Evidence mapping on how to perform an optimal surgical repair of large hiatal hernias.

BACKGROUND: Symptomatic and large hiatal hernia (HH) is a common disorder requiring surgical management. However, there is a lack of systematic, evidence-based recommendations summarizing recent reviews on surgical treatment of symptomatic HH. Therefore, this systematic review aimed to create evidence mapping on the key technical issues of HH repair based on the highest available evidence. METHODS: A systematic review identified studies on eight key issues of large symptomatic HH repair. The literature was screened for the highest level of evidence (LE from level 1 to 5) according to the Oxford Center for evidence-based medicine's scale. For each topic, only studies of the highest available level of evidence were considered. RESULTS: Out of the 28.783 studies matching the keyword algorithm, 47 were considered. The following recommendations could be deduced: minimally invasive surgery is the recommended approach (LE 1a); a complete hernia sac dissection should be considered (LE 3b); extensive division of short gastric vessels cannot be recommended; however, limited dissection of the most upper vessels may be helpful for a floppy fundoplication (LE 1a); vagus nerve should be preserved (LE 3b); a dorso-ventral cruroplasty is recommended (LE 1b); routine fundoplication should be considered to prevent postoperative gastroesophageal reflux (LE 2b); posterior partial fundoplication should be favored over other forms of fundoplication (LE 1a); mesh augmentation is indicated in large HH with paraesophageal involvement (LE 1a). CONCLUSION: The current evidence mapping is a reasonable instrument based on the best evidence available to guide surgeons in determining optimal symptomatic and large HH repair.

Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout.

BACKGROUND: Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy. Coloshield has been developed as a temporary colon occlusion device to facilitate rectal washout. However, effectiveness and safety has not been evaluated in humans. METHODS: Twenty-two patients have been randomly assigned to undergo proctological intervention with a rectal washout with and without the use of Coloshield. Patients and assessors were blinded. Boston Bowel Preparation Scale (BBPS) has been determined 30 min as well as immediately after rectal washout. Feasibility, pain, intra- and postoperative morbidity as well as bowel function and continence 6 weeks after surgery were assessed. RESULTS: BBPS 30 min after rectal washout with and without Coloshield was in mean 2.42 ± 1.02 and 2.12 ± 0.89 (p = 0.042). Mean BBPS immediately after rectal washout was 2.39 ± 1.02 and 2.24 ± 0.66 (p = 0.269). Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711). Coloshield application was feasible without any complications. The median (interquartile range) numeric rating scale for pain 4 h after surgery was 1 (0-1) and 3 (0-4) (p = 0.212). Six weeks after surgery 0/11 and 1/11 patients suffered from evacuation difficulties (p = 1.0) and the median Vaizey-Wexner score was 1 (0-3) and 1 (0-2) (p = 0.360). CONCLUSIONS: Coloshield application in humans is feasible and safe. Slight benefits in rectal preparation by washout are found when Coloshield is used. Colon occlusion by Coloshield for transrectal NOTES should be evaluated within clinical studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT02579330.

Heller myotomy versus endoscopic balloon dilatation for achalasia: A single center experience.

This study aimed to compare clinical results, symptom relief, quality of life and patient satisfaction after the 2 most common procedures for achalasia treatment: laparoscopic Heller myotomy (LHM) and endoscopic balloon dilatation (EBD).Patients treated at University Hospital of Heidelberg with LHM or EBD were included. A retrospective chart review of perioperative data and a prospective follow-up of therapeutic efficiency, Gastrointestinal Quality of Life Index (GIQLI) and patient satisfaction was conducted.Follow-up data (mean follow-up: 75.1 ±â€Š53.9 months for LHM group and 78.9 ±â€Š45.6 months for EBD) were obtained from 36 patients (19 LHM; 17 EBD). Eckardt score (median (q1,q3): 2 (1,4) in both groups, P = .91, GIQLI (LHM: 117 (91.5, 126) vs EBD: 120 (116, 128), P = .495) and patient satisfaction (3 (2,3) vs 3 (2,4), P = .883) did not differ between groups. Fifteen patients (78.9%) in LHM group and 11 (64.7%) in EBD group (P = .562) stated they would undergo the intervention again. All patients with EBD had at least 2 dilatations (100%), whilst only 2 patients (10.5%) had dilatation after LHM (P < .001). There were no complications after EBD, but 2 after LHM (10.5%, P = .517).Both LHM and EBD are able to control symptoms and provide similar quality of life and patient satisfaction. However, reintervention rate was higher following EBD, hence LHM provided a more sustained treatment than EBD.

