BACKGROUND: Surgical management of left colonic cancer presenting as an acute obstruction remains controversial and still is associated with high mortality and morbidity rates. Recently, self-expandable metallic stents (SEMS) have been used as a bridge to surgery in an attempt to decompress the colon and then allow elective one-stage surgical resection without stoma placement. This study aimed to compare the outcomes of emergency surgery alone with emergency placement of colonic SEMS as a bridge to surgery in terms of efficiency and reduction of the stoma placement rate. METHODS: A multicenter prospective, randomized, controlled trial was conducted according to the consolidated standards of reporting trials (CONSORT) Statement criteria. Patients eligible for the study were randomized to either emergency surgery or emergency SEMS as a bridge to surgery. The primary outcome was the need for a stoma (temporary or permanent) for any reason. The secondary end points were mortality, morbidity, and length of hospital stay. RESULTS:Nine centers participated in the trial. Among the 70 patients eligible for the study, 60 were randomized and included for the final analysis, 30 patients in each group. Seven patients were randomized but did not fulfill the entry requirements, whereas three further eligible patients were not randomized for various reasons. Concerning the primary outcome, 17 patients in the surgery group sustained a stoma placement versus 13 patients in the SEMS group (p=0.30). No statistically significant difference was noted concerning the secondary outcomes. A total of 16 attempts at SEMS placement (53.3%) were technical failures. Two colonic perforations directly related to the stent placement procedure occurred among the 30 randomized patients and 1 perforation occurred among the nonrandomized patients, leading to premature closure of inclusions in the study before the expected number of 80 patients was reached. CONCLUSION: This randomized trial failed to demonstrate that emergency preoperative SEMS for patients presenting with acute left-sided malignant colonic obstruction could significantly decrease the need for stoma placement.
RCT Entities:
BACKGROUND: Surgical management of left colonic cancer presenting as an acute obstruction remains controversial and still is associated with high mortality and morbidity rates. Recently, self-expandable metallic stents (SEMS) have been used as a bridge to surgery in an attempt to decompress the colon and then allow elective one-stage surgical resection without stoma placement. This study aimed to compare the outcomes of emergency surgery alone with emergency placement of colonic SEMS as a bridge to surgery in terms of efficiency and reduction of the stoma placement rate. METHODS: A multicenter prospective, randomized, controlled trial was conducted according to the consolidated standards of reporting trials (CONSORT) Statement criteria. Patients eligible for the study were randomized to either emergency surgery or emergency SEMS as a bridge to surgery. The primary outcome was the need for a stoma (temporary or permanent) for any reason. The secondary end points were mortality, morbidity, and length of hospital stay. RESULTS: Nine centers participated in the trial. Among the 70 patients eligible for the study, 60 were randomized and included for the final analysis, 30 patients in each group. Seven patients were randomized but did not fulfill the entry requirements, whereas three further eligible patients were not randomized for various reasons. Concerning the primary outcome, 17 patients in the surgery group sustained a stoma placement versus 13 patients in the SEMS group (p=0.30). No statistically significant difference was noted concerning the secondary outcomes. A total of 16 attempts at SEMS placement (53.3%) were technical failures. Two colonic perforations directly related to the stent placement procedure occurred among the 30 randomized patients and 1 perforation occurred among the nonrandomized patients, leading to premature closure of inclusions in the study before the expected number of 80 patients was reached. CONCLUSION: This randomized trial failed to demonstrate that emergency preoperative SEMS for patients presenting with acute left-sided malignant colonic obstruction could significantly decrease the need for stoma placement.
Authors: E Tejero; R Fernández-Lobato; A Mainar; C Montes; I Pinto; L Fernández; E Jorge; R Lozano Journal: Dis Colon Rectum Date: 1997-04 Impact factor: 4.585
Authors: Hester Yui Shan Cheung; Chi Chiu Chung; Wilson Wen Chieng Tsang; James Cheuk Hoo Wong; Kevin Kwok Kay Yau; Michael Ka Wah Li Journal: Arch Surg Date: 2009-12
Authors: H S Tilney; R E Lovegrove; S Purkayastha; P S Sains; G K Weston-Petrides; A W Darzi; P P Tekkis; A G Heriot Journal: Surg Endosc Date: 2006-12-09 Impact factor: 4.584
Authors: Cristina Martinez-Santos; Rosa F Lobato; José Manuel Fradejas; Isabel Pinto; Pablo Ortega-Deballón; Mariano Moreno-Azcoita Journal: Dis Colon Rectum Date: 2002-03 Impact factor: 4.585