Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicentre Randomized Controlled PORTAS-3 Trial (DRKS 00004900).

OBJECTIVES: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. BACKGROUND DATA: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. METHODS: PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint. RESULTS: Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups. CONCLUSION: A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts. TRIAL REGISTRATION: German Clinical Trials Register DRKS 00004900.

Glycine Protects the Liver from Reperfusion Injury following Pneumoperitoneum.

BACKGROUND: Experimental pneumoperitoneum induces ischemia/reperfusion injury (IRI) in the liver, most likely via Kupffer cell (KC)-dependent mechanisms. Glycine has been shown to ameliorate IRI in various animal models. Thus, this study was performed to assess the effects of glycine on the liver after pneumoperitoneum. MATERIALS AND METHODS: Sprague-Dawley rats (220-250 g in weight) underwent CO2 pneumoperitoneum (12 mm Hg) for 90 min. Some rats received i.v. glycine (1.5 mL, 300 mM) 10 min before pneumoperitoneum. Controls were given the same volume of Ringer's solution. Transaminases, hepatic microcirculation, and phagocytosis of latex beads indexing both liver injury and KC activation were examined following pneumoperitoneum. Analysis of variance (ANOVA), plus a subsequent t test or χ2 test (or Fisher's exact test) were carried out as appropriate. Results are presented as mean ± SEM. RESULTS: Glycine significantly decreased lactate dehydrogenase at 1 h and both aspartate aminotransferase and alanine aminotransferase at 2 h after pneumoperitoneum from 477 ± 43, 154 ± 17, and 60 ± 6 U/L in controls to 348 ± 25, 101 ± 11, and 34 ± 3 U/L, respectively (p < 0.05). In parallel, glycine significantly decreased both the rate of permanent adherence of leukocytes to the endothelium by up to 35% and the rate of phagocytosis by > 50% compared to the control group. CONCLUSION: Glycine decreased IRI after pneumoperitoneum, most likely via KC-dependent mechanisms.

Computer tomographic analysis of organ motion caused by respiration and intraoperative pneumoperitoneum in a porcine model for navigated minimally invasive esophagectomy.

BACKGROUND: Navigation systems have the potential to facilitate intraoperative orientation and recognition of anatomical structures. Intraoperative accuracy of navigation in thoracoabdominal surgery depends on soft tissue deformation. We evaluated esophageal motion caused by respiration and pneumoperitoneum in a porcine model for minimally invasive esophagectomy. METHODS: In ten pigs (20-34 kg) under general anesthesia, gastroscopic hemoclips were applied to the cervical (CE), high (T1), middle (T2), and lower thoracic (T3) level, and to the gastroesophageal junction (GEJ) of the esophagus. Furthermore, skin markers were applied. Three-dimensional (3D) and four-dimensional (4D) computed tomography (CT) scans were acquired before and after creation of pneumoperitoneum. Marker positions and lung volumes were analyzed with open source image segmentation software. RESULTS: Respiratory motion of the esophagus was higher at T3 (7.0 ± 3.3 mm, mean ± SD) and GEJ (6.9 ± 2.8 mm) than on T2 (4.5 ± 1.8 mm), T1 (3.1 ± 1.8 mm), and CE (1.3 ± 1.1 mm). There was significant motion correlation in between the esophageal levels. T1 motion correlated with all other esophagus levels (r = 0.51, p = 0.003). Esophageal motion correlated with ventilation volume (419 ± 148 ml) on T1 (r = 0.29), T2 (r = 0.44), T3 (r = 0.54), and GEJ (r = 0.58) but not on CE (r = - 0.04). Motion correlation of the esophagus with skin markers was moderate to high for T1, T2, T3, GEJ, but not evident for CE. Pneumoperitoneum led to considerable displacement of the esophagus (8.2 ± 3.4 mm) and had a level-specific influence on respiratory motion. CONCLUSIONS: The position and motion of the esophagus was considerably influenced by respiration and creation of pneumoperitoneum. Esophageal motion correlated with respiration and skin motion. Possible compensation mechanisms for soft tissue deformation were successfully identified. The porcine model is similar to humans for respiratory esophageal motion and can thus help to develop navigation systems with compensation for soft tissue deformation.

