METHODS: LT patients with renal dysfunction and/or obesity were enrolled in a phase-I clinical trial. DPR lasted 8-24 h depending on postoperative disposition. Primary outcome was percent of patients completing DPR. Secondary outcomes evaluated complications. Controls with either obesity (control-1) or both risk factors (obesity + renal dysfunction, control-2) were analyzed.
RESULTS: Fifteen patients were enrolled (seven with both criteria and eight with obesity alone). DPR was completed in 87 % of patients, with one meeting stopping criteria. Controls included 45 (control-1) and 24 (control-2) patients. Return to operating room, graft loss, and late infections were lower with DPR.
CONCLUSIONS: DPR appears to be safe in closed abdomens following LT, warranting a follow-up phase-II trial to assess efficacy.
方法:患有肾功能不全和/或肥胖的LT患者被纳入I期临床试验。DPR持续8-24小时,具体取决于术后处置。主要结果是完成DPR的患者百分比。次要结果评估并发症。具有肥胖(对照1)或同时具有危险因素(肥胖+肾功能不全,对照-2)进行分析。
结果:纳入了15例患者(7例符合两项标准,8例仅有肥胖)。87%的患者完成了DPR,一个会议停止标准。对照包括45名(对照-1)和24名(对照-2)患者。回到手术室,移植物丢失,DPR的晚期感染较低。
结论:DPR在LT术后腹部闭合时似乎是安全的,保证随访II期试验以评估疗效。