[Show abstract][Hide abstract] ABSTRACT: 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.
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 %.
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.
Deutsches Register Klinischer Studien DRKS00006199.
[Show abstract][Hide abstract] ABSTRACT: Gastric cancer accounts for 5 % of cancer deaths. Proportions of older stomach cancer patients are increasing. Despite the still poor prognosis, standardised treatment has achieved improvements; nonetheless it is questionable whether all age groups have benefitted. Age and outcome need to be examined in a population-based setting.
Analyses included Munich Cancer Registry (MCR) data from 8601 invasive gastric cancer patients, diagnosed between 1998 and 2012. Tumour and therapy characteristics and outcome were analysed by two age groups (<70 vs. ≥70 years). Survival was analysed using the Kaplan-Meier method and relative survival was computed as an estimation for cancer-specific survival. Additional landmark analyses were conducted by calculating conditional survival of patients who survived more than 6 months.
Fifty-nine per cent of the cohort were ≥70 years old. These patients had tumours with a slightly better prognosis and were treated with less radical surgery and adjuvant therapy than younger patients. The 5-year relative survival was 40 % for the youngest (<50 years) and 23 % for the oldest patients (≥80 years). Survival differences were diminished or eliminated after landmark analyses: The 5-year relative survival in age groups 50-59, 60-69 and 70-79 years was comparable (between 48 and 49.6 %) and slightly worse in the youngest and oldest (45 %), which may be explained by more aggressive tumours and effects of cellular senescence, respectively.
The treatment and care of elderly gastric cancer patients in the MCR catchment area seems appropriate: if a patient's general condition allows oncologic resection and chemotherapy, it is conducted and the result is comparable between age groups.
[Show abstract][Hide abstract] ABSTRACT: To assess pancreatic fistula rate and secondary endpoints after pancreatogastrostomy (PG) versus pancreatojejunostomy (PJ) for reconstruction in pancreatoduodenectomy in the setting of a multicenter randomized controlled trial.
PJ and PG are established methods for reconstruction in pancreatoduodenectomy. Recent prospective trials suggest superiority of the PG regarding perioperative complications.
A multicenter prospective randomized controlled trial comparing PG with PJ was conducted involving 14 German high-volume academic centers for pancreatic surgery. The primary endpoint was clinically relevant postoperative pancreatic fistula. Secondary endpoints comprised perioperative outcome and pancreatic function and quality of life measured at 6 and 12 months of follow-up.
From May 2011 to December 2012, 440 patients were randomized, and 320 were included in the intention-to-treat analysis. There was no significant difference in the rate of grade B/C fistula after PG versus PJ (20% vs 22%, P = 0.617). The overall incidence of grade B/C fistula was 21%, and the in-hospital mortality was 6%. Multivariate analysis of the primary endpoint disclosed soft pancreatic texture (odds ratio: 2.1, P = 0.016) as the only independent risk factor. Compared with PJ, PG was associated with an increased rate of grade A/B bleeding events, perioperative stroke, less enzyme supplementation at 6 months, and improved results in some quality of life parameters.
The rate of grade B/C fistula after PG versus PJ was not different. There were more postoperative bleeding events with PG. Perioperative morbidity and mortality of pancreatoduodenectomy seem to be underestimated, even in the high-volume center setting.This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
Full-text · Article · Jul 2015 · Annals of surgery
[Show abstract][Hide abstract] ABSTRACT: Für viele Fragestellungen der patientenorientierten klinischen Forschung in der Chirurgie sind prospektiv randomisierte Multizenterstudien (mRCT) erforderlich, um mit der nötigen statistischen Trennschärfe eine valide Aussage zu treffen. Zur Durchführung solch hochwertiger Multizenterstudien ist ein Verbund von mehreren chirurgischen Studienzentren mit gut ausgebildetem Studienpersonal unabdingbar.
No preview · Article · Jun 2015 · Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen
[Show abstract][Hide abstract] ABSTRACT: Surgical site infections remain one of the most frequent complications following abdominal surgery and cause substantial costs, morbidity and mortality.
To assess the effectiveness of wound edge protectors in open abdominal surgery in reducing surgical site infections.
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.
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%).
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.
[Show abstract][Hide abstract] ABSTRACT: Continuous bleeding after using conventional hemostatic methods involving energy, sutures, or clips, is a serious and costly surgical complication. Many topical agents have been developed to promote intraoperative hemostasis, but improvement is needed in both decreasing time to hemostasis and increasing ease of use. Veriset™ hemostatic patch is CE-marked for controlling bleeding on the liver and in soft tissue. In the current study, we aimed to gather further evidence for the safety and effectiveness of Veriset™ hemostatic patch in soft tissue bleeding during a variety of surgical procedures.
