Pascal Probst

Antibiotics Versus Surgical Therapy for Uncomplicated Appendicitis: Systematic Review and Meta-analysis of Controlled Trials (PROSPERO 2015: CRD42015016882).

Objective: The aim was to investigate available evidence regarding effectiveness and safety of surgical versus conservative treatment of acute appendicitis. Summary of Background Data: There is ongoing debate on the merits of surgical and conservative treatment for acute appendicitis. Methods: A systematic literature search (Cochrane Library, Medline, Embase) and hand search of retrieved reference lists up to January 2016 was conducted to identify randomized and nonrandomized studies. After critical appraisal, data were analyzed using a random-effects model in a Mantel-Haenszel test or inverse variance to calculate risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). Results: Four trials and four cohort studies (2551 patients) were included. We found that 26.5% of patients in the conservative group needed appendectomy within 1 year, resulting in treatment effectiveness of 72.6%, significantly lower than the 99.4% in the surgical group, (RR 0.75; 95% CI 0.7–0.79; P = 0.00001; I2 = 62%). Overall postoperative complications were comparable (RR 0.95; 95% CI 0.35–2.58; P = 0.91; I2 = 0%), whereas the rate of adverse events (RR 3.18; 95% CI 1.63–6.21; P = 0.0007; I2 = 1%) and the incidence of complicated appendicitis (RR 2.52; 95% CI 1.17–5.43; P = 0.02; I2 = 0%) were significantly higher in the antibiotic treatment group. Randomized trials showed significantly longer hospital stay in the antibiotic treatment group (RR 0.3 days; 95% CI 0.07–0.53; P = 0.009; I2 = 49%). Conclusions: Although antibiotics may prevent some patients from appendectomies, surgery represents the definitive, one-time only treatment with a well-known risk profile, whereas the long-term impact of antibiotic treatment on patient quality of life and health care costs is unknown. This systematic review and meta-analysis helps physicians and patients in choosing between treatment options depending on whether they are risk averse or risk takers.

Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study.

Background: Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. Methods: A systematic literature search (1985–2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A &khgr;2 test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. Results: A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04–5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non–industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60–10.88; P < 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13–15.68; P < 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P < 0.001). Conclusions: Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.

Meta-analysis of complication rates for single-loop versus dual-loop (Roux-en-Y) with isolated pancreaticojejunostomy reconstruction after pancreaticoduodenectomy

Postoperative pancreatic fistula is one of the most important and potentially severe complications after partial pancreaticoduodenectomy. In this context, the reduction of postoperative pancreatic fistula by means of a dual‐loop (Roux‐en‐Y) reconstruction with isolation of the pancreaticojejunostomy from biliary drainage has been evaluated in several studies. This systematic review and meta‐analysis summarizes evidence of effectiveness and safety of the isolation of the pancreaticojejunostomy compared with conventional single‐loop reconstruction.

Thirty years of disclosure of conflict of interest in surgery journals

BACKGROUND A conflict of interest (COI) creates the risk that a professional judgment will be unduly influenced by a secondary interest. In practice, the leading concern is the creation of bias by industry sponsorship. Several organizations for ethics in scientific publishing exist, and standardized disclosure forms have been developed. The aim of this study was to investigate the present status of the definition, management, and disclosure of COI in journals devoted to general and abdominal surgery. METHODS Information on publisher, definition of COI, whether COI disclosure was mandatory, publication of the disclosure statement with the article, and when publication of disclosure statements was introduced were gathered from instructions for authors and from journal editors and presented descriptively. The hypothesis that journals with a disclosure policy have greater impact factors was tested with a Wilcoxon rank-sum test. RESULTS A sample of 64 journals was investigated. In 8 journals (13%) disclosure was deemed unnecessary. In the remaining 56 journals (88%) disclosure of COI was mandatory and in 39 of these journals (61%) the COI statement was published with the article. Journals declaring COI disclosure as mandatory had a greater impact factor (0.626 vs 1.732; P = .006). CONCLUSION Transparency is critical to the reliability of evidence-based medicine. All efforts should be made to give the reader the maximum amount of information. We recommend that every surgeon maintain a standardized, up-to-date disclosure form.

Duodenum-preserving pancreatic head resection: 10-year follow-up of a randomized controlled trial comparing the Beger procedure with the Berne modification

BACKGROUND Since the introduction of the duodenum-preserving pancreatic head resection for operative treatment of chronic pancreatitis, various modifications of the original Beger procedure have emerged. A randomized controlled trial comparing the Beger procedure and the Berne modification indicated that the latter is an equivalent alternative, but a comparison of the long-term results of both procedures has not yet been published. METHODS Between December 2002 and January 2005, 65 patients were randomized intraoperatively to the Beger or the Berne procedure. For this 10-year follow-up, patients were contacted by phone and in writing to evaluate patient-relevant outcome parameters. Statistical analysis was made on an intention-to-treat basis. RESULTS Median follow-up was 129 (111-137) months. Forty of 65 patients were available for follow-up; 11 of the original study cohort had died, and 14 were otherwise lost to follow-up. Quality of life, pain, occupational disability, exocrine and endocrine pancreatic function, endoscopic interventions, and redo operations were comparable in both groups. More than half of the patients were completely free of pain, and the majority in both groups judged that the index operation had improved their quality of life. CONCLUSION Ten-year follow-up showed no differences in patient-relevant outcome parameters between the Beger and Berne procedures for treatment of chronic pancreatitis. Because short-term results have shown the Berne modification is superior in terms of operation time and duration of hospital stay, it should be preferred whenever possible, depending on the individual surgeons expertise and the intraoperative findings.