Contamination After Disinfectant Rectal Washout in Left Colectomy as a Model for Transrectal NOTES: A Randomized Controlled Trial.

BACKGROUND: In natural orifice transluminal endoscopic surgery (NOTES) with transrectal (TR) access the intraoperative opening of the rectal wall poses a risk of intraperitoneal contamination and subsequent infectious complications. A rectal washout with a disinfectant may reduce this risk. The aim of the study was to assess the intraoperative contamination on the circular stapler pin when a rectal washout with povidone-iodine (RW-PI) or Ringer solution was performed in patients undergoing left-sided colectomy. Furthermore, the additional effect of an irrigation instrument on the contamination was evaluated. METHODS: In a patient and assessor blinded randomized controlled trial, patients undergoing left-sided colectomy were assigned to rectal washout with PI with an irrigation instrument (RW-PI; n = 23), rectal washout with Ringer solution with an irrigation instrument (RW-R; n = 21) or rectal washout with Ringer solution without an irrigation instrument (RW; n = 25). An end-to-end anastomosis with a circular stapler was performed. The contamination on the pin of the circular stapler was chosen as primary endpoint in order to simulate the intraabdominal contamination risk during TR NOTES. Secondary endpoints were contamination of the rectal mucosa, peritoneal contamination and postoperative morbidity. RESULTS: The contamination rate of the pin of the circular stapler did not differ (RW-PI 39.1%, RW-R 33.3%, RW 52.0%; P = 0.421), but contamination of the rectal mucosa was reduced (47.8% versus 95.2% versus 100%; P < 0.001) and peritoneal contamination tended to be reduced (39.1% versus 71.4% versus 60.0%; P = 0.09) when a rectal washout with PI was performed. The rates of infectious complications (17.4% versus 9.5% versus 12.0%; P = 0.821) and of overall complications (30.4% versus 28.6% versus 44.0%; P = 0.476) did not differ. CONCLUSIONS: Despite an intense rectal washout with PI, contamination of the stapler pin did not differ. Intraabdominal bacterial translocation was frequently encountered even after disinfectant rectal washout with PI. Further studies might focus on the clinical impact of intraabdominal contamination in TR NOTES.

An ad hoc three dimensionally printed tool facilitates intraesophageal suturing in experimental surgery.

BACKGROUND: Three-dimensional printing (3DP) has become popular for development of anatomic models, preoperative planning, and production of tailored implants. A novel laparoscopic, transgastric procedure for distal esophageal mucosectomy was developed. During this procedure, a space holder had to be introduced into the distal esophagus for exposure during suturing. The production process and evaluation of a 3DP space holder are described herein. MATERIALS AND METHODS: Computer-aided design software was used to develop models printed from polylactic acid. The prototype was adapted after testing in a cadaveric model. Subsequently, the device was evaluated in a nonsurvival porcine model. A mucosal purse-string suture was placed as orally as possible in the esophagus, in the intervention group with and in the control group without use of the tool (n = 8 each). The distance of the stitches from the Z-line was measured. The variability of stitches indicated the suture quality. RESULTS: The median maximum distance from the Z-line to purse-string suture was larger in the intervention group (5.0 [3.3-6.4] versus 2.4 [2.0-4.1] cm; P = 0.013). The time taken to place the sutures was shorter in the control group (P < 0.001). Stitch variance tended to be greater in the intervention group (2.3 [0.9-2.5] versus 0.7 [0.2-0.4] cm; P = 0.051). The time required for design and production of a tailored tool was less than 24 h. CONCLUSIONS: 3DP in experimental surgery enables rapid production, permits repeated adaptation until a tailored tool is obtained, and ensures independence from industrial partners. With the aid of the space holder more orally located esophageal lesions came within reach.

