Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial.

BACKGROUND: Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality, and remain one of the most frequent surgical complications. In prospective trials with adequate follow-up, more than 20 % of patients undergoing elective colorectal surgery are affected and methods to reduce surgical site infections are urgently needed. Negative-pressure incision therapy is a novel intervention that holds promise to reduce postoperative wound infection rates, but has not yet been rigorously tested in a randomized controlled trial. METHODS/DESIGN: The aim is to investigate whether the postoperative application of a negative-pressure incision therapy device for 5-7 days reduces the rate of surgical site infections following open elective colorectal surgery by 50 %. This is a randomized, controlled, observer-blinded multicentre clinical trial with two parallel study groups. The primary outcome measure will be the rate of surgical site infections within 30 days postoperatively. Surgical site infections are defined according to criteria of the US Centers for Disease Control and Prevention. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 5 % (two-sided) and the sample size (n = 170 per group) is determined to assure a power of 80 %. DISCUSSION: The Poniy trial will explore whether the rate of surgical site infections can be reduced by the application of a negative-pressure incision therapy device in patients undergoing open elective colorectal surgery. Its pragmatic design guarantees high external validity and clinical relevance. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00006199 .

Outcome after surgery for acute right-sided colonic ischemia without feasible vascular intervention: a single center experience of 58 patients over 6 years.

BACKGROUND: The predilection site of non-occlusive mesenteric ischemia is the right-sided colon. Surgical exploration followed by segmental bowel resection and primary anastomosis or ileostomy is recommended, if vascular interventions are not feasible and conservative treatment fails. We assessed the outcome of patients in this life-threatening condition. METHODS: From a prospective database 58 patients with urgent surgery for acute right-sided colonic ischemia without feasible vascular intervention (as a surrogate for non-occlusive mesenteric ischemia) were identified. Retrospectively the patients' characteristics, reason for ischemia, extent of resection, rate of ileostomy creation, 30 day and one year mortality, and rate of ileostomy-reversal at one year postoperative were assessed. RESULTS: Radiologically mesenteric arteriosclerotic disease was present in 54% of the patients. Vaso-occlusive mesenteric disease was suspected in 15% of the patients, but not confirmed intra-operatively. Ten patients underwent (extended) right-sided hemicolectomy with primary anastomosis (30-days mortality 20%, 1-year mortality 30%). Sixteen patients had (extended) right-sided hemicolectomy with creation of an ileostomy (30-days mortality 44%, 1-year mortality 86%, ostomy reversal in one patient). Twenty-five patients had (sub-) total colectomy with ileostomy creation (30-days mortality 60%, 1-year mortality 72%, ostomy reversal in two patients). Seven patients had exploration only (30-days mortality 86%, 1-year mortality 86%). Overall, the 30-days mortality-rate was 52% and the 1-year mortality-rate was 70%. Only 7% of the patients requiring an ostomy experienced ostomy-reversal. CONCLUSIONS: Patients with urgent surgery for acute right-sided colonic ischemia without feasible vascular intervention have a very high short and long-term mortality. The rate of ostomy-reversal is very low.

Wound edge protectors in open abdominal surgery to reduce surgical site infections: a systematic review and meta-analysis.

IMPORTANCE: Surgical site infections remain one of the most frequent complications following abdominal surgery and cause substantial costs, morbidity and mortality. OBJECTIVE: To assess the effectiveness of wound edge protectors in open abdominal surgery in reducing surgical site infections. EVIDENCE REVIEW: A systematic literature search was conducted according to a prespecified review protocol in a variety of data-bases combined with hand-searches for randomized controlled trials on wound edge protectors in patients undergoing laparotomy. A qualitative and quantitative analysis of included trials was conducted. FINDINGS: We identified 16 randomized controlled trials including 3695 patients investigating wound edge protectors published between 1972 and 2014. Critical appraisal uncovered a number of methodological flaws, predominantly in the older trials. Wound edge protectors significantly reduced the rate of surgical site infections (risk ratio 0.65; 95%CI, 0.51-0.83; p = 0.0007; I2 = 52%). The results were robust in a number of sensitivity analyses. A similar effect size was found in the subgroup of patients undergoing colorectal surgery (risk ratio 0.65; 95%CI, 0.44-0.97; p = 0.04; I2 = 56%). Of the two common types of wound protectors double ring devices were found to exhibit a greater protective effect (risk ratio 0.29; 95%CI, 0.15-0.55) than single-ring devices (risk ratio 0.71; 95%CI, 0.54-0.92), but this might largely be due to the lower quality of available data for double-ring devices. Exploratory subgroup analyses for the degree of contamination showed a larger protective effect in contaminated cases (0.44; 95%CI, 0.28-0.67; p = 0.0002, I2 = 23%) than in clean-contaminated surgeries (0.72, 95%CI, 0.57-0.91; p = 0.005; I2 = 46%) and a strong effect on the reduction of superficial surgical site infections (risk ratio 0.45; 95%CI, 0.24-0.82; p = 0.001; I2 = 72%). CONCLUSIONS AND RELEVANCE: Wound edge protectors significantly reduce the rate of surgical site infections in open abdominal surgery. Further trials are needed to explore their effectiveness in different risk constellations.