Thirty patients scheduled for nonemergency surgery, each with an intraoperative soft tissue bleeding site, were treated with Veriset™ hemostatic patch. Time to hemostasis was monitored, and adverse events were assessed during the 90 days after surgery.
When Veriset™ hemostatic patch was used, hemostasis occurred within 5 minutes in 29/30 (96.7%) subjects and within 1 minute in 21/30 (70.0%) subjects. No device-related serious adverse events were recorded during the 30 days after surgery, and no reoperations for device-related bleeding complications were performed during the 5 days after surgery.
Veriset™ hemostatic patch is a safe and effective hemostat for controlling soft tissue bleeding during a variety of surgical procedures.
Full-text · Article · Mar 2015 · Medical Devices: Evidence and Research
[Show abstract][Hide abstract] ABSTRACT: Surgical site infection (SSI) remains to be one of the most frequent infectious complications following abdominal surgery. Prophylactic intra-operative wound irrigation (IOWI) before skin closure has been proposed to reduce bacterial wound contamination and the risk of SSI. However, current recommendations on its use are conflicting especially concerning antibiotic and antiseptic solutions because of their potential tissue toxicity and enhancement of bacterial drug resistances.
To analyze the existing evidence for the effect of IOWI with topical antibiotics, povidone-iodine (PVP-I) solutions or saline on the incidence of SSI following open abdominal surgery, a systematic review and meta-analysis of randomized controlled trials (RCTs) was carried out according to the recommendations of the Cochrane Collaboration.
Forty-one RCTs reporting primary data of over 9000 patients were analyzed. Meta-analysis on the effect of IOWI with any solution compared to no irrigation revealed a significant benefit in the reduction of SSI rates (OR = 0.54, 95 % confidence Interval (CI) [0.42; 0.69], p < 0.0001). Subgroup analyses showed that this effect was strongest in colorectal surgery and that IOWI with antibiotic solutions had a stronger effect than irrigation with PVP-I or saline. However, all of the included trials were at considerable risk of bias according to the quality assessment.
These results suggest that IOWI before skin closure represents a pragmatic and economical approach to reduce postoperative SSI after abdominal surgery and that antibiotic solutions seem to be more effective than PVP-I solutions or simple saline, and it might be worth to re-evaluate their use for specific indications.
Full-text · Article · Feb 2015 · Langenbeck s Archives of Surgery
[Show abstract][Hide abstract] ABSTRACT: The benefit assessment of surgical procedures serves as the basis for the concept of evidence-based surgery. However, especially in the field of surgery, many interventions are lacking assessment in high-quality clinical trials. Therefore, a well-structured benefit assessment of surgical interventions in the future is imperative. Considering the different perspectives, e.g. of the patients, surgeons, industry or health care investors, the implications of the benefits and risks of a procedure can differ significantly. Researchers have to abide by different regulations, depending on the type of intervention being evaluated in a surgical trial. Furthermore, the benefit assessment of surgical procedures poses specific challenges, from the choice of a relevant endpoint to issues concerning the standardization of the interventions and the impact of learning curves. The IDEAL concept, which was established by a group of international experts in 2009, serves as a framework for the future development and assessment of innovations in the field of surgery. For example, the SDGC (Study Center of the German Society of Surgery) and CHIR-Net (Surgical Studies Network) indicate that such collaborations of clinicians and methodologists can lead to the creation of a qualified structure for the effective benefit assessment of surgical procedures. In the future, the aforementioned evidence gaps must be eliminated and innovations evaluated efficiently by the work of such networks.
No preview · Article · Jan 2015 · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
[Show abstract][Hide abstract] ABSTRACT: Objective: To determine whether circular plastic wound edge protectors (CWEPs) significantly reduce the rate of surgical site infections (SSIs) in comparison to standard surgical towels in patients undergoing laparotomy. Background: SSIs cause substantial morbidity, prolonged hospitalization, and costs and remain one of themost frequent surgical complications. CWEPs have been proposed as a measure to reduce the incidence of SSIs. Methods: In this randomized controlled, multicenter, 2-arm, parallel-group design, patient-and observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels. Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a 30-day postoperative period. Results: Between September 2010 and November 2012, 608 patients undergoing laparotomy were randomized at 16 centers across Germany. Three patients in the device group and 11 patients in the control group did not undergo laparotomy. Patients' and procedural characteristics were well balanced between the 2 groups. Forty-eight patients discontinued the study prematurely, mainly because of relaparotomy (control, n = 9; intervention, n = 9) and death (control, n = 4; intervention, n = 7). A total of 79 patients experienced SSIs within 30 days of surgery, 27 of 274 (9.9%) in the device group and 52 of 272 (19.1%) in the control group (odds ratio = 0.462, 95% confidence interval: 0.281-0.762; P = 0.002). Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery, and in cleancontaminated/contaminated surgeries. Conclusions: Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery.
