A single blinded randomized controlled trial comparing semi-mechanical with hand-sewn cervical anastomosis after esophagectomy for cancer (SHARE-study)

Abstract

Objective: The aim was to compare leak rate between hand-sewn end-to-end anastomosis (ETE) and semi-mechanical anastomosis (SMA) after esophagectomy with gastric tube reconstruction. Background Data: The optimal surgical technique for creation of an anastomosis in the neck after esophagectomy is unclear. Methods: Patients with esophageal cancer undergoing esophagectomy with gastric tube reconstruction and cervical anastomosis were eligible for participation after written informed consent. Patients were randomized in 1:1 ratio. Primary endpoint was anastomotic leak rate defined as external drainage of saliva from the site of the anastomosis or intra-thoracic manifestation of leak. Secondary endpoints included anastomotic stricture rate at one year follow up, number of endoscopic dilatations, dysphagia-score, hospital stay, morbidity, and mortality. Patients were blinded for intervention. Results: Between August 2011 and July 2014, 174 patients with esophageal cancer underwent esophagectomy. Ninety-three patients were randomized to ETE (n = 44) or SMA (n = 49). Anastomotic leak occurred in 9 of 44 patients (20%) in the ETE group and 12 of 49 patients (24%) in the SMA group (absolute difference 4%, 95% CI −13% to +21%; p =.804). There was no significant difference in dysphagia at 1 year postoperatively (ETE 25% vs. SMA 20%; p =.628), in stricture rate (ETE 25% vs. 19% in SMA, p =.46), nor in median hospital stay (17 days in the ETE group, 13 days in the SMA group), morbidity (82% vs. 73%, p =.460) or mortality (0% vs. 4%, p =.175) between the groups.