Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Palliative management of malignant rectosigmoidal obstruction. Colostomy vs. endoscopic stenting. A randomized prospective trial. Early closure of a multicenter randomized clinical trial of endoscopic stenting versus surgery for stage IV left-sided colorectal cancer. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Results of surgery for malignant bowel obstruction in advanced, unresectable, recurrent colorectal cancer. Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. The risks of screening: data from the Nottingham randomised controlled trial of faecal occult blood screening for colorectal cancer. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct.
Colonic stenting as a bridge to elective surgery is an alternative for emergency surgery in patients with acute malignant colonic obstruction, but its benefits are uncertain. We aimed to establish whether colonic stenting has better health outcomes than does emergency surgery.
                Patients with acute obstructive left-sided colorectal cancer were enrolled from 25 hospitals in the Netherlands and randomly assigned (1:1 ratio) to receive colonic stenting as a bridge to elective surgery or emergency surgery. The randomisation sequence was computer generated with permuted blocks and was stratified by centre; treatment allocation was concealed by use of a web-based application. Investigators and patients were unmasked to treatment assignment. The primary outcome was mean global health status during a 6-month follow-up, which was assessed with the QL2 subscale of the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30). Analysis was by intention to treat. This study is registered, number ISRCTN46462267.
                Between March 9, 2007, and Aug 27, 2009, 98 patients were assigned to receive colonic stenting (n=47 patients) or emergency surgery (n=51). Two successive interim analyses showed increased 30-day morbidity in the colonic stenting group, with an absolute risk increase of 0.19 (95% CI -0.06 to 0.41) in analysis of the first 60 patients (14 of 28 patients receiving colonic stenting vs 10 of 32 receiving emergency surgery), and an absolute risk increase of 0.19 (-0.01 to 0.37) in analysis of the first 90 patients (23 of 47 patients vs 13 of 43). In accordance with the advice of the data safety monitoring committee, the study was suspended on Sept 18, 2009, and ended on March 12, 2010. At the final analysis of 98 patients, mean global health status during follow-up was 63.0 (SD 23.8) in the colonic stenting group and 61.4 (SD 21.9) in the emergency surgery group; after adjustment for baseline values, mean global health status did not differ between treatment groups (-4.7, 95% CI -14.8 to 5.5, p=0.36). No difference was recorded between treatment groups in 30-day mortality (absolute risk difference -0.01, 95% CI -0.14 to 0.12, p=0.89), overall mortality (-0.02, -0.17 to 0.14, p=0.84), morbidity (-0.08, -0.27 to 0.11, p=0.43), and stoma rates at latest follow-up (0.09, -0.10 to 0.27, p=0.35). However, the emergency surgery group had an increased stoma rate directly after initial intervention (0.23, 0.04 to 0.40, p=0.016) and a reduced frequency of stoma-related problems (between-group difference -12.0, -23.7 to -0.2, p=0.046). The most common serious adverse events were abscess (three in the colonic stenting group vs four in the emergency surgery group), perforations (six vs none), and anastomotic leakage (five vs one), and the most common adverse events were pneumonia (three vs one) and wound infection (one vs three).
                Colonic stenting has no decisive clinical advantages to emergency surgery. It could be used as an alternative treatment in as yet undefined subsets of patients, although with caution because of concerns about tumour spread caused by perforations.
                None.
                Copyright © 2011 Elsevier Ltd. All rights reserved. Colostomy was the palliative treatment of choice in patients with malignant unresectable rectosigmoid obstruction. Palliative endoscopic treatment of malignant rectosigmoid obstruction by endoluminal self-expanding metallic stents is nowadays a well-established procedure.
                Twenty-two patients, referred for treatment with diagnosis of malignant obstruction of the rectosigmoid region presenting an advanced unresectable stage, were enrolled. Patients were randomly assigned into two treatment groups (endoscopic stenting vs colostomy) according to random-number tables. The length of procedure, morbidity and mortality rate, canalization of the gastrointestinal tract, restoration of oral intake and hospital stay were assessed.
                Endoscopic group: The median length of procedure was 36 minutes. No death was observed. None of the patients reported complications. All patients resumed bowel function within 24 hours. The restoration of oral intake was achieved one day after stent placement. The median hospital stay was 2.6 days. Colostomy group: The median length of the operation was 75.4 minutes. No mortality was reported. In 1 patient (9.1%) stoma prolapse was observed 3 days after the operation. Canalization of the gastrointestinal tract was restored when colostomy was opened (on postoperative day 3). All patients were able to resume oral feedings on postoperative day 3. The median hospital stay was 8.1 days.