Inflammatory response and peritoneal contamination after transrectal natural orifice specimen extraction (NOSE) versus mini-laparotomy: a porcine in vivo study.

BACKGROUND: Transrectal natural orifice specimen extraction (NOSE) avoids abdominal organ retrieval during laparoscopic procedures and may reduce surgical trauma. However, this has not been proven clinically and transrectal peritoneal contamination is feared to cause infectious complications. This experimental study was designed to evaluate inflammatory response and peritoneal contamination after transrectal NOSE versus mini-laparotomy. METHODS: 24 German Landrace pigs underwent transrectal NOSE (N = 12) or mini-laparotomy (N = 12) for standardized extraction of water-instilled balloon. Blood samples were taken for analysis of leucocytes, CRP, IL-6, IL-10, and TNFα at 6, 12, 24, 48, 72 h as well as 7 and 14 days postoperatively. After 14 days laparoscopy was performed to inspect the abdomen and for microbiological swab sampling. RESULTS: Leucocytes were higher in the NOSE group at 72 h (19.3 ± 3.9/nl vs. 15.8 ± 4.2/nl, p = 0.046). IL-6 was lower in the NOSE group at day 7 (165 ± 100/nl vs. 306 ± 70/nl, p = 0.030). No difference was found comparing inflammatory parameters at all other time points. No difference was found regarding peritoneal contamination, which was 58.3% (7/12) in the NOSE group and 41.7% (5/12) in the MiniLap group (p = 0.414). CONCLUSIONS: The results suggest a pronounced acute inflammatory response after transrectal NOSE compared to mini-laparotomy, while late cytokine response seems to be less after transrectal NOSE, which may reflect less intense wound healing process. Using standardized rectal decontamination and endolumenal colon occlusion transrectal NOSE seems to be safe and comparable to mini-laparotomy with regard to peritoneal contamination. Clinical evidence is needed now to weight transrectal NOSE against mini-laparotomy during laparoscopic surgery.

Transrectal rigid-hybrid NOTES cholecystectomy can be performed without peritoneal contamination: a controlled porcine survival study.

BACKGROUND AND STUDY AIMS: The risk of infectious complications due to peritoneal contamination is a major concern and inhibits the widespread use of transrectal NOTES. A standardized rectal washout with a reversible colon occlusion device in situ has previously shown potential in reducing peritoneal contamination. The aim of this study was to compare the peritoneal contamination rate and inflammatory reaction for transrectal cholecystectomy after ideal rectal preparation (trCCE) and standard laparoscopic cholecystectomy (lapCCE) in a porcine survival experiment. METHODS: Twenty pigs were randomized to trCCE (n = 10) or lapCCE (n = 10). Before trCCE, rectal washout was performed with saline solution. A colon occlusion device was then inserted and a second washout with povidone-iodine was performed. The perioperative course and the inflammatory reaction (leukocytes, C-reactive protein) were compared. At necropsy, 14 days after surgery the abdominal cavity was screened for infectious complications and peritoneal swabs were obtained for comparison of peritoneal contamination. RESULTS: Peritoneal contamination was lower after trCCE than after lapCCE (0/10 vs. 6/10; p = 0.003). No infectious complications were found at necropsy in either group and postoperative complications did not differ (p = 1.0). Immediately after the procedure, leukocytes were higher after lapCCE (17.0 ± 2.7 vs. 14.6 ± 2.3; p = 0.047). Leukocytes and C-reactive protein showed no difference in the further postoperative course. Intraoperative complications and total operation time (trCCE 114 ± 32 vs. 111 ± 27 min; p = 0.921) did not differ, but wound closure took longer for trCCE (31.5 ± 19 vs. 13 ± 5 min; p = 0.002). CONCLUSIONS: After standardized rectal washout with a colon occlusion device in situ, trCCE was associated without peritoneal contamination and without access-related infectious complications. Based on the findings of this study, a randomized controlled clinical study comparing clinical outcomes of trCCE with lapCCE should be conducted.