Reversible biliary occlusion in a small animal model: first description of a new technique.

BACKGROUND: Experimental models with reversible biliary occlusion resulted in a high mortality of the animals, up to 20-60% according to the literature. Our aim was to assess a safe and valid technique for reversible biliary occlusion with a low mortality. METHODS: We randomized 30 rats into two groups: with bile duct occlusion (BDO, n=18) and with sham manipulation of the extrahepatic bile duct (control, n=12). We used a removable vascular clip for temporary occlusion of the extrahepatic bile duct. The clip was removed on postoperative day (POD) 2. On POD 2, 3, and 5, we measured the hepatocellular injury and metabolic function markers in serum. Activation of mononuclear cells (HIS36) and expression of regeneration markers [cytokeratin 19, hepatic growth factor (HGF)-α, and HGF-ß] were determined by immunohistochemistry. RESULTS: The survival rate was 96.67% (1/30); one animal died. The mortality in the BDO group was 6% (1/18) and that in the control group was 0% (0/12). BDO resulted in a sharp increase of hepatocellular injury and cholestatic parameters on POD 2 with a rapid decline till POD 3. Significantly strongest activation of Kupffer cells and expression of proliferation markers were found until POD 5 after BDO. CONCLUSION: The clip technique is a safe, cheap, and valid method for reversible biliary occlusion with an extremely low mortality.

Correction: Use of Mesh in Laparoscopic Paraesophageal Hernia Repair: A Meta-Analysis and Risk-Benefit Analysis.

[This corrects the article DOI: 10.1371/journal.pone.0139547.].

Laparoscopic Mesh-augmented Hiatoplasty With Cardiophrenicopexy Versus Laparoscopic Nissen Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Double-center Randomized Controlled Trial.

OBJECTIVE: Laparoscopic mesh-augmented hiatoplasty with cardiophrenicopexy (LMAH-C) might represent an alternative treatment of gastroesophageal reflux disease (GERD) and may provide durable reflux control without fundoplication. The expected benefit is the prevention of fundoplication-related side effects. Aim of the present trial was to compare LMAH-C with laparoscopic Nissen fundoplication (LNF) in patients with GERD. METHODS: In a double-center randomized controlled trial (RCT) patients with proven GERD were eligible and assigned by central randomization to either LMAH-C (n = 46) or LNF (n = 44). The indigestion subscore of the Gastrointestinal Symptom Rating Scale questionnaire (GSRS) indicating gas-related symptoms as possible side effects of LNF was the primary endpoint. Secondary endpoints comprised pH testing and endoscopy and other symptoms measured by the GSRS, dysphagia, and the Gastrointestinal Quality of Life Index. The follow-up period was 36 months. RESULTS: Indigestion subscore (LMAH-C 2.9 ±â€Š1.5 vs LNF 3.7 ±â€Š1.6; P = 0.031) but not dysphagia (2.8 ±â€Š1.9 vs 2.3 ±â€Š1.7; P = 0.302) and quality of life (106.9 ±â€Š25.5 vs 105.8 ±â€Š24.9; P = 0.838) differed between the groups at 36 months postoperatively. Although the reflux subscore improved in both groups, it was worse in LMAH-C patients (2.5 ±â€Š1.6 vs 1.6 ±â€Š1.0; P = 0.004) corresponding to a treatment failure of 77.3% in LMAH-C patients and of 34.1% in LNF patients (P < 0.001). CONCLUSIONS: LNF is more effective in the treatment of GERD than LMAH-C. Procedure-related side effects seem to exist but do not affect the quality of life. Laparoscopic fundoplication therefore remains the standard surgical treatment for GERD.

Use of Mesh in Laparoscopic Paraesophageal Hernia Repair: A Meta-Analysis and Risk-Benefit Analysis.

