Laparoscopic versus open distal pancreatectomy (LAPOP), study protocol for a single center, non-blinded randomized controlled trial

Abstract Background Earlier non-randomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous in comparison to 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 to ODP. Methods LAPOP is a prospective randomized, non-blinded, 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 LDP or ODP. The primary outcome variable is post-operative hospital stay and secondary outcomes include functional recovery (defined as no need for intravenous medications or fluids as well as ambulatory patient able to perform activities of daily live), perioperative bleeding, complications, need of pain medication and quality of life comparison. Discussion The LAPOP trial will test the hypothesis that LDP reduces post-operative hospital stay compared to ODP Registration of trial ISRCTN:26912858, date of registration 28/9 2015