Balloon Dilatation of the Minor Duodenal Papilla Up to 4 mm is Safe in a Porcine Model.

OBJECTIVES: Balloon dilatation of the minor duodenal papilla is a treatment option for symptomatic pancreas divisum. The histologic effects of balloon dilatation have not yet been evaluated. The aim of this study is to investigate the tolerated extent of dilatation of the minor papilla. MATERIALS AND METHODS: A dilatation of the minor papilla was performed in freshly explanted pancreas of pigs using biliary balloon dilatators. Three organs were not dilated (control group), in each 8 organs a dilatation of 4, 6, and 8 mm, respectively, was performed. Tissue damage was assessed by microscopic evaluation. Ductal wall disruption and perforation as well as a semiquantitative inflammation score was described and compared. RESULTS: Ductal wall disruption was increased by dilatation of 6 (5/8; P=0.019) and 8 mm (6/8; P=0.006) compared with 4 mm (1/8). Median inflammation score was 0 (0 to 0), 1 (0 to 2), and 1 (0 to 2) for dilatation of 4, 6, and 8 mm, respectively (4 vs. 6 mm, P=0.007; 4 vs. 8 mm, P=0.026). No perforation occurred in the 4 (0/8) and 6 mm (0/8) group, 1 perforation occurred in the 8 mm group (1/8). CONCLUSIONS: A dilatation of up to 4 mm seems to be safe. However, dilatation of the minor papilla from 4 mm onwards is increasingly associated with tissue damage. These findings should be considered in endoscopic procedures dilating the minor duodenal papilla.

Transduodenal-transpapillary endopancreatic surgery with a rigid resectoscope: experiments on ex vivo, in vivo animal models and human cadavers.

BACKGROUND: Surgery for chronic pancreatitis is afflicted with high morbidity. A novel transduodenal-transpapillary endopancreatic resection (EPR) may provide a less invasive alternative approach. MATERIALS AND METHODS: After laparoscopic duodenotomy the papilla was dilated and accessed with a rigid resectoscope. A resection of pancreatic head tissue was performed from inside the organ. First, the feasibility and resection volume were assessed in bovine pancreas. Bleeding and intraoperative complications were evaluated in an acute in vivo pig model. Finally, the total laparoscopic approach was tested in human cadavers. RESULTS: EPR was feasible in 6/6 bovine and 5/6 porcine pancreases; in one case the papilla could not be located. The resected surface accounted for 30 (23-39)% of the total pancreatic surface and the resection volume was 14.2 (9-25) cm3. In vivo blood loss was minimal [10 (5-20) ml]. The operating time for EPR was 84 (75-110) min in all cadavers. CONCLUSION: The EPR technique is feasible and provides a resection comparable with duodenum-preserving pancreatic head resection (DPPHR). Given the reduced surgical trauma, EPR may emerge as a minimally invasive alternative to DPPHR.

Laparoscopic transgastric circumferential stapler-assisted vs. endoscopic esophageal mucosectomy in a porcine model.

Background and study aims Extensive endoscopic mucosal resection (EMR) for Barrett's esophagus (BE) may lead to stenosis. Laparoscopic, transgastric, stapler-assisted mucosectomy (SAM) with the retrieval of a circumferential specimen is proposed. Methods SAM was evaluated in two phases. The feasibility of SAM and the quality of specimens were assessed in eight animals. The mucosal healing was evaluated in a 6-week survival experiment comparing SAM (n = 6) with EMR (n = 6). The ratio of the esophageal lumen width (REL) at the resection level measured on fluoroscopy at 6 weeks divided by the width immediately after resection was compared. Results In all animals, a circular mucosectomy specimen was successfully obtained, with a median area of 492 mm2 (interquartile range [IQR] 426 - 573 mm2) and 941 mm2 (IQR 813 - 1209 mm2) using a 21 mm and 25 mm stapler, respectively. In the survival experiments, symptomatic stenosis developed in two animals after EMR and in none after SAM. The REL was 0.27 (0.18 - 0.39) and 0.96 (0.9 - 1.04; P < 0.0001) for EMR and SAM, respectively. Conclusions SAM provides a novel technique for en bloc mucosectomy in BE. In contrast to EMR, mucosal healing after SAM was not associated with stenosis up to 6 weeks after intervention.