Full-text · Article · Nov 2014 · Annals of Surgery
[Show abstract][Hide abstract] ABSTRACT: Background:
Surgical treatment of incisional hernia includes implantation of a mesh. The use of synthetic grafts in contaminated fields results in an increased risk of infection. In these cases a potential advantage is described for biological repair material. Evidence for this problem is lacking; therefore, we initiated a survey among surgeons in Germany concerning this question.
Material and method:
A survey concerning indications, experience and techniques of using synthetic and biological meshes was sent to 60 surgical departments. The emphasis of the survey was on the differentiation of clean and contaminated fields.
The survey was answered by 42 %. The use of biological repair material was preferred in clean-contaminated, contaminated and soiled fields. Synthetic meshes were preferred in clean, rarely in clean-contaminated and not in contaminated or soiled situations. Primary suture repair was chosen in clean fields and barely in contaminated fields. For closure of giant hernias a component separation technique (CST) was favored by the majority of respondents. A single stage repair was preferred by most of the surgeons even in cases with simultaneous stoma takedown. A total of 72 % of the respondents were satisfied with the use of biological repair material, but the reimbursement was considered to be inappropriate.
Although the response rate was low, this survey gives an idea of the attitude towards the use of synthetic and biological meshes. Biological repair material is favored for hernia repair in contaminated or soiled fields. The advantage of this choice is a one stage repair despite the contamination. As the results of this survey are not able to provide arguments for the use of different meshes this question should be further investigated with a randomized controlled trial.
[Show abstract][Hide abstract] ABSTRACT: Background:
Despite improvements in liver surgery over the past decades, hemostasis during hepatic resections remains challenging. This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection.
Patients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat (COLL) or the carrier-bound fibrin sealant (CBFS) for secondary hemostasis. The primary endpoint was the proportion of patients with hemostasis after 3 min. Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min, the total time to hemostasis, and the complication rates during a 3 months follow-up period.
A total of 128 patients were included. In the COLL group, 53 out of 61 patients (86.9 %) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients (80.0 %) in the CBFS group. The 95 % confidence interval for this difference [-6.0 %, 19.8 %] does not include the lower noninferiority margin (-10 %). Thus, the COLL treatment can be regarded as noninferior to the comparator. The proportions of patients with hemostasis after 3, 5, and 10 min were not significantly different between the two study arms. Postoperative mortality and morbidity were similar in both treatment groups.
The collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate.
Full-text · Article · Jun 2014 · Langenbeck s Archives of Surgery
[Show abstract][Hide abstract] ABSTRACT: Gastric cancer accounts for 5 % of cancer deaths. Successful implementation of guideline-recommended treatment procedures should result in population-based outcome improvements despite the still poor prognosis. In this context, the objective of this study was to compare the outcome of gastric cancer by different levels of hospital care.
Total of 8,601 patients with invasive gastric cancer documented between 1998 and 2012 by the Munich Cancer Registry were evaluated. Tumour and therapy characteristics and outcome were analysed in regard to five levels of hospital care: three levels were defined for general hospitals (level I-III), while university hospitals and speciality hospitals were grouped as separate classes. Survival was investigated using the Kaplan-Meier-method, computing relative survival, and by multivariate Cox proportional hazard regression.
The average age differed between 66 years in university hospitals and 75 years in hospitals providing a basic level of care (level I). No survival differences were found for patients treated in different levels of hospital care in 75 % of the patient cohort, namely the M0 patients. A better survival could only be shown for patients with M1 at diagnosis when treated in a university or level III hospital compared to those treated in other hospitals.
The outcome difference of M1 patients is most likely caused by selection effects concerning health status differences and not by processes of health care attributable to level of hospital care. Thus, this study demonstrates and confirms appropriate treatment and care of gastric cancer over all levels of hospital care.
