Dissection with LigaSure Impact™ versus conventional resection in pylorus-preserving partial pancreatoduodenectomy (DISSECT): a single-institution randomized controlled trial.

PURPOSE: In partial pancreatoduodenectomy, appropriate effective hemostasis during dissection is of major importance for procedural flow, operation time, and postoperative outcome. As ligation, clipping, or suturing of blood vessels is time-consuming and numerous instrument changes are required, the primary aim of this randomized controlled trial was to assess whether LigaSure Impact™ exhibits benefits over named conventional dissection techniques in patients undergoing pylorus-preserving partial pancreatoduodenectomy. METHODS: This single-institution, randomized, superiority trial was performed between September 27, 2009, and February 24, 2012. Patients undergoing pylorus-preserving partial pancreatoduodenectomy were allocated to the study arms in a 1:1 ratio based on an unstratified block randomization with random block sizes to receive either dissection with LigaSure Impact™ or conventional dissection. The primary endpoint was operation time. Secondary endpoints included peri- and postoperative morbidity and mortality, intraoperative blood loss, and length of hospital stay. To observe a time reduction of 40 min, 51 patients per arm were required. The primary analysis was the intention to treat. RESULTS: The mean operation time did not differ between the Ligasure Impact™ (308 min; SD: 56 min; range: 155-455 min) and the conventional dissection (318 min; SD: 90 min, range: 175-550 min) (p = 0.531). Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay. CONCLUSIONS: The application of LigaSure Impact™ dissection in pylorus-preserving partial pancreatoduodenectomy does not increase effectiveness and safety of dissection. TRIAL REGISTRATION: DRKS00000166.

Network meta-analysis of topical haemostatic agents in thyroid surgery.

BACKGROUND: The objective of this study was to investigate the potential benefit of local haemostatic agents for the prevention of postoperative bleeding after thyroidectomy. METHODS: A systematic literature search was performed, and RCTs involving adult patients who underwent thyroid surgery using either active (AHA) or passive (PHA) haemostatic agents were included in the review. The main outcome was the rate of cervical haematoma that required reoperation. A Bayesian random-effects model was used for network meta-analysis with minimally informative prior distributions. RESULTS: Thirteen RCTs were included. The rate of cervical haematoma requiring reoperation ranged from 0 to 9·1 per cent, and was not reduced by haemostatic agents: AHA versus control (odds ratio (OR) 1·53, 95 per cent credibility interval 0·21 to 10·77); PHA versus control (OR 2·74, 0·41 to 16·62) and AHA versus PHA (OR 1·77, 0·12 to 25·06). No difference was observed in the time required for drain removal, duration of hospital stay, and the rate of postoperative hypocalcaemia or recurrent nerve palsy. AHA led to a significantly lower total postoperative blood loss and reduced operating time in comparison with both the control and PHA groups. CONCLUSION: The general use of local haemostatic agents has not been shown to reduce the rate of clinically relevant bleeding.

Randomized clinical trial of stapler hepatectomy versus LigaSure™ transection in elective hepatic resection.

BACKGROUND: Previous studies have demonstrated stapler hepatectomy and use of various energy devices to be safe alternatives to the clamp-crushing technique in elective hepatic resection. In this randomized trial, the effectiveness and safety of stapler hepatectomy were compared with those of parenchymal transection with the LigaSure™ vessel sealing system. METHOD: Patients scheduled for elective liver resection at two tertiary-care centres were randomized during surgery to stapler hepatectomy or transection with the LigaSure™ device. Total intraoperative blood loss was the primary efficacy endpoint. Transection time, duration of operation, perioperative complications and length of hospital stay were recorded as secondary endpoints. RESULTS: A total of 138 patients were analysed, 69 in the LigaSure™ and 69 in the stapler hepatectomy group. Baseline characteristics were well balanced between the groups. Mean intraoperative blood loss was significantly higher in the LigaSure™ group than the stapler hepatectomy group: 1101 (95 per cent c.i. 915 to 1287) versus 961 (752 to 1170) ml (P = 0·028). The parenchymal transection time was significantly shorter in the stapler group (P = 0·005), as was the total duration of operation (P = 0·027). Surgical morbidity did not differ between the groups, nor did the grade of complications. CONCLUSION: Stapler hepatectomy was associated with reduced blood loss and a shorter duration of operation than the LigaSure™ device for parenchymal transection in elective partial hepatectomy. Registration number: NCT01858987 (http://www.clinicaltrials.gov).

Prospective trial to evaluate the prognostic value of different nutritional assessment scores in pancreatic surgery (NURIMAS Pancreas).

