Importance: Two-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis seems to provide benefits in terms of postoperative morbidity compared with standard hand-sewn coloanal anastomosis associated with diverting ileostomy and further ileostomy reversal in patients operated on for low rectal cancer. Objective: To compare 30-day postoperative and 1-year follow-up results of Turnbull-Cutait pull-through hand-sewn coloanal anastomosis and standard hand-sewn coloanal anastomosis after ultralow rectal resection for rectal cancer. Design, Setting, and Participants: Multicenter randomized clinical trial. Neither patients nor surgeons were blinded for technique. Patients were recruited in 3 centers, Bellvitge University Hospital and Valle d'Hebron University Hospital in Spain and Instituto Nazionale Tumori Fondazione G. Pascale-Istituto di Ricovero e Cura a Carattere Scientifico in Italy. Patients undergoing ultralow anterior rectal resection needing hand-sewn coloanal anastomosis were randomly assigned to 2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis or standard hand-sewn coloanal anastomosis associated with diverting ileostomy. Data were analyzed between June 2012 and October 2018. Interventions: All patients underwent ultralow anterior resection. Patients assigned to the 2-stage Turnbull-Cutait pull-through group underwent exteriorization of a segment of left colon through the anal canal and, after 6 to 10 days, the exteriorized colon was resected and a delayed hand-sewn coloanal anastomosis was performed. For patients assigned to standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy at first operation. Closure of the ileostomy was planned after 6 to 8 months. Main Outcomes and Measures: Primary outcome was 30-day postoperative morbidity. For the standard hand-sewn coloanal anastomosis with diverting ileostomy group, overall postoperative morbidity includes 30-day postoperative complications of the ileostomy closure. Results: Ninety-two white patients, 72 men and 20 women, with a median age of 62 years, were randomized and included in the analysis. Forty-six patients received standard hand-sewn coloanal anastomosis with diverting ileostomy and 46 received the 2-stage pull-through hand-sewn coloanal anastomosis. Seven patients (15.2%) in the standard hand-sewn coloanal anastomosis group did not undergo reversal ileostomy, and 1 patient (2.2%) in the 2-stage pull-through hand-sewn coloanal anastomosis group did not undergo delayed coloanal anastomosis. The 30-day overall composite postoperative complications rate was similar between the 2 groups (34.8% in 2-stage pull-through hand-sewn coloanal anastomosis group vs 45.7% in standard hand-sewn coloanal anastomosis group; P =.40), with a difference of -10.9 (95% CI, -29.5 to 8.9). Conclusions and Relevance: The 2-stage pull-through hand-sewn coloanal anastomosis after ultralow anterior resection for low rectal cancer is safe and does not increase the postoperative morbidity rate compared with standard coloanal anastomosis with covering ileostomy followed by ileostomy closure. Trial Registration: ClinicalTrials.gov Identifier: NCT01766661..
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