Stent as bridge to surgery for left-sided malignant colonic obstruction reduces adverse events and stoma rate compared with emergency surgery: results of a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Twenty years after the first description of the technique, the debate is still open on the role of self-expandable metallic stent (SEMS) placement as a bridge to elective surgery for symptomatic left-sided malignant colonic obstruction. The aim was to compare morbidity rates after colonic stenting bridge to surgery (SBTS) versus emergency surgery (ES) for left-sided malignant obstruction. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) on SBTS or ES for acute symptomatic malignant left-sided large bowel obstruction. The primary outcome was overall morbidity within 60 days after surgery. RESULTS: The meta-analysis included 8 RCTs and 497 patients. Overall mortality within 60 days after surgery was 9.6% in SBTS-treated patients and 9.9% in ES-treated patients (relative risk [RR], 0.99; P = .97). Overall morbidity within 60 days after surgery was 33.9% in SBTS-treated patients and 51.2% in ES-treated patients (RR, 0.59; P = .023). The temporary stoma rate was 33.9% after SBTS and 51.4% after ES (RR, 0.67; P < .001). The permanent stoma rate was 22.2% after SBTS and 35.2% after ES (RR, 0.66; P = .003). Primary anastomosis was successful in 70.0% of SBTS-treated patients and 54.1% of ES-treated patients (RR, 1.29; P = .043). CONCLUSIONS: SBTS was associated with lower short-term overall morbidity and lower rates of temporary and permanent stoma. Depending on multiple factors such as local expertise, clinical status including level of obstruction, and level of certainty of diagnosis, SBTS does offer some advantages with less risk than ES for left-sided malignant colonic obstruction in the short term.

The role of stents in the management of colorectal complications: a systematic review.

BACKGROUND: Complications in colorectal surgery include a wide range of clinical conditions, which increase mortality, morbidity, hospital stay and costs. In some cases, the placement of a self-expanding metal stent may represent a possible therapeutic strategy, avoiding further surgery. METHODS: In order to verify the feasibility and safety of the technique, we reviewed the medical literature, between January 1997 and 2015, selecting 32 studies. Inclusion criteria were based on Preferred Reporting Items for Systematic reviews and Meta-Analyses recommendations. RESULTS: The estimated rate of early success was 73.3% (95% CI 66.3-79.3), raising from 25 to 68% in the time frame 1997-2007. The rate of early complications was 31.4% (95% CI 25.3-38.3%), progressively decreasing from 75 to 43% up to 2009. The rate of surgery for acute complication was 9.3% (95% CI 6.0-14.2%), reduced on time course from 25 to 9%. The rate of closure of dehiscence was 74.5% (95% CI 62.8-83.5%), while the rate of long-lasting success was 57.3% (95% CI 50.3-64.0%). CONCLUSIONS: Endoscopic stenting in the early postoperative management of anastomotic complications after colorectal surgery should be considered in patients with minimal risk for sepsis, as a safe and often effective alternative to surgery. However, in order to establish the safety and efficacy of this technique, prospective studies involving a larger cohort of patients are required.

International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video).

BACKGROUND: The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC closure of GI defects. OBJECTIVE: To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. DESIGN: Multicenter, retrospective study. SETTING: Multiple, international, academic centers. PATIENTS: Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. INTERVENTIONS: OTSC placement to attempt closure of GI defects. MAIN OUTCOME MEASUREMENTS: Long-term success of the procedure. RESULTS: A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) (P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). LIMITATIONS: Retrospective design and multiple operators with variable expertise with the OTSC device. CONCLUSION: OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.

Systematic review and meta-analysis of endoscopic submucosal dissection versus transanal endoscopic microsurgery for large noninvasive rectal lesions.

BACKGROUND: For almost 30 years, transanal endoscopic microsurgery (TEM) has been the mainstay treatment for large rectal lesions. With the advent of endoscopic submucosal dissection (ESD), flexible endoscopy has aimed at en bloc R0 resection of superficial lesions of the digestive tract. This systematic review and meta-analysis compared the safety and effectiveness of ESD and full-thickness rectal wall excision by TEM in the treatment of large nonpedunculated rectal lesions preoperatively assessed as noninvasive. METHODS: A systematic review of the literature published between 1984 and 2010 was conducted (Registration no. CRD42012001882). Data were integrated with those from the original databases requested from the study authors when needed. Pooled estimates of the proportions of patients with en bloc R0 resection, complications, recurrence, and need for further treatment in the ESD and TEM series were compared using random-effects single-arm meta-analysis. RESULTS: This review included 11 ESD and 10 TEM series (2,077 patients). The en bloc resection rate was 87.8 % (95 % confidence interval [CI] 84.3-90.6) for the ESD patients versus 98.7 % (95 % CI 97.4-99.3 %) for the TEM patients (P < 0.001). The R0 resection rate was 74.6 % (95 % CI 70.4-78.4 %) for the ESD patients versus 88.5 % (95 % CI 85.9-90.6 %) for the TEM patients (P < 0.001). The postoperative complications rate was 8.0 % (95 %, CI 5.4-11.8 %) for the ESD patients versus 8.4 % (95 % CI 5.2-13.4 %) for the TEM patients (P = 0.874). The recurrence rate was 2.6 % (95 % CI 1.3-5.2 %) for the ESD patients versus 5.2 % (95 % CI 4.0-6.9 %) for the TEM patients (P < 0.001). Nevertheless, the rate for the overall need of further abdominal treatment, defined as any type of surgery performed through an abdominal access, including both complications and pathology indications, was 8.4 % (95 % CI 4.9-13.9 %) for the ESD patients versus 1.8 % (95 % CI 0.8-3.7 %) for the TEM patients (P < 0.001). CONCLUSIONS: The ESD procedure appears to be a safe technique, but TEM achieves a higher R0 resection rate when performed in full-thickness fashion, significantly reducing the need for further abdominal treatment.

