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Hydrophobic Tubes for Lymphedema

Primary Purpose

Lymphedema of Leg

Status
Not yet recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
implantation of hydrophobic tubes for edema fluid drainage
Best Medical Treatment
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Leg focused on measuring Lymphedema, quality of life, edema, lower limb

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculdade de Medicina da Universidade do Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Surgery + best medical treatment

Group 2: best medical treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PROMS - Lymphedema quality of life
diseae specific qol questionnaire
PROMS - SF 36
Qol questionnaire
Lymphoscintigraphy
diagnostic exam

Full Information

First Posted
July 23, 2023
Last Updated
July 23, 2023
Sponsor
Universidade do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT05970068
Brief Title
Hydrophobic Tubes for Lymphedema
Official Title
Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Lymphedema is a chronic condition that affects the lymphatic system and accumulates protein-rich fluid in the interstitial spaces of the affected limb. The condition can occur after surgery, trauma, radiation therapy, or infection and can cause significant physical, functional, and psychosocial impairment. The chronic swelling and fibrosis of the affected limb can lead to difficulty with daily activities, decreased mobility, reduced quality of life, and increased susceptibility to infections (1). Currently, the management of lymphedema involves both conservative and surgical approaches. Conservative treatment includes complex decongestive therapy, which combines manual lymphatic drainage, compression therapy, exercise, and skincare (reference here). While this approach can be effective, it requires long-term commitment and compliance from patients, which can be challenging (reference here). Surgical approaches, such as lymphaticovenular anastomosis or vascularized lymph node transfer, are reserved for patients with mild to severe or refractory lymphedema with moderate results (2). Liposuction has been used as a treatment for lower limb lymphedema. The traditional treatment of lymphedema includes compression garments, exercise, and manual lymphatic drainage, but these methods are not very effective. In advanced cases of lymphedema, where all main lymphatics vessels are obstructed, one possible solution may be to create artificial pathways for edema fluid to flow away from the obstructed regions. This can be achieved through the subcutaneous implantation of silicone tubes, a novel method for draining edema fluid in obstructive lymphedema of limbs (3). In the lower limbs, the tubes are placed from the leg to the lumbar or hypogastric region, creating channels for fluid to flow away from the obstructed areas to the non-obstructed regions, where absorption can take place. The subcutaneous implantation of hydrophobic tubes is a minimally invasive procedure that has shown promising results in the management of obstructive lymphedema of the lower limbs. In a group of 20 patients with obstructive lymphedema of the lower limbs that developed after lymphadenectomy and irradiation of the pelvis because of uterine cancer, this procedure was found to be effective after unsuccessful conservative therapy. The patients underwent the implantation of hydrophobic silicone tubes, followed by external compression using intermittent pneumatic compression and elastic support of tissues (3). Overall, the implantation of hydrophobic tubes presents a promising alternative for managing obstructive lymphedema of the lower limbs. It has the potential to improve the quality of life for those who suffer from this condition, especially in advanced cases where other treatment options have failed. Further research is necessary to validate the efficacy of this approach and its long-term outcomes as well as to develop new bioengineered tubes for the drainage of lymphedematous extremities. Vaillant L, Tauveron V. [Primary lymphedema of limbs]. Presse Med. 2010;39(12):1279-86. Lee JW, Lee TY, Moon KC, You HJ, Kim DW. Lymphatic complex transfer as combined lymph vessel and node transfer for advanced stage upper extremity lymphedema. J Vasc Surg Venous Lymphat Disord. 2023. 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;3(4):401-8. Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, et al. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021;21(1):188. Nuri T, Iwanaga H, Otsuki Y, Ueda K. Lymphoscintigraphy for prediction of effect of lymphaticovenular anastomosis for treatment of secondary lower limb lymphedema. J Vasc Surg Venous Lymphat Disord. 2022;10(5):1079-86 e2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Leg
Keywords
Lymphedema, quality of life, edema, lower limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Surgery + best medical treatment
Arm Type
Experimental
Arm Description
The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available.
Arm Title
Group 2: best medical treatment
Arm Type
Active Comparator
Arm Description
This control group would receive only the best medical treatment available.
Intervention Type
Procedure
Intervention Name(s)
implantation of hydrophobic tubes for edema fluid drainage
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Best Medical Treatment
Intervention Description
Compressive therapy, Phisioterapy, venous intervention
Primary Outcome Measure Information:
Title
Lower limb circumference in cm
Description
Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee
Time Frame
Preoperative, six months, one year, second year
Secondary Outcome Measure Information:
Title
PROMS - Lymphedema quality of life
Description
diseae specific qol questionnaire
Time Frame
preoperative, six months, one year, two years
Title
PROMS - SF 36
Description
Qol questionnaire
Time Frame
preoperative, six months, one year, two years
Title
Lymphoscintigraphy
Description
diagnostic exam
Time Frame
preoperative, one year (only in the intervention group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Secondary lymphedema Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes) Acute infection of the limb Chronic venous insufficiency Neoplasic disease
Facility Information:
Facility Name
Faculdade de Medicina da Universidade do Porto
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only principal Investigators
Citations:
PubMed Identifier
26992618
Citation
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.
Results Reference
background
PubMed Identifier
34879819
Citation
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.
Results Reference
background

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Hydrophobic Tubes for Lymphedema

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