INTRODUCTION: Mesh augmentation seems to reduce recurrences following laparoscopic paraesophageal hernia repair (LPHR). However, there is an uncertain risk of mesh-associated complications. Risk-benefit analysis might solve the dilemma. MATERIALS AND METHODS: A systematic literature search was performed to identify randomized controlled trials (RCTs) and observational clinical studies (OCSs) comparing laparoscopic mesh-augmented hiatoplasty (LMAH) with laparoscopic mesh-free hiatoplasty (LH) with regard to recurrences and complications. Random effects meta-analyses were performed to determine potential benefits of LMAH. All data regarding LMAH were used to estimate risk of mesh-associated complications. Risk-benefit analysis was performed using a Markov Monte Carlo decision-analytic model. RESULTS: Meta-analysis of 3 RCTs and 9 OCSs including 915 patients revealed a significantly lower recurrence rate for LMAH compared to LH (pooled proportions, 12.1% vs. 20.5%; odds ratio (OR), 0.55; 95% confidence interval (CI), 0.34 to 0.89; p = 0.04). Complication rates were comparable in both groups (pooled proportions, 15.3% vs. 14.2%; OR, 1.02; 95% CI, 0.63 to 1.65; p = 0.94). The systematic review of LMAH data yielded a mesh-associated complication rate of 1.9% (41/2121; 95% CI, 1.3% to 2.5%) for those series reporting at least one mesh-associated complication. The Markov Monte Carlo decision-analytic model revealed a procedure-related mortality rate of 1.6% for LMAH and 1.8% for LH. CONCLUSIONS: Mesh application should be considered for LPHR because it reduces recurrences at least in the mid-term. Overall procedure-related complications and mortality seem to not be increased despite of potential mesh-associated complications.

The TICAP-Study (titanium clips for appendicular stump closure): A prospective multicentre observational study on appendicular stump closure with an innovative titanium clip.

BACKGROUND: To evaluate the effectiveness and safety of the DS Titanium Ligation Clip for appendicular stump closure in laparoscopic appendectomy. METHODS: Overall, 502 patients undergoing laparoscopic appendectomy were recruited for this observational multicentre study in nine study centres between October 2011 and July 2013. The clip was finally applied in 390 patients. Primary outcome variables were feasibility of the clip, intra-abdominal surgical site (abscesses, stump leakages) and superficial wound infections. Patients were followed 30 days after surgery. RESULTS: The clip was applicable in nearly 80 % of patients. Reasons for not applying the clip were mainly an inflamed caecum or a too large diameter of the appendix base. Superficial wound infections were found in nine (2.31 %), intra-abdominal abscesses in five (1.28 %), appendicular stump leak in one (0.26 %), and other adverse events in 22 (5.64 %) patients. In total, 12 (3.08 %) patients were re-admitted to hospital for treatment. Seven re-admissions were surgery-related; ten (2.56 %) patients had to be re-operated. One patient died during the course of the study due to persisting peritonitis (mortality 0.26 %). CONCLUSIONS: The results suggest that the DS Titanium Ligation Clip is a safe and effective option in securing the appendicular stump in laparoscopic appendectomy. The complication rates found with the use of the DS-Clip are comparable to the rates in the literature when other methods are used. TRIAL REGISTRATION: NCT01734837 .

Repair of Paraesophageal Hiatal Hernias­Is a Fundoplication Needed? A Randomized Controlled Pilot Trial.

