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Randomized controlled trial comparing primary and staged basilic vein transposition.

ABSTRACT: OBJECTIVE:It is unclear if brachio-basilic vein fistula should be performed as a primary or staged procedure, particularly for smaller basilic veins. Our aim was to report on a randomized controlled trial comparing these two techniques. METHODS:Sixteen patients with a basilic vein ?2.5?mm were randomized into primary transposed brachio-basilic vein (TBBV) fistula (n?=?9) and staged TBBV fistula (n?=?7). Patients with basilic veins enlarged by previous arteriovenous fistulas were excluded. Baseline characteristics of the two study groups, including vein size, were comparable (median basilic vein diameter 3.5?mm, range 2.8-4.1?mm). The staged group had a brachio-basilic vein fistula performed first followed by the transposition procedure performed at least 6?weeks later to allow the basilic vein to enlarge. TBBV fistula maturation at 10?weeks, primary, assisted-primary, and secondary patency were the primary outcome measures. Early failures were included in the calculation of patency rates. RESULTS:Transposed brachio-basilic vein fistula maturation rate after primary procedures (3/9, 33%) was lower compared to maturation rate after staged procedures (7/7, 100%, P?=?0.011, Fisher's exact test), which led to premature termination of the trial. Time to hemodialysis [median (interquartile range)] of primary and staged procedures was 54 (51.5-113.5)?days and 97 (93-126)?days, respectively (P?=?0.16). One-year primary and assisted-primary patency rates of primary and staged procedures were equivalent (44 vs 57%, P?=?0.76 and 44 vs 71%, P?=?0.29, respectively); however, there was a trend toward a better 1-year secondary patency after staged procedures (86 vs 44% for primary procedures, P?=?0.09). CONCLUSIONS:Among candidates for TBBV fistula with a small basilic vein, staged transposition achieves higher maturation rates compared to primary procedures, a difference reflected in long-term secondary patency. TRIAL REGISTRATION:www.ClinicalTrials.gov, identifier NCT01274117.

SUBMITTER: Kakkos SK

PROVIDER: S-EPMC4413520 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Randomized controlled trial comparing primary and staged basilic vein transposition.

Kakkos Stavros K SK Tsolakis Ioannis A IA Papadoulas Spyros I SI Lampropoulos George C GC Papachristou Evangelos E EE Christeas Nikolaos C NC Goumenos Dimitrios D Lazarides Miltos K MK

Frontiers in surgery 20150429

<h4>Objective</h4>It is unclear if brachio-basilic vein fistula should be performed as a primary or staged procedure, particularly for smaller basilic veins. Our aim was to report on a randomized controlled trial comparing these two techniques.<h4>Methods</h4>Sixteen patients with a basilic vein ≥2.5 mm were randomized into primary transposed brachio-basilic vein (TBBV) fistula (n = 9) and staged TBBV fistula (n = 7). Patients with basilic veins enlarged by previous arteriovenous fistulas were e ...[more]

PMID: 25973421

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Project description:STUDY OBJECTIVES:To evaluate the short-term efficacy and safety of electroacupuncture for the treatment of primary insomnia. DESIGN:Randomized, single-blind, placebo-controlled, parallel-group. SETTING:A university-based sleep clinic. PARTICIPANTS:Community sample of 60 Chinese adult volunteers who report having insomnia 3 or more nights per week, whose symptoms meet the DSM-IV criteria for primary insomnia for at least 3 months, and who have an Insomnia Severity Index total score of at least 15. Participants were screened with polysomnography and the Structured Clinical Interview for the DSM-IV prior to randomization. INTERVENTION:Electroacupuncture at Yintang (EX-HN3), Baihui (GV20), bilateral ear Shenmen, Sishencong (EX-HN1), and Anmian (EX) 3 times per week for 3 weeks or placebo acupuncture using Streitberger needles at the same points. MEASUREMENTS AND RESULTS:Self-reported questionnaires, 1-week sleep diaries, and 3-day actigraphy were collected at baseline and 1 week after treatment. The Insomnia Severity Index was used as the primary outcome measure. Both groups showed significant improvement compared with the pretreatment baseline. One-way analysis of covariance adjusted for baseline scores showed that there were significantly greater improvements in sleep efficiency by sleep diary and actigraphy in the electroacupuncture group. However, no significant between-group differences were observed in the Insomnia Severity Index and other outcome measures. The proportions of subjects having less than 30 minutes of wake after sleep onset and a sleep efficiency of at least 85% at the posttreatment visit were significantly higher in the electroacupuncture group. All adverse events were mild in severity. CONCLUSION:We found a slight advantage of electroacupuncture over placebo acupuncture in the short-term treatment of primary insomnia. Because of some limitations of the current study, further studies are necessary to verify the effectiveness of acupuncture for insomnia.

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Randomized controlled trial comparing primary and staged basilic vein transposition.

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Randomized controlled trial comparing primary and staged basilic vein transposition.

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