BACKGROUND: Preoperative nutritional status has an impact on patients' clinical outcome. For pancreatic surgery, however, it is unclear which nutritional assessment scores adequately assess malnutrition associated with postoperative outcome. METHODS: Patients scheduled for elective pancreatic surgery at the University of Heidelberg were screened for eligibility. Twelve nutritional assessment scores were calculated before operation, and patients were categorized as either at risk or not at risk for malnutrition by each score. The postoperative course was monitored prospectively by assessors blinded to the nutritional status. The primary endpoint was major complications evaluated for each score in a multivariable analysis corrected for known risk factors in pancreatic surgery. RESULTS: Overall, 279 patients were analysed. A major complication occurred in 61 patients (21·9 per cent). The proportion of malnourished patients differed greatly among the scores, from 1·1 per cent (Nutritional Risk Index) to 79·6 per cent (Nutritional Risk Classification). In the multivariable analysis, only raised amylase level in drainage fluid on postoperative day 1 (odds ratio (OR) 4·91, 95 per cent c.i. 1·10 to 21·84; P = 0·037) and age (OR 1·05, 1·02 to 1·09; P = 0·005) were significantly associated with major complications; none of the scores was associated with, or predicted, postoperative complications. CONCLUSION: None of the nutritional assessment scores defined malnutrition relevant to complications after pancreatic surgery and these scores may thus be abandoned.

Meta-analysis of prophylactic abdominal drainage in pancreatic surgery.

BACKGROUND: Intra-abdominal drains are frequently used after pancreatic surgery whereas their benefit in other gastrointestinal operations has been questioned. The objective of this meta-analysis was to compare abdominal drainage with no drainage after pancreatic surgery. METHODS: PubMed, the Cochrane Library and Web of Science electronic databases were searched systematically to identify RCTs comparing abdominal drainage with no drainage after pancreatic surgery. Two independent reviewers critically appraised the studies and extracted data. Meta-analyses were performed using a random-effects model. Odds ratios (ORs) were calculated to aggregate dichotomous outcomes, and weighted mean differences for continuous outcomes. Summary effect measures were presented together with their 95 per cent confidence intervals. RESULTS: Some 711 patients from three RCTs were included. The 30-day mortality rate was 2·0 per cent in the drain group versus 3·4 per cent after no drainage (OR 0·68, 95 per cent c.i. 0·26 to 1·79; P = 0·43). The morbidity rate was 65·6 per cent in the drain group and 62·0 per cent in the no-drain group (OR 1·17, 0·86 to 1·60; P = 0·31). Clinically relevant pancreatic fistulas were seen in 11·5 per cent of patients in the drain group and 9·5 per cent in the no-drain group. Reinterventions, intra-abdominal abscesses and duration of hospital stay also showed no significant difference between the two groups. CONCLUSION: Pancreatic resection with, or without abdominal drainage results in similar rates of mortality, morbidity and reintervention.

Pancreatogastrostomy Versus Pancreatojejunostomy for RECOnstruction After PANCreatoduodenectomy (RECOPANC, DRKS 00000767): Perioperative and Long-term Results of a Multicenter Randomized Controlled Trial.

OBJECTIVES: 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. BACKGROUND: PJ and PG are established methods for reconstruction in pancreatoduodenectomy. Recent prospective trials suggest superiority of the PG regarding perioperative complications. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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

BACKGROUND: 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. METHODS: Randomized clinical trials (RCTs) and controlled clinical trials (CCTs) comparing outcomes of dual-loop reconstruction with isolated pancreaticojejunostomy and single-loop reconstruction were searched according to PRISMA guidelines. Random-effects meta-analyses were performed and the results presented as weighted risk ratios or mean differences with their corresponding 95 per cent c.i. RESULTS: Of 83 trials screened for eligibility, three RCTs and four CCTs including a total of 802 patients were finally included. Quantitative synthesis showed no significant statistical difference between the two procedures regarding postoperative pancreatic fistula, delayed gastric emptying, haemorrhage, intra-abdominal fluid collection or abscess, bile leakage, wound infection, pneumonia, overall morbidity, mortality, reinterventions, reoperations, perioperative blood loss and length of hospital stay. Duration of surgery was significantly longer in patients undergoing dual-loop reconstruction. CONCLUSION: Dual-loop (Roux-en-Y) reconstruction with isolated pancreaticojejunostomy after partial pancreaticoduodenectomy is not superior to single-loop reconstruction regarding pancreatic fistula rate or other relevant outcomes. Additional superiority trials are therefore not warranted, although a high-quality trial may be justified to prove equivalence or non-inferiority.

Incisional hernia rate 3 years after midline laparotomy.