BACKGROUND: The need for a fundoplication during repair of paraesophageal hiatal hernias (PEH) remains unclear. Prevention of gastroesophageal reflux represents a trade-off against the risk of fundoplication-related side effects. The aim of this trial was to compare laparoscopic mesh-augmented hiatoplasty with simple cardiophrenicopexy (LMAH-C) with laparoscopic mesh-augmented hiatoplasty with fundoplication (LMAH-F) in patients with PEH. STUDY DESIGN: The study was designed as a patient- and assessor-blinded randomized controlled pilot trial, registration number: DRKS00004492 (www.germanctr.de/). Patients with symptomatic PEH were eligible and assigned by central randomization to LMAH-C or LMAH-F. Endpoints were postoperative gastroesophageal reflux, complications, and quality of life 12 months postoperatively. RESULTS: Forty patients (9 male, 31 female) were randomized. Patients were well matched for baseline characteristics. At 3 months, the DeMeester score was higher after LMAH-C compared with LMAH-F (40.9 ± 39.9 vs. 9.6 ± 17; p = 0.048). At 12 months, the reflux syndrome score was higher after LMAH-C compared with LMAH-F (1.9 ± 1.2 vs. 1.1 ± 0.4; p = 0.020). In 53% of LMAH-C patients and 17% of LMAH-F patients, postoperative esophagitis was present (p = 0.026). Values of dysphagia (2.1 ± 1.6 vs 1.9 ± 1.4; p = 0.737), gas bloating (2.6 ± 1.4 vs 2.8 ± 1.4; p = 0.782), and quality of life (116.0 ± 16.2 vs 115.9 ± 15.8; p = 0.992) were similar. Relevant postoperative complications occurred in 4 (10%) patients and did not differ between the groups. CONCLUSIONS: Laparoscopic repair of PEH should be combined with a fundoplication to avoid postoperative gastroesophageal reflux and resulting esophagitis. Fundoplication-related side effects do not appear to be clinically relevant. Multicenter randomized trials are required to confirm these findings.

Laparoscopic mesh-augmented hiatoplasty without fundoplication as a method to treat large hiatal hernias.

PURPOSE: Laparoscopic hiatal hernia repair with additional fundoplication is a commonly recommended standard surgical treatment for symptomatic large hiatal hernias with paraesophageal involvement (PEH). However, due to the risk of persistent side effects, this method remains controversial. Laparoscopic mesh-augmented hiatoplasty without fundoplication (LMAH), which combines hiatal repair and mesh reinforcement, might therefore be an alternative. METHODS: In this retrospective study of 55 (25 male, 30 female) consecutive PEH patients, the perioperative course and symptomatic outcomes were analyzed after a mean follow-up of 72 months. RESULTS: The mean DeMeester symptom score decreased from 5.1 to 1.8 (P < 0.001) and the gas bloating value decreased from 1.2 to 0.5 (P = 0.001). The dysphagia value was 0.7 before surgery and 0.6 (P = 0.379) after surgery. The majority of the patients were able to belch and vomit (96 and 92 %, respectively). Acid-suppressive therapy on a regular basis was discontinued in 68 % of patients. In 4 % of patients, reoperation was necessary due to recurrent or persistent reflux. A mesh-related stenosis that required endoscopic dilatation occurred in 2 % of patients. CONCLUSIONS: LMAH is feasible, safe and provides an anti-reflux effect, even without fundoplication. As operation-related side effects seem to be rare, LMAH is a potential treatment option for large hiatal hernias with paraesophageal involvement.

Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304).

OBJECTIVE: Acute cholecystitis is a common disease, and laparoscopic surgery is the standard of care. BACKGROUND: Optimal timing of surgery for acute cholecystitis remains controversial: either early surgery shortly after hospital admission or delayed elective surgery after a conservative treatment with antibiotics. METHODS: The ACDC ("Acute Cholecystitis-early laparoscopic surgery versus antibiotic therapy and Delayed elective Cholecystectomy") study is a randomized, prospective, open-label, parallel group trial. Patients were randomly assigned to receive immediate surgery within 24 hours of hospital admission (group ILC) or initial antibiotic treatment, followed by delayed laparoscopic cholecystectomy at days 7 to 45 (group DLC). For infection, all patients were treated with moxifloxacin for at least 48 hours. Primary endpoint was occurrence of predefined relevant morbidity within 75 days. Secondary endpoints were as follows: (1) 75-day morbidity using a scoring system; (2) conversion rate; (3) change of antibiotic therapy; (4) mortality; (5) costs; and (6) length of hospital stay. RESULTS: Morbidity rate was significantly lower in group ILC (304 patients) than in group DLC (314 patients): 11.8% versus 34.4%. Conversion rate to open surgery and mortality did not differ significantly between groups. Mean length of hospital stay (5.4 days vs 10.0 days; P < 0.001) and total hospital costs (€2919 vs €4262; P < 0.001) were significantly lower in group ILC. CONCLUSIONS: In this large, randomized trial, laparoscopic cholecystectomy within 24 hours of hospital admission was shown to be superior to the conservative approach concerning morbidity and costs. Therefore, we believe that immediate laparoscopic cholecystectomy should become therapy of choice for acute cholecystitis in operable patients. (NCT00447304).