Full-text · Article · Mar 2014 · Journal of Cancer Research and Clinical Oncology
[Show abstract][Hide abstract] ABSTRACT: The purpose of this study was to report on the first experiences with freehand single-photon emission-computed tomography (freehand SPECT) in sentinel lymph node biopsy (SLNB) in patients with malignant melanoma. Freehand SPECT is a novel imaging modality combining gamma probes, surgical navigation systems, and emission tomography algorithms, designed to overcome some of the limitations of conventional gamma probes.
In this study 20 patients with malignant melanoma underwent conventional planar scintigraphy prior to surgery. In the operating room, the number and location of separable SLNs were detected first by a pre-incisional scan with freehand SPECT to render a 3D-image of the target site and afterwards by a scan with a conventional gamma probe. After SLNB another scan was performed to document the removal of all targeted SLNs.
Planar scintigraphy identified 40 SLNs in 26 nodal basins. Pre-incisional freehand SPECT mapped 38 of these nodes as well as one additional node in one patient (95.0% node based sensitivity). The results of freehand SPECT were identical to those of planar scintigraphy in 25 basins, while it missed one basin (96.2% basin based sensitivity). In comparison, the gamma probe failed to detect 7 nodes in 4 basins (82.5% node based sensitivity and 84.6% basin based sensitivity). After resection freehand SPECT detected 9 remaining radioactive spots, two of whichwere resected as they matched the position of SLNs detected on preoperative planar scintigraphy.
Freehand SPECT provides a real-time, intraoperative 3D-image of the radioactive labelled SLNs, facilitating their detection and resection.
No preview · Article · Sep 2013 · European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology
[Show abstract][Hide abstract] ABSTRACT: Bleeding during hepatic surgery is associated with prolonged hospitalization and increased morbidity and mortality. The Veriset™ haemostatic patch is a topical haemostat comprised of an absorbable backing made of oxidized cellulose and self-adhesive hydrogel components. It is designed to achieve haemostasis quickly and adhere to tissues without fixation.
A prospective, randomized, multicentre, single-blinded study (n = 50) was performed to compare the use of a Veriset™ haemostatic patch with a fibrin sealant patch (TachoSil®) (control) in the management of diffuse bleeding after hepatic surgery. Patients were randomized following the confirmation of diffuse bleeding requiring the use of a topical haemostat. Time to haemostasis was assessed at preset intervals until haemostasis was achieved.
Both groups were similar in comorbidities and procedural techniques. The median time to haemostasis in the group using the Veriset™ haemostatic patch was 1.0 min compared with 3.0 min in the control group (P < 0.001; 3-min minimum application time for the control patch). This result was independent of bleeding severity and surface area. Both products had similar safety profiles and no statistical differences were observed in the occurrence of adverse or device-related events.
Regardless of bleeding severity or surface area, the Veriset™ haemostatic patch achieved haemostasis in this setting significantly faster than the control device in patients undergoing hepatic resection. It was safe and easy to handle in open hepatic surgery.
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVES:: The objective of the HASTA trial was to compare hand suture versus stapling loop ileostomy closure in a randomized controlled trial. BACKGROUND:: Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy after low anterior resection. The best surgical technique for closure of loop ileostomy has not been defined yet. METHODS:: HASTA trial is a multicenter pragmatic randomized controlled surgical trial with 2 parallel groups to compare hand suture versus stapling for closure of loop ileostomy. The primary endpoint was the rate of bowel obstruction within 30 days after ileostomy closure. RESULTS:: A total of 337 randomized patients undergoing closure of loop ileostomy after low anterior resection because of rectal cancer in 27 centers were included. The overall rate of postoperative ileus after ileostomy closure was 13.4%. Seventeen of 165 (10.3%) patients in the stapler group and 27 of 163 (16.6%) in the hand suture group developed bowel obstruction within 30 days postoperatively [odds ratio (OR) = 1.72; 95% confidence interval (CI): 0.89-3.31 = 0.10]. Duration of surgical intervention was significantly shorter in the stapler group (15 minutes; P < 0.001). Multivariable analysis of potential risk factors did not reveal any significant correlation with development of postoperative ileus. Rate of anastomotic leakage (stapler: 3.0%, hand suture: 1.8%, P = 0.48) did not differ significantly as well as all other secondary endpoints. CONCLUSIONS:: Hand-sewn anastomosis versus stapler ileo-ileostomy for ileostomy closure are equally effective in terms of postoperative bowel obstruction, with stapler anastomosis leading to a shorter operation time. Postoperative ileus after ileostomy reversal remains a relevant complication.
No preview · Article · Nov 2012 · Annals of surgery