Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial

The objectives of this trial are to test the hypothesis that uncut Roux-en-Y anastomosis can reduce postoperative complications and improve nutritional status more effectively than Billroth II anastomosis in gastric cancer patients after D2 gastrectomy.Methods/designThis multi-center, prospective, phase III, randomized controlled trial will compare the efficacy of uncut Roux-en-Y anastomosis versus Billroth II anastomosis in phase I –III patients with initial treatment of radical distal gastrectomy. Patients will be randomized to undergo either the intervention (uncut Roux-en-Y anastomosis) or the control (Billroth II anastomosis). We will recruit 832 patients who meet the trial eligibility criteria and will follow the patien ts after surgery to observe postoperative complications and nutrition status for 5 years. The primary assessment indices of the study are reflux gastritis, esophagitis, bile regurgitation, and anastomotic ulcer. The secondary assessment indices are nutritional status, quality of life, perioperativ e complications, overall survival rate, and others. When the number of cases reaches 400, an interim analysis will be performed to identify any evidence of definite superiority of the experimental intervention.DiscussionWe aim to test the hypothesis that uncut Roux-en-Y anastomosis can reduce postoperative complications and improve nutritional status more than Billroth II anastomosis in gastric cancer patients after D2 gastrectomy. The results of the trial ...
Source: Trials - Category: Research Source Type: clinical trials