Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema

NCT05970068 | Not Yet Recruiting

• 1 other identifier: 300-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.

Conditions

Lymphedema of Leg

Keywords

Lymphedema; quality of life; edema; lower limb

Outcome Measures

Primary Outcomes (1)

• Lower limb circumference in cm

  Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee

  Preoperative, six months, one year, second year

Secondary Outcomes (3)

• PROMS - Lymphedema quality of life

  preoperative, six months, one year, two years

• PROMS - SF 36

  preoperative, six months, one year, two years

• Lymphoscintigraphy

  preoperative, one year (only in the intervention group)

Study Arms (2)

Group 1: Surgery + best medical treatment

EXPERIMENTAL

The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available.

Procedure: implantation of hydrophobic tubes for edema fluid drainage; Device: Best Medical Treatment

Group 2: best medical treatment

ACTIVE COMPARATOR

This control group would receive only the best medical treatment available.

Device: Best Medical Treatment

Interventions

implantation of hydrophobic tubes for edema fluid drainage PROCEDURE

1 - A 2-cm-long incision is made at the border of the hypogastrium or lumbar region 10 cm above the inguinal crease; 2- A 1.5-cm-wide and 100-cm-long metal tube tunneling device is introduced under the skin and bluntly passed in the subcutaneous tissue toward the thigh and internal aspect of the calf; 3- Incisions 2 cm long are made in the groin and calf, through which the tunneling device was passed; 4-The hydrophobic tube is passed upward through the tunneling device, after which the tunneling device is removed; 5-The upper and lower ends of the hydrophobic tubes are fixed to the fascia with absorbable sutures.

Group 1: Surgery + best medical treatment

Best Medical Treatment DEVICE

Compressive therapy, Phisioterapy, venous intervention

Group 1: Surgery + best medical treatment; Group 2: best medical treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower limb lymphedema (Grade II-IV)
• Total occlusion at lymphoscintigraphy
• Patients treated at Centro Hospitalar Universitário de São João by the same surgical team
• Age \>18 years old;
• Lymphedema praecox
• Lower limb perimeter \>15% superior to contralateral limb

You may not qualify if:

• Secondary lymphedema
• Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)
• Acute infection of the limb
• Chronic venous insufficiency
• Neoplasic disease

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculdade de Medicina da Universidade do Porto

Porto, 4200-319, Portugal

Location

Related Publications (2)

• Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):401-408. doi: 10.1016/j.jvsv.2015.05.001. Epub 2015 Jun 30.

  PMID: 26992618 BACKGROUND

• Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, Choi JY. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021 Dec 8;21(1):188. doi: 10.1186/s12880-021-00713-1.

  PMID: 34879819 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Edema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, PHD, FEBVS

Model Details: Once eligible patients have been identified, they would be randomized into one of two groups - the intervention group or the control group. Randomization will help ensure that the two groups are comparable in terms of baseline characteristics, which can minimize the risk of bias in the study. The program used will be https://www.random.org/lists/. Group 1: Surgery + best medical treatment The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage, in addition to the best medical treatment available. Group 2: best medical treatment This control group would receive only the best medical treatment available.

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 1, 2023
• Study Start: December 15, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)