BACKGROUND: Incisional hernia is the most frequent long-term complication after visceral surgery, with an incidence of between 9 and 20 per cent 1 year after operation. Most controlled studies provide only short-term follow-up, and the actual incidence remains unclear. This study evaluated the incidence of incisional hernia up to 3 years after midline laparotomy in two prospective trials. METHODS: Three-year follow-up data from the ISSAAC (prospective, multicentre, historically controlled) and INSECT (randomized, controlled, multicentre) trials focused on the rate of incisional hernia 1 and 3 years after surgery. Differences between the two groups were compared using t tests for continuous data and the χ2 test for categorical data. RESULTS: Analysis of 775 patients included in the two trials suggested that the incisional hernia rate increased significantly from 12.6 per cent at 1 year to 22.4 per cent 3 years after surgery (P < 0.001), a relative increase of more than 60 per cent. CONCLUSION: This follow-up of two trials demonstrated that 1 year of clinical follow-up for detection of incisional hernia is not sufficient; follow-up for at least 3 years should be mandatory in any study evaluating the rate of postoperative incisional hernia after midline laparotomy.

[Clinical trials in surgery. On the way towards evidence-based surgery]. / Klinische Studien in der Chirurgie. Auf dem Weg zur evidenzbasierten Chirurgie.

The Study Centre of the German Surgical Society (SDGC) aims at a sustainable support of clinical trials in surgery. The SDGC focuses especially on the development and conducting of clinical trials in university and non-academic hospitals. This article outlines current fields of action and future perspectives of the SDGC.

[Contribution of the Study Center of the German Surgical Society to evidence based surgery]. / Beitrag des Studienzentrums der Deutschen Gesellschaft für Chirurgie zur evidenzbasierten Chirurgie.

Since the Study Center of the German Surgical Society (SDGC) was established in 2003 it has been supporting surgeons to implement their ideas for multicenter randomized studies. Assistance is provided for development (sample size calculation, protocol, funding application) implementation (submission to ethics committee, data management, monitoring) and analysis (statistical analysis, publication) in close collaboration with biometricians and data managers. Currently more than 2,500 patients have been included in 11 trials. The most complex SDGC study (SYNCHRONOUS) so far with up to 80 participating centers has been activated in September 2011. Furthermore, there is an increasing relevance for systematic reviews and meta analyses with regard to the development of studies and aggregation of results. For this reason a systematic review working group was established within the SDGC. To date 13 publications have been completed and 8 more are underway.

Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol.

BACKGROUND: Sedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE) is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 guideline for sedation procedures in gastrointestinal endoscopy published in 2008 in Germany increases patient safety by standardization. These new regulations increase costs because of the need for more personnel and a prolonged discharge procedure after examinations with sedation. Many patients have difficulties to meet the discharge criteria regulated by the S3 guideline, e.g. the call for a second person to escort them home, to resign from driving and working for the rest of the day, resulting in a refusal of sedation. Therefore, we would like to examine if an acupuncture during elective, diagnostic EGDEs could increase the comfort of patients refusing systemic sedation. METHODS/DESIGN: A single-center, double blinded, placebo controlled superiority trial to compare the success rates of elective, diagnostic EGDEs with real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic EGDE who refuse a systemic sedation are eligible. 354 patients will be randomized. The primary endpoint is the rate of successful EGDEs with the randomized technique. INTERVENTION: Real or placebo acupuncture before and during EGDE. Duration of study: Approximately 24 months. DISCUSSION: Organisation/Responsibility The ACUPEND--Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Interdisciplinary Endoscopy Center (IEZ) of the University Hospital Heidelberg is responsible for design and conduct of the trial, including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI) and the Center of Clinical Trials (KSC) at the Department of General, Visceral and Transplantation Surgery, University of Heidelberg. TRIAL REGISTRATION: The trial is registered at Germanctr.de (DRKS00000164) on December 10th 2009. The first patient was randomized on February 2nd 2010.

[Evidence-based antibiotic prophylaxis in general and visceral surgery]. / Evidenzbasierte Antibiotikaprophylaxe in der Allgemein- und Viszeralchirurgie.

The use of prophylactic perioperative antibiotic therapy if indicated could successfully and safely prevent surgical wound infections. The current guidelines (S1) for prophylactic perioperative antibiotic therapy of the Study Group of the Scientific Medical Associations (AWMF) of 2004 was replaced by a recommendation of the study group of the Paul-Ehrlich-Gesellschaft for Chemotherapy (PEG) in 2010. This recommendation includes recent research data from 2000 to 2008. Indications and choice of antibiotic agent depend on specific risk factors of the patient and the operation performed. The aim of this article is to describe the current recommendations of the PEG for general and visceral surgery.