Sphincter of Oddi botulinum toxin injection to prevent pancreatic fistula after distal pancreatectomy

Background. Postoperative pancreatic fistula represents the most important complication after distal pancreatectomy. The aim of this study was to evaluate the use of a preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi to prevent postoperative pancreatic fistula (German Clinical Trials Register number: DRKS00007885). Methods. This was an investigator‐initiated, prospective clinical phase I/II trial with an exploratory study design. We included patients who underwent preoperative endoscopic sphincter botulinum toxin injection (100 units of Botox). End points were the feasibility, safety, and postoperative outcomes, including postoperative pancreatic fistula within 30 days after distal pancreatectomy. Botulinum toxin patients were compared with a control collective of patients undergoing distal pancreatectomy without botulinum toxin injection by case‐control matching in a 1:1 ratio. Results. Between February 2015 and February 2016, 29 patients were included. All patients underwent successful sphincter of Oddi botulinum toxin injection within a median of 6 (range 0–10) days before operation. One patient had an asymptomatic, self‐limiting (48 hours) increase in serum amylase and lipase after injection. Distal pancreatectomy was performed in 24/29 patients; 5 patients were not resectable. Of the patients receiving botulinum toxin, 7 (29%) had increased amylase levels in drainage fluid on postoperative day 3 (the International Study Group of Pancreatic Surgery definition of postoperative pancreatic fistula grade A) without symptoms or need for reintervention. Importantly, no clinically relevant fistulas (International Study Group of Pancreatic Surgery grades B/C) were observed in botulinum toxin patients compared to 33% postoperative pancreatic fistula grade B/C in case‐control patients (P < .004). Conclusion. Preoperative sphincter of Oddi botulinum toxin injection is a novel and safe approach to decrease the incidence of clinically relevant postoperative pancreatic fistula after distal pancreatectomy. The results of the present trial suggest its efficacy in the prevention of clinically relevant postoperative pancreatic fistula and are validated currently in the German Federal Government–sponsored, multicenter, randomized controlled PREBOT trial.

Percutaneous versus surgical strategy for tracheostomy: protocol for a systematic review and meta-analysis of perioperative and postoperative complications

BackgroundTracheostomy is one of the most frequently performed procedures in intensive care medicine. The two main approaches to form a tracheostoma are the open surgical tracheotomy (ST) and the interventional strategy of percutaneous dilatational tracheotomy (PDT). It is particularly important to the critically ill patients that both procedures are performed with high success rates and low complication frequencies. Therefore, the aim of this systematic review is to summarize and analyze existing and relevant evidence for peri- and postoperative parameters of safety.Methods/designA systematic literature search will be conducted in The Cochrane Library, MEDLINE, LILACS, and Embase to identify all randomized controlled trials (RCTs) comparing peri- and postoperative complications between the two strategies and to define the strategy with the lower risk of potentially life-threatening events. A priori defined data will be extracted from included studies, and methodological quality will be assessed according to the recommendations of the Cochrane Collaboration.DiscussionThe findings of this systematic review with proportional meta-analysis will help to identify the strategy with the lowest frequency of potentially life-threatening events. This may influence daily practice, and the data may be implemented in treatment guidelines or serve as the basis for planning further randomized controlled trials. Considering the critical health of these patients, they will particularly benefit from evidence-based treatment.Systematic review registrationPROSPERO CRD42015021967

Prophylactic mesh placement for the PREvention of paraSTOmal hernias: The PRESTO systematic review and meta-analysis

Background Parastomal hernia (PH) is the most common complication after ostomy formation. Prophylactic mesh placement may be effective in reducing the rate of PH at the stoma site. The aims of this systematic review were to summarize the evidence with regard to the safety and effectiveness in comparison with the standard procedure without mesh placement and to identify important risk constellations. Method A systematic literature search was performed in PubMed, EMBASE and the Cochrane library with no language or date restrictions. Randomized (RCTs) and non-randomized controlled trials (nRCTs) were included. The main outcomes of interest were PH (primary outcome) rate and stoma-related complications (secondary outcomes) such as stenosis or fistula. Statistical analysis included meta-analyses of pooled data and subgroup analyses. Results Eleven trials (eight RCTs; three nRCTs) with a total of 755 patients were included. PH rate varied from 0% to 59% in the intervention and from 20% to 94% in the control group. RCTs showed a significant reduction of PH rate in the mesh group (OR 0.24; 95% CI 0.10 to 0.58, p = 0.034), whereas included nRCTs did not. No significant differences were observed in postoperative complication rates. Subgroup analyses showed superiority of non-absorbable meshes and sublay mesh positioning in open surgery. Conclusion Prophylactic mesh placement is safe and reduces PH rate. A recommendation for prophylactic non-absorbable meshes in a sublay position can be made for patients undergoing open colorectal operations with end-ostomies. Further research endeavors should focus on patient-oriented outcomes, not only PH rate, with respect to tailored treatment in specific patient populations.