Laparoscopy for rectal cancer reduces short-term mortality and morbidity: results of a systematic review and meta-analysis.

BACKGROUND: Although definitive long-term results are not yet available, the global safety of laparoscopic surgery for rectal cancer treatment remains controversial. We evaluated differences in the safety of laparoscopic rectal resection versus open surgery for cancer. METHODS: A systematic review from 2000 to 2011 was performed searching the Medline and Embase databases (prospero registration CRD42012002406). We included randomized and prospective controlled clinical studies comparing laparoscopic and open resection for rectal cancer. Primary end points were 30-day mortality and overall morbidity. Then a meta-analysis was conducted by a fixed-effect model, performing a sensitivity analysis by a random-effect model. Relative risk (RR) was used as an indicator of treatment effect; a RR of less than 1.0 was in favor of laparoscopy. Publication bias was assessed by funnel plot and heterogeneity by the I (2) test and subgroup analysis on surgical and medical complications. RESULTS: Twenty-three studies, representing 4,539 patients, met the inclusion criteria; eight were randomized for a total of 1,746 patients. Mortality was observed in 1.0 % of patients in the laparoscopic group and in 2.4 % of patients in the open group. The overall RR was 0.46 (95 % confidence interval 0.21-0.99, p = 0.048). The raw incidence of overall complications was lower in the laparoscopic group (31.8 %) compared to the open group (35.4 %). The overall RR was 0.83 (95 % confidence interval 0.76-0.91, p < 0.001). CONCLUSIONS: On the basis of evidence of both randomized and prospective controlled series, mortality and morbidity RR, including subgroup analysis, were significantly lower after laparoscopic compared to open surgery.

Efficacy of the over-the-scope clip (OTSC) for treatment of colorectal postsurgical leaks and fistulas.

BACKGROUND: Colorectal postsurgical leaks and fistulas are severe complications that dramatically increase morbidity and mortality. The aim of this study was to evaluate the clinical impact of over-the-scope clip (OTSC) closure to seal the visceral wall in the management of acute and chronic colorectal postsurgical leaks and fistulas. METHODS: We reviewed our prospective series of acute and chronic colorectal postsurgical leaks and fistulas observed between April 2008 and September 2011 and treated by OTSC. Indications were all cases with an orifice <15 mm in maximum diameter with no extraluminal abscess and luminal stenosis. RESULTS: Endoscopic OTSC closure was performed in 14 consecutive patients (mean defect = 9.1 mm in diameter) by means of 10.5- or 12-mm clips, depending on the wall defect diameter. In eight cases, the indication was an acute leak and in six cases a chronic leak, mainly after anterior rectal resection; two cases were complicated by a rectovaginal fistula and in two other cases by a colocutaneous fistula. OTSC treatment was used to complete endoscopic vacuum-assisted closure of a large defect in three cases. The overall success rate was 86 % (12/14): 87 % (7/8) in acute and 83 % (5/6) in chronic cases. No OTSC-related complications occurred. Further surgery was required in one case. CONCLUSION: Endoscopic OTSC closure of colorectal postsurgical leaks and fistulas is a safe technique, with a high success rate in both acute and chronic cases, including rectovaginal and colocutaneous fistulas.

Robotic-Assisted Colonoscopy Platform with a Magnetically-Actuated Soft-Tethered Capsule.

Background and Aims: Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide. Despite offering a prime paradigm for screening, CRC screening is often hampered by invasiveness. Endoo is a potentially painless colonoscopy method with an active locomotion tethered capsule offering diagnostic and therapeutic capabilities. Materials and Methods: The Endoo system comprises a soft-tethered capsule, which embeds a permanent magnet controlled by an external robot equipped with a second permanent magnet. Capsule navigation is achieved via closed-loop interaction between the two magnets. Ex-vivo tests were conducted by endoscopy experts and trainees to evaluate the basic key features, usability, and compliance in comparison with conventional colonoscopy (CC) in feasibility and pilot studies. Results: Endoo showed a 100% success rate in operating channel and target approach tests. Progression of the capsule was feasible and repeatable. The magnetic link was lost an average of 1.28 times per complete procedure but was restored in 100% of cases. The peak value of interaction forces was higher in the CC group than the Endoo group (4.12N vs. 1.17N). The cumulative interaction forces over time were higher in the CC group than the Endoo group between the splenic flexure and mid-transverse colon (16.53Ns vs. 1.67Ns, p < 0.001), as well as between the hepatic flexure and cecum (28.77Ns vs. 2.47Ns, p = 0.005). The polyp detection rates were comparable between groups (9.1 ± 0.9% vs. 8.7 ± 0.9%, CC and Endoo respectively, per procedure). Robotic colonoscopies were completed in 67% of the procedures performed with Endoo (53% experts and 100% trainees). Conclusions: Endoo allows smoother navigation than CC and possesses comparable features. Although further research is needed, magnetic capsule colonoscopy demonstrated promising results compared to CC.

