Morbidity of Conventional and No-touch Saphenectomy in Coronary Artery Bypass Grafting.
52 patients around the world
Available in Uruguay
Current clinical trials have shown that the no-touch saphenectomy technique has had a
positive impact on the short- and long-term patency of coronary bypass, compared to the
conventional extraction technique. It is important to highlight that the conventional
technique is the most used in our country (Uruguay, South America), while the "no touch"
has fallen into disuse.
Given this disparity in the application of the techniques, it is considered essential to
compare both methods in terms of morbidity. For this purpose, a prospective randomized
clinical trial will be carried out.
The primary objective is to demonstrate the non-inferiority of the "no touch" technique
over the conventional technique in terms of wound morbidity in patients undergoing
coronary revascularization, within a non-inferiority margin. Defining morbidity as the
combined result of local infection, hematoma, blisters, secretions, necrosis, wound
dehiscence, paresthesias, pain and functional impotence.
The investigators will seek to achieve as a specific objective the incidence of each of
the study factors: local infection, hematoma, blisters, secretions, necrosis, wound
dehiscence, paresthesias, pain, functional impotence and then compare them between both
groups at different times.
The anatomopathological study of some of the saphenous vein preparations, one "no touch"
and the other conventional, will also be carried out using optical microscopy and
ultrastructural comparisons using transmission electron microscopy.
Additionally, patients will be offered computed tomography angiography every year to
evaluate graft patency.
There are not many relevant randomized clinical trials that compare the morbidity of this
technique with the conventional one. In this context, we consider it crucial to evaluate
whether there are significant differences in terms of wound morbidity in the
mid-postoperative period (1 week), late (1 month) and long-term postoperative period (6
months).
We will define each variable previously: it will be considered to have a local infection
when the wound shows signs of flow and it has been necessary to start antibiotic
treatment, hematoma when there is a tumor or abnormal hardening caused by the
accumulation of blood, flictenes when a skin blister appears on the wound that contains
watery substances and not pus, secretions when the wound secretes a liquid (serous,
bloody, purulent), necrosis when there is a necrotic plaque in the wound larger than 10 x
10 mm, dehiscence of the wound when the suture loses continuity, paresthesia when there
is a tingling sensation due to an irritative sensitivity disorder, pain when it is
located at the level of the wound and functional impotence when it prevents or limits
ambulation.
Through multivariate analysis, the relationship with independent factors will be
analyzed.
Null hypothesis: "no touch" saphenectomy is inferior to the conventional technique.
Alternative hypothesis: "no touch" saphenectomy is not inferior to the conventional
technique.
Existing studies have focused their attention on evaluating the patency of the ducts;
however, there is a lack of solid information on the morbidity associated with this
technique in the lower limb of patients. Currently, the most widely used technique
remains the conventional one, which involves a continuous incision in the skin of the leg
or thigh. In this technique, a dissection of the subcutaneous tissue surrounding the vein
is performed, the collaterals are ligated, and the free venous duct is sectioned. The
length of the conduit varies depending on the amount of bypass to be performed. During
the extraction of the saphenous vein using the "no touch" technique, it is sectioned with
the perivascular adipose tissue and the saphenous nerve of the leg, therefore, it is of
great interest for us to evaluate the incidence of the postoperative complications,
previously mentioned, and compare these results with those obtained through the
conventional technique.
Instituto Nacional de Cirugia Cardiaca, Uruguay
1Research sites
52Patients around the world
This study is for people with
Cardiovascular disease
Coronary heart disease
Requirements for the patient
To 70 Years
All Gender
Medical requirements
Patients undergoing coordination coronary revascularization surgery, in which it is necessary to use the internal saphenous vein as a conduit.
Emergency surgeries.
Poor metabolic control (HbA1c > 6.5%).
Chronic venous insufficiency or chronic obstructive arteriopathy of the lower limbs.
Type II obesity (BMI>35).
Sites
Instituto Nacional de Cirugía Cardíaca
Recruiting
Prof. Dr. Pablo Purriel, 11600 Montevideo, Departamento de Montevideo, Uruguay
StudyTNT
SponsorInstituto Nacional de Cirugia Cardiaca, Uruguay