Navigation system for minimally invasive esophagectomy: experimental study in a porcine model.

BACKGROUND: Navigation systems potentially facilitate minimally invasive esophagectomy and improve patient outcome by improving intraoperative orientation, position estimation of instruments, and identification of lymph nodes and resection margins. The authors' self-developed navigation system is highly accurate in static environments. This study aimed to test the overall accuracy of the navigation system in a realistic operating room scenario and to identify the different sources of error altering accuracy. METHODS: To simulate a realistic environment, a porcine model (n = 5) was used with endoscopic clips in the esophagus as navigation targets. Computed tomography imaging was followed by image segmentation and target definition with the medical imaging interaction toolkit software. Optical tracking was used for registration and localization of animals and navigation instruments. Intraoperatively, the instrument was displayed relative to segmented organs in real time. The target registration error (TRE) of the navigation system was defined as the distance between the target and the navigation instrument tip. The TRE was measured on skin targets with the animal in the 0° supine and 25° anti-Trendelenburg position and on the esophagus during laparoscopic transhiatal preparation. RESULTS: On skin targets, the TRE was significantly higher in the 25° position, at 14.6 ± 2.7 mm, compared with the 0° position, at 3.2 ± 1.3 mm. The TRE on the esophagus was 11.2 ± 2.4 mm. The main source of error was soft tissue deformation caused by intraoperative positioning, pneumoperitoneum, surgical manipulation, and tissue dissection. CONCLUSION: The navigation system obtained acceptable accuracy with a minimally invasive transhiatal approach to the esophagus in a realistic experimental model. Thus the system has the potential to improve intraoperative orientation, identification of lymph nodes and adequate resection margins, and visualization of risk structures. Compensation methods for soft tissue deformation may lead to an even more accurate navigation system in the future.

Virtual reality does not meet expectations in a pilot study on multimodal laparoscopic surgery training.

BACKGROUND: The purpose of the present study was to determine the value of virtual reality (VR) training for a multimodality training program of basic laparoscopic surgery. MATERIALS AND METHODS: Participants in a two-day multimodality training for laparoscopic surgery used box trainers, live animal training, and cadaveric training on the pulsating organ perfusion (POP) trainer in a structured and standardized training program. The participants were divided into two groups. The VR group (n = 13) also practiced with VR training during the program, whereas the control group (n = 14) did not use VR training. The training modalities were assessed using questionnaires with a five-point Likert scale after the program. Concerning VR training, members of the control group assessed their expectations, whereas the VR group assessed the actual experience of using it. Skills performance was evaluated with five standardized test tasks in a live porcine model before (pre-test) and after (post-test) the training program. Laparoscopic skills were measured by task completion time and a general performance score for each task. Baseline tests were compared with laparoscopic experience of all participants for construct validity of the skills test. RESULTS: The expected benefit from VR training of the control group was higher than the experienced benefit of the VR group. Box and POP training received better ratings from the VR group than from the control group for some purposes. Both groups improved their skill parameters significantly from pre-training to post-training tests [score +17 % (P < 0.01), time -29 % (P < 0.01)]. No significant difference was found between the two groups for laparoscopic skills improvement except for the score in the instrument coordination task. Construct validity of the skills test was significant for both time and score. CONCLUSIONS: At its current level of performance, VR training does not meet expectations. No additional benefit was observed from VR training in our multimodality training program.

