Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Below-knee amputation for ischaemic gangrene. Prospective, randomized comparison of a transverse and a sagittal operative technique. One-stage versus two-stage amputation for wet gangrene of the lower extremity: a randomized study.
The treatment of rest pain, ulceration, and gangrene of the leg (severe limb ischaemia) remains controversial. We instigated the BASIL trial to compare the outcome of bypass surgery and balloon angioplasty in such patients.
                We randomly assigned 452 patients, who presented to 27 UK hospitals with severe limb ischaemia due to infra-inguinal disease, to receive a surgery-first (n=228) or an angioplasty-first (n=224) strategy. The primary endpoint was amputation (of trial leg) free survival. Analysis was by intention to treat. The BASIL trial is registered with the National Research Register (NRR) and as an International Standard Randomised Controlled Trial, number ISRCTN45398889.
                The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint (amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation (three assigned angioplasty, two surgery); of these, three were lost (one angioplasty, two surgery) during the first year of follow-up. 195 (86%) of 228 patients assigned to bypass surgery and 216 (96%) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median (IQR) of 6 (3-16) and 6 (2-20) days after randomisation, respectively. At the end of follow-up, 248 (55%) patients were alive without amputation (of trial leg), 38 (8%) alive with amputation, 36 (8%) dead after amputation, and 130 (29%) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival (48 vs 60 patients; unadjusted hazard ratio 1.07, 95% CI 0.72-1.6; adjusted hazard ratio 0.73, 0.49-1.07). We saw no difference in health-related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy.
                In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and a balloon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival, and in the short-term, surgery is more expensive than angioplasty. In a prospective, randomized study a comparison was made of the results of primary below-knee amputation for ischaemic gangrene carried out by two methods: In 47 cases by the transverse technique with a long posterior musculo-cutaneous flap and in 41 cases by the sagittal technique using equally large medial and lateral musculo-cutaneous flaps--in both instances followed by 2 weeks in a half-open plaster cast with extended knee. The sex ratio and age distribution were the same in both groups. Minor differences in the vascular condition between the groups, assessed by the duration of rest pain, pulsation findings, extent of gangrene, and frequency of diabetes, wholly or partially equalized each other. The course of healing was the same in both groups, primary healing being attained in 38 per cent and 41 per cent, respectively (0.70 less than P less than 0.80). There was also no difference between the results as regards limb fitting, ambulation, occupational, or social status. It is concluded that the choice between the two methods can be based merely upon surgical skill and the ischaemic changes in the lower leg. Although the two-stage amputation technique entails an additional operation, several authors have advocated this approach to deal with wet gangrene because it allows primary wound closure with a reduced chance of wound infection. To examine this issue, 47 patients with necrotizing wet gangrene of the foot were randomized prospectively to receive either a one-stage amputation (definitive below- or above-knee amputation with delayed secondary skin closure in 3 to 5 days) or a two-stage amputation (open ankle guillotine amputation followed by definitive, closed below- or above-knee amputation). Antibiotic coverage was standardized with clindamycin and gentamicin used in all patients. Preoperative blood cultures and intraoperative foot cultures were obtained, as well as cultures from the deep muscle and lymphatic area along the saphenous vein to determine the presence of bacteria at the level of initial amputation. Twenty-four patients (11 diabetic and 13 nondiabetic) were randomized to the one-stage procedure. Twenty-three patients (14 diabetic and nine nondiabetic) were randomized to the two-stage procedure. Five of 24 patients in the one-stage group (21%) had positive muscle cultures vs 10 of 23 patients in the two-stage group (43%). Two of 24 patients in the one-stage group (8%) had positive lymphatic cultures vs 7 of 23 patients in the two-stage group (30%). Five of 24 patients in the one-stage group (21%) had wound complications attributable to the amputation technique vs none of 23 patients in the two-stage group (p = 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
Evidence suggests that the choice of amputation technique has no effect on outcome and can, therefore, be a simple matter of surgeon preference. Factors which might influence this include previous experience of a particular technique, the extent of non-viable tissue, and the location of pre-existing surgical scars.