The evidence based dilemma of intraperitoneal drainage for pancreatic resection - a systematic review and meta-analysis.

BACKGROUND: Routine placement of intraperitoneal drains has been shown to be ineffective or potentially harmful in various abdominal surgical procedures. Studies assessing risks and benefits of abdominal drains for pancreatic resections have demonstrated inconsistent results. We thus performed a systematic review of the literature and meta-analyzed outcomes of pancreatic resections with and without intraoperative placement of drains. METHODS: A database search according to the PRISMA guidelines was performed for studies on pancreatic resection with and without intraperitoneal drainage. The subgroup 'pancreaticoduodenectomy' was analyzed separately. The quality of studies was assessed using the MINORS and STROBE criteria. Pooled estimates of morbidity, mortality and length of hospital stay were calculated using random effects models. RESULTS: Only two randomized trials were identified. Their results were contradictory. We thus included six further, retrospective studies in the meta-analysis. However, with I2 = 68% for any kind of complication, the estimate of inter-study heterogeneity was high. While overall morbidity after any kind of pancreatic resection was lower without drains (p = 0.04), there was no significant difference in mortality rates. In contrast, pooled estimates of outcomes after pancreaticoduodenectomy demonstrated no differences in morbidity (p = 0.40) but increased rates of intraabdominal abscesses (p = 0.04) and mortality (p = 0.04) without intraperitoneal drainage. CONCLUSION: Although drains are associated with slightly increased morbidity for pancreatic resections, routine omission of drains cannot be advocated, especially after pancreaticoduodenectomy. While selective drainage seems reasonable, further efforts to generate more reliable data are questionable because of the current studies and the presumed small differences in outcomes. TRIAL REGISTRATION: Systematic review registration number CRD42014007497.

Colorectal cancer surgery remains effective with rising patient age.

BACKGROUND: The incidence of colorectal cancer rises disproportionally in aging persons. With a shift towards higher population age in general, an increasing number of older patients require adequate treatment. This study aims to investigate differences between young and elderly patients who undergo resection for colorectal cancer, regarding clinical characteristics, morbidity, and prognosis. METHODS: By retrospective analysis of 6 years (2007 to 2012) of a prospectively documented database, a total of 636 patients were identified who underwent oncological resection for colorectal cancer at our institution. Of this total, all 569 patients with primary colorectal adenocarcinoma were included. Four hundred ten patients were 74 years or younger and 159 were 75 years or older. The median follow-up was 22 months. RESULTS: Older patients had significantly more comorbidities (85 % vs. 56 %, p < 0.001) and a higher ASA score (p < 0.001). The mean length of stay in the hospital was longer (24 vs. 20 days, p = 0.002), as was the length of postoperative intensive care stay (4 vs. 2 days, p = 0.003). However, elderly patients did not have significantly higher rates of intraoperative complications or surgical morbidity. Tumor-specific 2-year survival was 83 ± 4 % for the elderly and 87 ± 2 % for the younger patients, which was not significantly different (p = 0.90). CONCLUSIONS: Long-term outcome after oncologic resection for colorectal cancer does not differ between elderly and younger patients. Age in general should not be considered as a limiting factor for colorectal cancer surgery or tumor-specific prognosis.