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.].

New device for transrectal trocar placement and rectal sealing for NOTES: a porcine in vivo and human cadaver study.

BACKGROUND: To date, hybrid NOTES, combining transvaginal and laparoscopic access, represents the most popular clinically applied NOTES approach enabling surgical handling comparable to laparoscopic surgery. The transrectal route could be used in a similar way; however, suitable devices facilitating feasible transrectal access and rectal sealing are lacking. METHODS: In collaboration with Karl Storz GmbH, we tailored a rectoscope and trocars to facilitate transrectal trocar placement and rectal sealing for hybrid NOTES procedures using rigid instruments. Five German Landrace pigs underwent transrectal hybrid NOTES cholecystectomy using the new devices. In a second experiment, the transferability to human anatomy was assessed in a human cadaver. RESULTS: Using the new devices, transrectal trocar placement and rectal sealing proved to be feasible in both experiments. Transrectal hybrid NOTES cholecystectomy could be performed without complications. CONCLUSION: The presented devices provide a tailored operating platform allowing precise transrectal trocar insertion and feasible sealing of the rectotomy. Consequently, these new instruments may pave the way for transrectal hybrid NOTES procedures and could succeed to clinical use in future.

Direct Observation versus Endoscopic Video Recording-Based Rating with the Objective Structured Assessment of Technical Skills for Training of Laparoscopic Cholecystectomy.

PURPOSE: The validated Objective Structured Assessment of Technical Skills (OSATS) score is used for evaluating laparoscopic surgical performance. It consists of two subscores, a Global Rating Scale (GRS) and a Specific Technical Skills (STS) scale. The OSATS has accepted construct validity for direct observation ratings by experts to discriminate between trainees' levels of experience. Expert time is scarce. Endoscopic video recordings would facilitate assessment with the OSATS. We aimed to compare video OSATS with direct OSATS. METHODS: We included 79 participants with different levels of experience [58 medical students, 15 junior residents (novices), and 6 experts]. Performance of a cadaveric porcine laparoscopic cholecystectomy (LC) was evaluated with OSATS by blinded expert raters by direct observation and then as an endoscopic video recording. Operative time was recorded. RESULTS: Direct OSATS rating and video OSATS rating correlated significantly (x03C1; = 0.33, p = 0.005). Significant construct validity was found for direct OSATS in distinguishing between students or novices and experts. Students and novices were not different in direct OSATS or video OSATS. Mean operative times varied for students (73.4 ± 9.0 min), novices (65.2 ± 22.3 min), and experts (46.8 ± 19.9 min). Internal consistency was high between the GRS and STS subscores for both direct and video OSATS with Cronbach's α of 0.76 and 0.86, respectively. Video OSATS and operative time in combination was a better predictor of direct OSATS than each single parameter. CONCLUSION: Direct OSATS rating was better than endoscopic video rating for differentiating between students or novices and experts for LC and should remain the standard approach for the discrimination of experience levels. However, in the absence of experts for direct rating, video OSATS supplemented with operative time should be used instead of single parameters for predicting direct OSATS scores.

Endolumenal colon occlusion reduces peritoneal contamination during a transrectal NOTES procedure: a controlled porcine survival study.

BACKGROUND: To enable an efficient and enduring decontamination of the rectal mucosa during transanal endosocopic procedures, we developed a device for reversible endolumenal colon occlusion (ColoShield). The aim of this study was to assess the value of ColoShield in reducing peritoneal contamination during a transrectal procedure. METHODS: Sixteen pigs underwent transrectal hybrid NOTES cholecystectomy after standardized disinfective rectal washout either with endolumenal colon occlusion using ColoShield (N = 8) or without colon occlusion (N = 8). Rectal swab samples were taken before and after rectal washout and at the end of the procedure. Peritoneal biopsies for microbiological evaluation were obtained at the end of the procedure and at necropsy 7 days after surgery. RESULTS: Peritoneal contamination at the end of surgery was significantly lower using ColoShield compared to not using colon occlusion [13 (1/8) vs. 75 % (6/8); P = 0.012]. No significant differences were found regarding contamination of rectal swabs and peritoneal contamination at necropsy. CONCLUSION: The application of ColoShield may increase the safety of transrectal NOTES and transanal endoscopic procedures by reducing peritoneal contamination and consecutive infectious complications.

