作者
Sebastiano Biondo,Oriana Barrios,Loris Trenti,Eloy Espín,Francesco Bianco,Armando Falato,Silvia De Franciscis,Alejandro Solís,Esther Kreisler,Ana Blanco,Thomas Golda,Ricardo Frago,Doménico Fraccalvieri,Ana Gálvez,M. Verdaguer‐Tremolosa,Piero Alberti,Bernat Miguel
摘要
IMPORTANCE In patients operated on for low rectal cancer, 2-stage Turnbull-Cutait pull-through hand-sewn coloanal anastomosis provides benefits in terms of postoperative morbidity compared with standard hand-sewn coloanal anastomosis associated with diverting ileostomy and further ileostomy reversal. OBJECTIVE To compare long-term results of these 2 techniques after ultralow rectal resection for rectal cancer. DESIGN, Setting, and Participants In this randomized multicenter clinical trial, neither patients nor surgeons were blinded for technique. Patients were recruited in 3 centers. 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 (n = 46) or standard hand-sewn coloanal anastomosis associated with diverting ileostomy (n = 46). 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. After 6 to 10 days, the exteriorized colon was resected and a delayed hand-sewn coloanal anastomosis performed. For patients assigned to standard coloanal anastomosis, the hand-sewn coloanal anastomosis was performed with diverting ileostomy during the first operation. Ileostomy closure was scheduled after adjuvant treatment was completed in about 6 to 8 months. MAIN OUTCOME AND MEASURE The study aimed to compare the differences between the 2 groups in terms of long-term surgery-related morbidity, functional, and oncological outcomes at 3 years postoperatively. Data were analyzed from October 1, 2018, through October 31, 2021. RESULTS The 92 patients randomized in the first study were included for the 3-year follow-up. The overall morbidity rate in the 2 groups showed that 15 patients (16.3%) had complications with a difference of 6.52 (95% CI, −8.93 to 21.79). Nine patients (19.6%) and 6 patients (13.0%) in the 2-stage Turnbull-Cutait pull-through group and hand-sewn coloanal anastomosis group, respectively, had complications without statistically significant differences ( P = .57). Oncological results were comparable between the groups. Long-term fecal continence in the CCA and TCA groups, respectively, assessed using the Wexner Incontinence Score was 10.9 (5.50-15.5) vs 13.0 (7.25-16.0; P = .92), Low Anterior Resection Syndrome score was 32.0 (21.0-37.0) vs 34.0 (23.2-38.5; P = .76), and Colorectal Functional Outcome score was 38.5 (23.0-47.1) vs 40.8 (23.3-58.2; P = .30). CONCLUSIONS AND RELEVANCE In this study, after a 3-year follow-up period, 2-stage Turnbull-Cutait anastomosis for ultralow rectal cancer could be considered as a surgical alternative that has the valuable benefit of avoiding a temporary stoma with similar results in terms of morbidity, fecal continence, patient satisfaction, quality of life, and oncological outcomes when compared with hand-sewn coloanal anastomosis with ileostomy. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01766661