)

    5 months

Study Arms (2)

Group receiving CDP in patients who underwent LVA

EXPERIMENTAL

LVA: Group that underwent lymphovenous anastomosis surgery and CDP applied groups CDP:Complex Decongestive Physiotherapy

Behavioral: Complex Decongestive Physiotherapy

Group receiving CDP after lymphedema

ACTIVE COMPARATOR

Only CDP applied groups

Behavioral: Complex Decongestive Physiotherapy

Interventions

Complex Decongestive PhysiotherapyBEHAVIORAL

Complex Decongestive Physiotherapy; It consists of manual therapy, skin care, compression therapy and therapeutic exercise.

Group receiving CDP after lymphedemaGroup receiving CDP in patients who underwent LVA

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-65,
  • Having unilateral lower extremity or upper extremity lymphedema,
  • Being diagnosed with Stage 2 and 3 lymphedema,
  • Receiving lymphedema therapy for the first time,
  • Adjuvant chemotherapy for gynecological cancer,
  • Having completed radiation and surgical treatment at least 3 months and at most 5 years ago,
  • Patients with lymph vessels seen on lymphangiography,
  • Patients who have undergone LVA surgery and 1 month has passed since the surgery date
  • No evidence of disease recurrence at last follow-up visit and
  • Individuals willing to participate in the study

You may not qualify if:

  • Those who do not volunteer to participate in the study,
  • Those with bilateral lower extremity lymphedema,
  • Having upper or lower extremity edema due to systemic disease,
  • Those with active infection,
  • Patients more than 1.5 months after LVA surgery
  • Known to have mental and cognitive disorders
  • Those who were unable to communicate and cooperate were not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bilsev İnce

Konya, Turkey (Türkiye)

RECRUITING

Hanife Dogan

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

LymphedemaNeoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Hanife Dogan, Assoc.Prof.

CONTACT

+905075346142hanife_dogan@yahoo.com.tr

Bilsev İnce, Prof.

CONTACT

+905552776488bilsevince@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 13, 2023

Study Start

August 21, 2023

Primary Completion

August 21, 2023

Study Completion

June 15, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)