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.

Virtual reality training versus blended learning of laparoscopic cholecystectomy: a randomized controlled trial with laparoscopic novices.

This study compared virtual reality (VR) training with low cost-blended learning (BL) in a structured training program.Training of laparoscopic skills outside the operating room is mandatory to reduce operative times and risks.Laparoscopy-naïve medical students were randomized in 2 groups stratified for sex. The BL group (n = 42) used E-learning for laparoscopic cholecystectomy (LC) and practiced basic skills with box trainers. The VR group (n = 42) trained basic skills and LC on the LAP Mentor II (Simbionix, Cleveland, OH). Each group trained 3 × 4 hours followed by a knowledge test concerning LC. Blinded raters assessed the operative performance of cadaveric porcine LC using the Objective Structured Assessment of Technical Skills (OSATS). The LC was discontinued when it was not completed within 80 min. Students evaluated their training modality with questionnaires.The VR group completed the LC significantly faster and more often within 80 min than BL (45% v 21%, P = .02). The BL group scored higher than the VR group in the knowledge test (13.3 ±â€Š1.3 vs 11.0 ±â€Š1.7, P < 0.001). Both groups showed equal operative performance of LC in the OSATS score (49.4 ±â€Š10.5 vs 49.7 ±â€Š12.0, P = 0.90). Students generally liked training and felt well prepared for assisting in laparoscopic surgery. The efficiency of the training was judged higher by the VR group than by the BL group.VR and BL can both be applied for training the basics of LC. Multimodality training programs should be developed that combine the advantages of both approaches.

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.

Total inverse transgastric resection with transoral specimen removal.

BACKGROUND: Laparoscopic local excision is accepted for gastrointestinal stromal tumors (GIST) and benign lesions of the stomach. Yet, tumors at the gastroesophageal junction, on the posterior wall, or in the distal antrum are difficult to approach. Such tumors often must be exposed via gastrotomy or using a rendezvous maneuver. Our method of total intragastric laparoscopic resection using 'pneumogastrum', rigid laparoscope, and conventional laparoscopic instruments is described in an intuitive video. METHODS: Two cases of total inverse transgastric resection involved resection of a submucosal GIST, one at the front wall of the cardia and the other on the posterior wall of the antrum. The third case required excision of a large prepyloric cystic lesion leading to a gastric outlet stenosis. After insertion of three trocars under laparoscopic control, a further trocar was introduced into the stomach and 'pneumogastrum' was established. Two additional 5-mm trocars were intragastrally placed. Intragastric endoscopy with a rigid optic provided an excellent view. The tumor was exposed resected with a linear stapler. The specimen was inserted into an Endo Pouch™ which was sutured to an orally inserted gastric tube. The Endo Pouch™ was gently pulled transorally. After removal of the intragastric trocars, the entrance points were laparoscopically closed. RESULTS: From the first and second cases, we retrieved GIST tumors. In the third case, we retrieved a gastritis cystica profunda. Postoperative course was uneventful. CONCLUSIONS: Gastric GIST should be resected laparoscopically if negative margins are safely achieved regardless of its size. Tumors at the frontwall and exophytic backwall GIST are addressed by laparoscopic wedge resection. Tumors at the gastrojejunal junction, in the prepyloric region, and fundus as well as submucous GIST of the gastric backwall are best approached by intragastric laparoscopic resection. Transoral specimen retrieval is an interesting option in smaller tumors.

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. METHODS: The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. DISCUSSION: The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection. TRIAL REGISTRATION: The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.