                There were no statistically significant differences between the 2 groups concerning morbidity and mortality. Endoscopic stenting was significantly more effective concerning operative time, restoration of bowel function and oral intake and median hospitalization. Our results would suggest that endoscopically placed metal stents offer an effective alternative to surgical palliation in patients suffering from unresectable malignant rectosigmoid obstruction. The introduction of self-expandable metal stents has offered a promising alternative for palliation of malignant left-sided colonic obstruction. This randomized clinical trial aimed to assess whether a nonsurgical policy, with endoluminal stenting, is superior to surgical treatment in patients with stage IV left-sided colorectal cancer and imminent obstruction.
                Patients with incurable left-sided colorectal cancer who fulfilled the study criteria were randomly assigned to nonsurgical or surgical treatment. The primary outcome measure was survival in good health out of hospital (World Health Organization performance scores 0 or 1).
                A high number of serious adverse events in the nonsurgical arm led to premature closure of the trial. Ten patients were allocated to surgical treatment and 11 patients to nonsurgical palliation. The median survival in good health out of hospital during the first year was 56 days (interquartile range 7.5 - 338.5 days) in the surgical arm vs. 38 days (interquartile range 5.25 - 288.75 days) in the nonsurgical arm (P = 0.68). Eleven adverse events (six perforations) occurred in the nonsurgical arm vs. one adverse event in the surgical arm (P < 0.001). Of the six perforations, two were stent-related because they occurred at the proximal edge of the stent by erosion through a normal colon wall; one was probably stent-related (it was located in the region of the proximal half of the stent); one was a colon blowout; and two were late tumor perforations in patients on chemotherapy.
                The unexpected high rate of perforation in the nonsurgical arm might be specifically WallFlex-related or enteral stent-related in patients on chemotherapy and warrants attention. The development of non-surgical techniques for the relief of malignant low bileduct obstruction has cast doubt on the best way of relieving jaundice, particularly in patients fit for surgery whose life expectancy is more than a few weeks. We did a randomised prospective controlled trial comparing endoscopic stent insertion and surgical biliary bypass in patients with malignant low bileduct obstruction. 204 patients were randomised (surgery 103, stent 101); 3 subsequently proved to have benign disease and were excluded, leaving 101 surgical and 100 stented patients for assessment. Technical success was achieved in 94 surgical and 95 stented patients, with functional biliary decompression obtained in 92 patients in both groups. In stented patients, there was a lower procedure-related mortality (3% vs 14%, p = 0.01), major complication rate (11% vs 29%, p = 0.02), and median total hospital stay (20 vs 26 days, p = 0.001). Recurrent jaundice occurred in 36 stented patients and 2 surgical patients. Late gastric outlet obstruction occurred in 17% of stented patients and 7% of the surgical group. Despite the early benefits of stenting there was no significant difference in overall survival between the two groups (median survival: surgical 26 weeks; stented 21 weeks; p = 0.065). Endoscopic stenting and surgery are effective palliative treatments with the former having fewer early treatment-related complications and the latter fewer late complications. A prospective randomized controlled trial (RCT) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
                This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT.
                Patients for elective resection for colorectal cancer were offered trial entry. Participants were stratified by sex and requirement for a total mesorectal excision and centrally randomized. Multimodal patients received intravenous fluid restriction, unrestricted oral intake with prokinetic agents, early ambulation, and fixed regimen epidural analgesia. Control patients received intravenous fluids to prevent oliguria, restricted oral intake until return of bowel motility, and weaning regimen epidural analgesia. Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets. Discharge decision was made using pre-agreed criteria. The primary endpoint was postoperative stay, and achievement of independence milestones. Secondary endpoints were postoperative complications, readmission rates, and mortality. Analysis was by intention to treat.
                Seventy patients were recruited. Approximately one fourth underwent TME. Median ages were similar (69.3 vs. 73.0 years). The median stay was significantly reduced in the multimodal group (5 vs. 7 days; P < 0.001, Mann-Whitney U test). Patients in the control arm were 2.5 times as likely to require a postoperative stay of more than 5 days. Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions. There were 2 deaths, both controls.
                This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery. Morbidity and mortality are not increased. When conservative treatment fails in the management of patients with malignant bowel obstruction secondary to advanced, recurrent colorectal cancer, the attitude toward surgery is often less than enthusiastic because of the limited life expectancy. We report a retrospective review of 30 patients with unresectable intra-abdominal disease who underwent laparotomy for the relief of bowel obstruction. Normal bowel function was restored in 19 patients (63 percent). The failures included five patients (17 percent) who died as a result of surgical complications and six patients (20 percent) who despite the surgery had continuing obstruction. Postoperative complications occurred in eight patients (27 percent). The median survival was significantly improved in those who benefited from the operation (192 days vs. 26 days; P = 0.0001). Whether the obstruction occurred at one site or more than one site appeared not to influence the outcome of surgery. Obstruction recurred after a mean symptom-free interval of 120 days in eight of those relieved by the initial operation. Half of these patients responded to conservative treatment, and surgery was again beneficial in three of the remaining four. Our results justify a more positive approach toward this problem, and, when conservatism fails, laparotomy should be undertaken in those who are not terminally ill. To compare self-expanding metal stents with emergency open surgery in the treatment of obstructing left-sided colon cancer.