Long-term efficacy of endoscopic vacuum therapy for the treatment of colorectal anastomotic leaks.

BACKGROUND: Anastomotic leaks are a severe complication after colorectal surgery. We aimed to evaluate the long-term efficacy of endoscopic vacuum therapy for their treatment. METHODS: Retrospective review of a series of post-surgical colorectal leaks treated with endoscopic vacuum therapy, with minimum follow-up of 1 year. Generalized peritonitis or haemodynamic instability was considered contraindication to endoscopic treatment. RESULTS: Endoscopic vacuum therapy was applied in 14 patients with colorectal leak, in 2 cases complicated by recto-vaginal fistula. Overall success rate was 79%, favoured by early beginning of treatment (90%) and presence of a stoma (100%) and no preoperative radiotherapy (86%). Median duration of treatment was 12.5 sessions (range 4-40). Median time for complete healing was 40.5 days (range 8-114), for a median cost of treatment of 3125 Euros. No complication related to endoscopic vacuum therapy was observed. Further surgery was required in 3 cases. CONCLUSION: Endoscopic vacuum therapy is a safe treatment for post-surgical leaks, with high success rates.

Laparoscopy for extraperitoneal rectal cancer reduces short-term morbidity: Results of a systematic review and meta-analysis.

BACKGROUND: The role of laparoscopy in the treatment of extraperitoneal rectal cancer is still controversial. The aim of the study was to evaluate differences in safety of laparoscopic rectal resection for extraperitoneal cancer, compared with open surgery. MATERIALS AND METHODS: A systematic review from 2000 to July 2012 was performed searching the MEDLINE and EMBASE databases (PROSPERO registration number CRD42012002406). We included randomized and prospective controlled clinical studies comparing laparoscopic and open resection for rectal cancer. Primary endpoints were 30-day mortality and morbidity. Then a meta-analysis was conducted by a fixed-effect model, performing a sensitivity analysis by a random-effect model. Relative risk (RR) was used as an indicator of treatment effect. RESULTS: Eleven studies, representing 1684 patients, met the inclusion criteria: four were randomized for a total of 814 patients. Mortality was observed in 1.2% of patients in the laparoscopic group and in 2.3% of patients in the open group, with an RR of 0.56 (95% CI 0.19-1.64, p = 0.287). The overall incidence of short-term complications was lower in the laparoscopic group (31.5%) compared to the open group (38.2%), with an RR of 0.83 (95% CI 0.73-0.94, p = 0.004). Surgical complications, wound complications, blood loss and the need for blood transfusion, time for bowel movement recovery, food intake recovery, and hospital stay were significantly lower or less frequent in the laparoscopic group. The incidence of intra-operative injuries, anastomotic leakages, and surgical re-interventions was similar in the two groups. Only operative time was in favour of the open group. CONCLUSIONS: Based on the evidence of both randomized and prospective controlled series, mortality was lower after laparoscopy although not significantly so, while the short-term morbidity RR, including subgroup analysis, was significantly lower after laparoscopy for extraperitoneal rectal cancer compared to open surgery.

Experimental assessment of a novel robotically-driven endoscopic capsule compared to traditional colonoscopy.

BACKGROUND: Despite colonoscopy represents the conventional diagnostic tool for colorectal pathology, its undeniable discomfort reduces compliance to screening programmes. AIMS: To evaluate feasibility and accuracy of a novel robotically-driven magnetic capsule for colonoscopy as compared to the traditional technique. METHODS: Eleven experts and eleven trainees performed complete colonoscopy by robotic magnetic capsule and by conventional colonoscope in a phantom ex vivo model (artificially clean swine bowel). Feasibility, overall accuracy to detect installed pins, procedure elapsed time and intuitiveness were measured for both techniques in both operator groups. RESULTS: Complete colonoscopy was feasible in all cases with both techniques. Overall 544/672 pins (80.9%) were detected by experimental capsule procedure, while 591/689 pins (85.8%) were detected within conventional colonoscopy procedure (P=ns), thus establishing non-inferiority. With the experimental capsule procedure, experts detected 74.2% of pins vs. 87.6% detected by trainees (P<0.0001). Overall time to complete colon inspection by robotic capsule was significantly higher than by conventional colonoscopy (556±188s vs. 194±158s, respectively; P=0.0001). CONCLUSION: With the limitations represented by an ex vivo setting (artificially clean swine bowel and the absence of peristalsis), colonoscopy by this novel robotically-driven capsule resulted feasible and showed adequate accuracy compared to conventional colonoscopy.