Challenges and pitfalls of experimental bariatric procedures in rats.

INTRODUCTION: The impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) on obesity and obesity-related diseases is unquestionable. Up to now, the technical descriptions of these techniques in animals/rats have not been very comprehensive. METHODS: For SG and RYGB, operating time, learning curve, and intraoperative mortality in relation to weight of the rat and type of anesthesia were recorded. Furthermore, a review of the literature on experimental approaches towards SG and RYGB in rats was carried out, merging in a detailed technical description for both procedures. RESULTS: The data presented here revealed that the mean operating time for SG (69.4 ± 22.2 min (SD)) was shorter than for RYGB (123.0 ± 20.7 min). There is a learning curve for both procedures, resulting in a reduced operating time of up to 60% in SG and 35% in RYGB (p < 0.05; t-test). However, with increased weight, operating time increases to about 80 min for SG and about 120 min for RYGB. Obese rats have an increased intraoperative mortality rate of up to 50%. After gaseous anesthesia the mortality can be even higher. The literature search revealed 40 papers dealing with SG and RYGB in rats. 18 articles (45%) contained neither photographs nor illustrations; 14 articles (35%) did not mention the applied type of anesthesia. The mortality rate was described in 15 papers (37.5%). CONCLUSION: Experimental obesity surgery in rats is challenging. Because of the high mortality in obese rats operated under gaseous anesthesia, exercises to establish the techniques should be performed in small rats using intraperitoneal anesthesia.

Augmented reality visualization during laparoscopic radical prostatectomy.

PURPOSE: We present an augmented reality (AR) navigation system that conveys virtual organ models generated from transrectal ultrasonography (TRUS) onto a real laparoscopic video during radical prostatectomy. By providing this additional information about the actual anatomy, we can support surgeons in their working decisions. This work reports the system's first in-vivo application. MATERIALS AND METHODS: The system uses custom-developed needles with colored heads that are inserted into the prostate as soon as the organ surface is uncovered. These navigation aids are once segmented in three-dimensional (3D) TRUS data that is acquired right after the placement of the needles and then continuously tracked in the laparoscopic video images by the surgical navigation system. The navigation system traces the navigation aids in real time and computes a registration between TRUS image and laparoscopic video based on the two-dimensional-three dimensional (2D-3D) point correspondences. With this registration, the system correctly superimposes TRUS-based 3D information on an additional AR monitor placed next to the normal laparoscopic screen. Surgical navigation guidance took place until the prostate was removed from the rectal wall. Finally, the navigation aids were removed together with the specimen inside the specimen bag. RESULTS: The initial human in-vivo application of the surgical navigation system was successful. No complications occurred, the prostate was removed together with the navigation aids, and the system supported the surgeons as intended with an AR visualization in real time. In case of tissue deformations, changes in the spatial configuration of the navigation aids are detected, which preserves the system from erroneous navigation visualization. CONCLUSIONS: Feasibility of the navigation system was shown in the first in-vivo application. TRUS information could be superimposed via AR in real time. To show the benefit for the patient, results obtained from a larger number of trials are needed.

LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial.

BACKGROUND: The pp-Whipple procedure requires extensive preparation. The conventional preparation technique is done with scissors for dissection and ligatures, and with clips and sutures for hemostasis. This procedure is very time-consuming and requires numerous changes of instruments. The LigaSure™ device allows dissection and hemostasis for preparation with one instrument. Up to now there has been no comparison of the two techniques with regard to operating time and the patients' outcome. It is still unclear which technique has the optimal benefit/risk ratio for the patient. METHODS/DESIGN: A single-center, randomized, single-blinded, controlled superiority trial to compare two different techniques for dissection in a pp-Whipple procedure. 102 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective pp-Whipple procedure who signed the informed consent will be included. The primary endpoint is the operating time of the randomized technique. Control Intervention: Conventional dissection technique; experimental intervention: LigaSureTM dissection technique. Duration of study: Approximately 15 months; follow up time: 3 years. The trial is registered at German ClinicalTrials Register (DRKS00000166).

