腹腔镜与开腹胰体尾切除术（LAPOP）：一项单中心、非盲法、随机对照临床试验的研究方案。
Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial.
机构信息
Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
Department of Surgery, Blekinge Hospital, Karlskrona, Sweden and Department of Clinical Sciences, Lund University, Lund, Sweden.
出版信息
Trials. 2019 Jun 13;20(1):356. doi: 10.1186/s13063-019-3460-y.
BACKGROUND
Earlier nonrandomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss, and recovery. Only one randomized study has been conducted showing reduced time to functional recovery after LDP compared with ODP.
METHODS
LAPOP is a prospective randomized, nonblinded, parallel-group, single-center superiority trial. Sixty patients with lesions in the pancreatic body or tail that are found by a multidisciplinary tumor board to need surgical resection will be randomized to receive LDP or ODP. The primary outcome variable is postoperative hospital stay, and secondary outcomes include functional recovery (defined as no need for intravenous medications or fluids and as the ability of an ambulatory patient to perform activities of daily life), perioperative bleeding, complications, need for pain medication, and quality of life comparison.
DISCUSSION
The LAPOP trial will test the hypothesis that LDP reduces postoperative hospital stay compared with ODP.
TRIAL REGISTRATION
ISRCTN, 26912858 . Registered on 28 September 2015.
背景
早期的非随机研究表明，腹腔镜胰体尾切除术（LDP）在住院时间、出血量和恢复方面优于开腹胰体尾切除术（ODP）。仅有一项随机研究表明，LDP 术后的功能恢复时间较 ODP 缩短。
方法
LAPOP 是一项前瞻性随机、非盲、平行组、单中心优效性试验。60 例经多学科肿瘤委员会评估需要手术切除的胰体或胰尾病变患者将被随机分为 LDP 或 ODP 组。主要结局变量为术后住院时间，次要结局包括功能恢复（定义为无需静脉用药或补液，以及能自行活动的患者进行日常生活活动的能力）、围手术期出血、并发症、疼痛药物需求和生活质量比较。
讨论
LAPOP 试验将检验 LDP 可降低术后住院时间的假设。
试验注册
ISRCTN，26912858。于 2015 年 9 月 28 日注册。
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