Randomized clinical trial of a modified Seldinger technique for open central venous cannulation for implantable access devices.

INTRODUCTION: Totally implantable access ports (TIAPs) are often used for patients who need permanent venous access. The primary success rate using direct open insertion is about 80 per cent, so rescue strategies are needed. This study compared the primary success rates of standard open insertion and a modified Seldinger technique. METHODS: This randomized trial recruited 164 patients scheduled for primary implantation of a TIAP and compared two interventions. The primary endpoint was the success rate of the implantation technique. RESULTS: The primary success rates were similar: 66 (80 per cent) of 82 patients who had standard open insertion versus 69 (84 per cent) of 82 patients undergoing the modified Seldinger method (P = 0.686). A logistic mixed regression analysis including treatment group, age, Karnofsky index, body mass index and surgeon's experience showed no advantage for the Seldinger method: odds ratio 1.30 (95 per cent confidence interval 0.62 to 2.70). TIAPs were eventually implanted successfully in 163 (99.4 per cent) of 164 patients. In 11 patients randomized to standard surgery, the Seldinger method was a successful rescue strategy. CONCLUSION: The primary success rate was similar for both open insertion methods. The modified Seldinger method is useful if standard open insertion fails. REGISTRATION NUMBER: ISRCTN 52368201 (http://www.controlled-trials.com).

Comparison of Venae Sectio vs. modified Seldinger Technique for totally implantable access ports; Portas-trial [ISRCTN:52368201].

BACKGROUND: The insertion of a Totally Implantable Access Port (TIAP) is a routinely employed technique in patients who need a safe and permanent venous access. The number of TIAP implantations is increasing constantly mainly due to advanced treatment options for malignant diseases. Therefore it is important to identify the implantation technique which has the optimal benefit/risk ratio for the patient. STUDY DESIGN: A single-centre, randomized, controlled superiority trial to compare two different TIAP implantation techniques. SAMPLE SIZE: 160 patients will be included and randomized intra-operatively. ELIGIBILITY CRITERIA: Age equal or older than 18 years, patients scheduled for primary elective implantation of a TIAP in local anaesthesia and a signed informed consent. Primary endpoint: Primary success rate of the randomized technique. INTERVENTION: Venae Sectio in combination with the Seldinger Technique (guide wire and a peel away sheath) will be used to place a TIAP. Reference treatment: Conventional Venae Sectio will be used with a direct insertion of the TIAP without guide wire or peel away sheath. Duration of study: Approximately 20 months. ORGANISATION/RESPONSIBILITY: The trial will be conducted in compliance with the protocol and in accordance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The trial will also be carried out in keeping with local and regulatory requirements. The Klinisches Studienzentrum Chirurgie (KSC)--Centre of Clinical Trials in Surgery at the Department of Surgery, University Hospital Heidelberg is responsible for planning and conduction of the trial. Documentation of patient's data will be accomplished via electronical Case Report Files (eCRF) with MACRO-Software by the KSC. Randomization, data management, monitoring and biometry are provided by the independent Koordinierungszentrum für Klinische Studien (KKS)--Coordination Centre for Clinical Trails at the University of Heidelberg.

Effects of the forearm support band on wrist extensor muscle fatigue.

STUDY DESIGN: A crossover experimental design with repeated measures. OBJECTIVE: To determine whether the forearm support band alters wrist extensor muscle fatigue. BACKGROUND: Fatigue of the wrist extensor muscles is thought to be a contributing factor in the development of lateral epicondylitis. The forearm support band is purported to reduce or prevent symptoms of lateral epicondylitis but the mechanism of action is unknown. METHODS AND MEASURES: Fifty unimpaired subjects (36 men, 14 women; mean age = 29 +/- 6 years) were tested with and without a forearm support band before and after a fatiguing bout of exercise. Peak wrist extension isometric force, peak isometric grip force, and median power spectral frequency for wrist extensor electromyographic activity were measured before and after exercise and with and without the forearm support band. A 2 x 2 repeated measures multivariate analysis of variance was used to analyze the data, followed by univariate analysis of variance and Tukey's multiple comparison tests. RESULTS: Peak wrist extension isometric force, peak grip isometric force, and median power spectral frequency were all reduced after exercise. However, there was a significant reduction in peak grip isometric force and peak wrist extension isometric force values for the with-forearm support band condition (grip force 28%, wrist extension force 26%) compared to the without-forearm support band condition (grip force 18%, wrist extension force 15%). CONCLUSIONS: Wearing the forearm support band increased the rate of fatigue in unimpaired individuals. Our findings do not support the premise that wearing the forearm support band reduces muscle fatigue in the wrist extensors.