Comparison of different surgical techniques in distal pancreatectomy: an experimental study in a porcine model.

AIMS: Different surgical transection methods have been used for distal pancreatectomy (DP), but none of them has yet achieved perfect results. This study compares 2 standard transection techniques with the alternative LigaSure technique. METHODS: Forty-eight pigs underwent a DP. Sixteen animals were operated on with a scalpel followed by hand suturing. Sixteen pigs received a DP using an Endo GIA, and the pancreas of 16 pigs was transected with LigaSure. The transection surface of remnant pancreas was observed for liquid collection and abscess on postoperative day 7. RESULTS: Operating time on the day of DP was significantly different, with a shorter operating time in the stapler and LigaSure groups. The morbidity on postoperative day 7 was similar in all groups. CONCLUSION: In the present experimental animal study, LigaSure seems to be fast and safe as well as comparable with the standard transection and closure techniques in DP.

LigaSure versus conventional dissection technique in pancreatoduodenectomy: a pilot study.

BACKGROUND: Pancreatic surgery requires extensive preparation and tissue dissection. Therefore, LigaSure (Valleylab, Boulder, CO) provides an alternative to conventional dissection techniques. The aim of the present study was to describe the feasibility, safety, and cost efficiency of LigaSure in pancreatoduodenectomy. METHODS: Seven patients underwent surgery with the Ligasure and 7 patients underwent surgery with conventional dissection techniques. The patients were investigated for surgical time, intraoperative blood loss, complications, mortality, duration of hospital stay, and surgery-related costs. RESULTS: Surgical time was 207 minutes in the LigaSure group and 255 minutes in the conventional group (P = .020). Intraoperative blood loss was 271 and 771 mL, respectively (P = .010). Other perioperative outcomes were comparable. The respective surgery-related costs averaged €4,125 and €4,931 (P = .023). CONCLUSIONS: The use of LigaSure in pancreatoduodenectomy seems to be feasible and safe. In addition, it might lead to a reduction in the surgery-related costs.

Three-dimensional visualisation improves understanding of surgical liver anatomy.

OBJECTIVES: Three-dimensional (3-D) representation is thought to improve understanding of complex spatial interactions and is being used more frequently in diagnostic and therapeutic procedures. It has been suggested that males benefit more than females from 3-D presentations. There have been few randomised trials to confirm these issues. We carried out a randomised trial, based on the identification of complex surgical liver anatomy, to evaluate whether 3-D presentation has a beneficial impact and if gender differences were evident. METHODS: A computer-based teaching module (TM) was developed to test whether two-dimensional (2-D) computed tomography (CT) images or 3-D presentations result in better understanding of liver anatomy. Following a PowerPoint lecture, students were randomly selected to participate in computer-based testing which used either 2-D images presented as consecutive transversal slices, or one of two 3-D variations. In one of these the vessel tree of portal and hepatic veins was shown in one colour (3-D) and in the other the two vessel systems were coloured differently (3-Dc). Participants were asked to answer 11 medical questions concerning surgical anatomy and four questions on their subjective assessment of the TM. RESULTS: Of the 160 Year 4 and 5 medical students (56.8% female) who participated in this prospective randomised trial, students exposed to 3-D presentation performed significantly better than those exposed to 2-D images (p < 0.001). Comparison of the number of correct answers revealed no significant differences between the 3-D and 3-Dc modalities p > 0.1). Male students gave significantly more correct answers in the 3-D and 3-Dc modalities than female students (p < 0.03). The gender difference observed in both 3-D modalities was not evident in the 2-D group (p = 0.21). CONCLUSIONS: This study showed that 3-D imaging significantly improved the identification of complex surgical liver anatomy. Male students benefited significantly more than female students from 3-D presentations. Use of colour in 3-D presentation did not improve student performance.