Surgical Intervention and Lymphatic Diseases.

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06067880
Collaborator
(none)
83
1
11.3
7.4

Study Details

Study Description

Brief Summary

Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage. Therefore, the use of LVA should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

Condition or Disease Intervention/Treatment Phase
  • Other: Cancer-related Unilateral
  • Other: Normal + Ectasis LVs

Detailed Description

Lymphatic-related diseases such as lymphedema often result from damage to the lymphatic system due to tumor removal and lymph node dissection surgeries, as well as tissue fibrosis caused by post-operative radiation therapy. This can lead to obstruction in the proximal channels of lymphatic flow, resulting in swelling, deformity of the distal limbs, poor wound healing, or cellulitis.

In the case of lymphatic-related diseases like lymphedema, improvement can be achieved through surgical interventions. Surgery can be categorized into physiologic reconstruction and volume reduction procedures. Among them, Supermicrosurgical Lymphaticovenous Anastomosis (LVA) is a form of physiologic reconstruction. LVA involves the separation of lymphatic vessels in the affected limb and their anastomosis with nearby small veins to alleviate limb swelling and reduce the risk of cellulitis. When using lymphaticovenous bypass surgery to treat lymphedema, the ideal scenario is to use veins for anastomosis that do not have venous blood reflux. This is because veins generally have higher blood pressure than lymphatic fluid, and if venous blood flows into the lymphatic vessels over the long term, it can reduce the patency of the lymphaticovenous anastomosis site. The choice of anastomosis technique, based on the size and position of the lymphatic vessels and veins, can also impact the post-operative outcomes. Therefore, factors such as lymphatic vessel size, flow rate, function, vein size, pressure, and the presence of reflux are closely related to the success of lymphaticovenous bypass surgery.

Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage. Therefore, the use of LVA should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

Study Design

Study Type:
Observational
Actual Enrollment :
83 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Surgical Intervention and Post Operative Improvement in Patients With Lymphatic Diseases.
Actual Study Start Date :
Sep 23, 2022
Actual Primary Completion Date :
Mar 10, 2023
Actual Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Lower Limb Lymphedema

This was a retrospective cohort propensity score-matched study. Patients with cancer-related unilateral lower limb lymphedema were enrolled.

Other: Cancer-related Unilateral
This group included patients who have used only contraction type LVs.

Other: Normal + Ectasis LVs
This group included patients who had only non- contraction type LVs.

Outcome Measures

Primary Outcome Measures

  1. Volume change after LVA. [6/12 months]

    The primary endpoint was the volume change at 6/12 months after LVA.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 1, 2015, to August 31, 2022.
Exclusion Criteria:
  • Patients under the age of 20.

  • Patients with incomplete medical records.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 83301

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT06067880
Other Study ID Numbers:
  • 202201453B0
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2023