                A randomized controlled trial.
                An acute care hospital.
                Adult patients with an obstructing tumor between the splenic flexure and rectosigmoid junction.
                Successful 1-stage operation, cumulative operative time, blood loss, hospital stay, pain score, and postoperative complications.
                Forty-eight patients were analyzed. Twenty-four underwent endoluminal stenting followed by laparoscopic resection and 24 underwent emergency open surgery. The 2 groups were matched for age, sex, body mass index, and disease staging. Patients in the endolaparoscopic group had significantly less cumulative blood loss and lower pain, incidence of anastomotic leak, and wound infection. Significantly more patients in the endolaparoscopic group had a successful 1-stage operation performed (16 vs 9, P = .04). None of the patients in the endolaparoscopic group had a permanent stoma compared with 6 patients in the emergency open surgery group (P = .03).
                Self-expanding metal stents serve as a safe and effective bridge to subsequent laparoscopic surgery in patients with obstructing left-sided colon cancer. This endolaparoscopic approach makes a 1-stage operation more feasible, is associated with reduced incidence of stoma creation, and allows patients with malignant large-bowel obstruction to enjoy the full benefit of minimally invasive surgery. Trial Registration clinicaltrials.gov Identifier: NCT00654212. To determine the harm that ensues from faecal occult blood (FOB) screening for colorectal cancer.
                150 251 people were randomly allocated either to receive biennial Haemoccult FOB tests (n =75 253) or not to be contacted (n=74 998). Study group patients returning positive tests were offered colonic investigation; 1774 underwent complete investigation of the colon.
                There was no significant difference in the stage at presentation of interval versus control group cancers. Survival in the interval cancer group was significantly prolonged compared with the control group. Sensitivity for colonoscopy or flexible sigmoidoscopy and double contrast barium enema (DCBE) was 96.7%. There were no complications of DCBE but seven (0.5%) complications of colonoscopy, of which six required surgical intervention. There were no colonoscopy related deaths. No patients without colorectal cancer died within 30 days of colonic investigation. Five patients died within 30 days of surgery for screen detected colorectal neoplasia and a further two died without having surgery. Six patients died after 30 days but within two years of surgery for screen detected benign adenomas or stage A cancers; in all cases the cause of death was not related to colorectal cancer.
                There was investigation related morbidity but no mortality and little to support overdiagnosis bias. The group returning falsely negative tests had a better outcome compared with the whole control group. There is a negative side to any screening programme but mortality reduction in this and other trials suggests that a national programme of colorectal cancer screening should be given consideration. Endoscopic insertion of biliary stents is the preferred method of palliation for inoperable malignant biliary obstruction; however, migration and clogging are frequent problems with conventional endoprostheses. We sought to determine if expandable metal stents offer improved palliation compared to conventional stents. Sixty-two patients with common bile duct lesions were randomized to receive polyethylene or metal stents. Stents were placed endoscopically or by the combined percutaneous-endoscopic route. Early results (< 1 month) were similar in both groups. Long-term follow-up (n = 28 polyethylene, median: 5 months; n = 27 metal, median: 5 months) showed a higher stent failure rate in the polyethylene (n = 12; 43%) compared to the metal group (n = 6; 22%). The incidence of cholangitis was significantly higher (p < 0.05) in the polyethylene (n = 10; 36%) compared to the metal group (n = 4; 15%). Life-table analysis showed a significantly reduced incidence of stent failure (p = 0.0035) in the metal stent compared to the polyethylene group. The total duration of hospital stay for treatment of stent related problems was significantly higher in the polyethylene (11.8 +/- 3 days) compared to the metal group (4 +/- 1.9 days; p = 0.02). The costs for retreatment because of stent failure were significantly higher in the plastic (DM 5900 +/- 1516) compared to the metal group (DM 2070 +/- 977). As a result, the overall costs (treatment of stent related complications & stents) were higher in the polyethylene group (DM 6000 +/- 1500).(ABSTRACT TRUNCATED AT 250 WORDS)
The use of colonic stent in malignant colorectal obstruction seems to have no advantage over emergency surgery. The clinical success rate was statistically higher in emergency surgery group. However, use of colorectal stents seems to be as safe in the malignant colorectal obstruction as the emergency surgery with no statistically significant difference in the mortality and morbidity. Colorectal stents are associated with acceptable stent perforation, migration and obstruction rates. The advantages of colorectal stent includes shorter hospital stay and procedure time and less blood loss. However, due to the variability in the sample size and trial designs in the included studies, further randomised trials with bigger sample size and well defined trial design are needed to achieve the robust evidence.