The British journal of surgery
-
Randomized Controlled Trial Multicenter Study
Economic evaluation of a randomized controlled trial of ultrasound therapy for hard-to-heal venous leg ulcers.
A pragmatic, multicentre randomized controlled trial (VenUS III) was conducted to determine whether low-dose ultrasound therapy increased the healing rate of hard-to-heal leg ulcers. This study was a cost-effectiveness analysis of the trial data. ⋯ Ultrasound treatment was not cost-effective for hard-to-heal leg ulcers and should not be recommended for adoption in the NHS.
-
Randomized Controlled Trial Comparative Study
Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins.
This was the long-term follow-up of a previously reported randomized clinical trial comparing endovenous laser ablation (EVLA) with cryostripping for great saphenous varicose veins. ⋯ In this study, no significant difference was demonstrated in late outcome after EVLA or cryostripping in patients with great saphenous varicose veins.
-
Randomized Controlled Trial
Randomized clinical trial of epidural, spinal or patient-controlled analgesia for patients undergoing laparoscopic colorectal surgery.
Epidural analgesia is considered fundamental in enhanced recovery protocols (ERPs). However, its value in laparoscopic colorectal surgery is unclear. The aim of this study was to examine the effects of different analgesic regimens on outcomes following laparoscopic colorectal surgery in fluid-optimized patients treated within an ERP. ⋯ Many of the outcomes in the epidural analgesia group were significantly worse than those in the spinal analgesia and PCA groups, suggesting that either of these two modalities could replace epidural analgesia.
-
The feasibility of randomized controlled trials (RCTs) in liver surgery using a single-component clinical endpoint is low as such endpoints require large sample sizes owing to their low incidence. A liver surgery-specific composite endpoint (CEP) could solve this problem. The aim of this study was to develop a liver surgery-specific CEP with well-defined components. ⋯ The proposed liver surgery-specific CEP consists of ascites, postresectional liver failure, bile leakage, intra-abdominal haemorrhage, intra-abdominal abscess and operative mortality. It has a considerably higher event rate than any of its components. Its use as the primary endpoint will increase the feasibility and comparability of RCTs in liver surgery.