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“Tissue damage due to harvesting of the Great Saphenous Vein (GSV) for femoropopliteal bypass surgery”


- candidate number22420
- NTR NumberNTR5292
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jul-2015
- Secondary IDsMETC Atrium-Orbis-Zuyd 15-N-100
- Public Title“Tissue damage due to harvesting of the Great Saphenous Vein (GSV) for femoropopliteal bypass surgery”
- Scientific Title“Tissue damage due to harvesting of the Great Saphenous Vein (GSV) for femoropopliteal bypass surgery”
- ACRONYM
- hypothesisTo use the GSV for bypass surgery it is of the utmost importance to subtract the vein with as limited damage as possible. To harvest the GSV three techniques are generally used, namely; Standard reversed technique using additional incisions in the trajectory of the GSV, Reversed technique with a minimal invasive harvesting technique, and the in situ technique with the use of valvulotomy. We hypothesise that harvesting the GSV with the use of minimally invasive harvesting technique to be less (or equally) traumatic to the venous tissue, while retaining optimal function, when compared to the traditional techniques.
- Healt Condition(s) or Problem(s) studiedPeripheral Arterial Disease
- Inclusion criteria- Patients requiring supragenual or infragenual bypass surgery for sufficient blood supply to the distal leg.
- A circumference of >3mm of the GSV of the affected leg.
- Harvesting the GSV for bypass surgery often leaves an unused section of approximately five centimetres. This left over section is often discarded as waste. No additional harm or surgery is needed.
- Informed consent
- Exclusion criteria- GSV <3mm
- Previous intervention involving the GSV
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2015
- planned closingdate1-jan-2016
- Target number of participants18
- Interventions18 patients will be included in this study. Three separate arms with each six harvested veins are required. The veins in each separate group are harvested with one of the previously mentioned techniques. The rest over section of the harvested GSV will be used for examination under an electron microscope after immunohistochemical staining of the endothelial cells with CD-31 and CD-34. Functional tests will be performed with a myograph to test the vasomotor function of the GSV after exposure to calcium/chloride, acetylcholine and nitroprusside.
- Primary outcomeTension of GSV in millinewton (mN), contraction time in minutes, relaxation time in minutes, percentage of relaxation. Endothelial expression.
- Secondary outcome-
- Timepoints<72 hours after harvesting.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES L.J.J. Bolt
- CONTACT for SCIENTIFIC QUERIESDrs. A.G. Krasznai
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Zuyderland Medical Center, Heerlen
- Publications
- Brief summaryPatients with symptomatic PAD often require surgical interventions when experiencing ischemic rest pain, tissue loss or ulceration of the leg/foot (Rutherford 4-6). When endovascular interventions are not an option, open procedures such a bypass surgery might function as a last resort. Preferably autologous material is used for creating bypass grafts. The Greater Saphenous Vein (GSV) is the vein of first choice. To harvest the GSV three techniques are generally used, namely; Standard reversed technique using additional incisions in the trajectory of the GSV, Reversed technique with a minimal invasive harvesting technique, and the in situ technique with the use of valvulotomy. To determine the quality of the harvested vein after being subtracted by either one of three harvesting techniques. We will subject the remainder (wasted section) of the harvest veins to vasomotor tests and evaluate the quality of the endothelial tissue (after staining) using an electron microscope. We sought to determine the best possible and minimally invasive technique of subtracting the GSV while maintaining optimal function and tissue quality of the GSV to be used as a bypass graft.
- Main changes (audit trail)
- RECORD6-jul-2015 - 19-aug-2015


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