Early combined parenteral and enteral nutrition for pancreaticoduodenectomy - Retrospective cohort analysis.

Background Suggested guidelines for nutritional support after pancreaticoduodenectomy are still controversial. Recent evidence suggests that combining enteral nutrition (EN) with parenteral nutrition (PN) improves outcome. For ten years, patients have been treated with Early Combined Parenteral and Enteral Nutrition (ECPEN) after PD. The aim of this study was to report on rationale, safety, effectiveness and outcome associated with this method. Methods Consecutive PD performed between 2003 and 2012 were analyzed retrospectively. Early EN and PN was standardized and started immediately after surgery. EN was increased to 40 ml/h (1 kcal/ml) over 24 h, while PN was supplemented based on a daily energy target of 25 kcal/kg. Standard enteral and parenteral products were used. Results Sixty-nine patients were nutritionally supplemented according to ECPEN. The median coverage of kcal per patients related to the total caloric requirements during the entire hospitalization (nutrition balance) was 93.4% (range: 100%–69.3%). The nutritional balance in patients with needle catheter jejunostomy (NCJ) was significantly higher than in the group with nasojejunal tube (97.1% vs. 91.6%; p < 0.0001). Mortality rate was 5.8%, while major complications (Clavien-Dindo 3–5) occurred in 21.7% of patients. Neither the presence of preoperative malnutrition nor the application of preoperative immunonutrition was associated with postoperative clinical outcome. Conclusion This is the first European study of ECPEN after PD. ECPEN is safe and, especially in combination with NCJ, provides comprehensive coverage of caloric requirements during the postoperative phase. Clinical controlled trials are needed to investigate potential benefits of complete energy supplementation during the early postoperative phase after PD.

Systematic review and meta-analysis of postcarotid endarterectomy hypertension after eversion versus conventional carotid endarterectomy

Objective: Blood pressure (BP) instability after carotid endarterectomy (CEA) is a risk factor for cerebrovascular and cardiovascular complications. The role of the operative technique in the development of post‐CEA hemodynamic instability is unclear. The primary goal of this study was to systematically review the literature to determine whether hypertension in the early postoperative period is dependent on the surgical technique used. Methods: We searched MEDLINE, Cochrane CENTRAL, and Web of Science through June 2016 without restrictions to language or starting date. The interventions of interest were eversion CEA (E‐CEA) compared with conventional CEA (C‐CEA) with or without patch plasty. The primary outcome of interest was the incidence of postoperative need for vasodilator therapy because of hypertension in the early postoperative period, the duration of which was predefined in the individual studies. Secondary outcomes were the intergroup mean difference of the mean within‐group changes of postoperative (24 hours) to baseline systolic BP, the incidence of hypotension requiring vasopressor therapy, and the rate of complications. The odds ratio (OR) of each binary outcome was pooled across studies with its 95% confidence interval (CI). For meta‐analysis of continuous outcomes, the weighted mean differences with the corresponding 95% CIs were pooled. Strength of evidence of the outcomes was judged according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines. Results: We identified six studies, of which four were nonrandomized prospective and two retrospective with low to moderate risk of bias. In addition, results of a post hoc analyses of a randomized controlled trial were included, resulting in a total number of seven included studies. Duration of the postoperative study period ranged from 1 to 6 days. The meta‐analysis of all studies regarding the primary outcome demonstrated increased rates of post‐CEA hypertension after E‐CEA (pooled OR, 2.75; 95% CI, 1.82–4.16; I2 = 49.9%). The pooled weighted intergroup mean difference between the E‐CEA and C‐CEA effects on postoperative systolic BP was +12.92 mm Hg (95% CI, 8.06–17.78; I2 = 93.6%; P < .0001). Hypotension was significantly higher in the C‐CEA group (pooled OR, 11.37; 95% CI, 1.95–66.46; I2 = 0%). There was no difference in postoperative complications including myocardial infarction, stroke, neck hematoma, or death. Strength of evidence contributing to the primary outcome as well as the hypotension outcome was graded as moderate and that contributing to the other secondary outcomes was graded as very low. Conclusions: E‐CEA increases the risk for post‐CEA hypertension, whereas C‐CEA is more often associated with hypotension, Careful BP monitoring at least in the early postoperative period after CEA is mandatory, especially when the eversion technique is used.