Effect of a newly developed pastille on the salivary flow rate in subjects with dry mouth symptoms: a randomized, controlled, monocentric clinical study.

BACKGROUND: Xerostomia is associated with several diseases and is a side effect of certain drugs, resulting from reduced saliva secretion. Often, aged and sometimes younger people suffer from (idiopathic) xerostomia. Chewing gum and sucking pastilles may relieve symptoms of xerostomia by increasing the salivary flow rate due to the mechanical effect of sucking and gustatory stimulation. Swallowing problems and the urge to cough or experiencing a tickling sensation in the throat might be alleviated through a reduction in dry mouth symptoms. We investigated whether a pastille containing four polysaccharides increased the salivary flow rate and relieved the symptoms of dry mouth. METHODS: Participating subjects with xerostomia were randomized into two equally balanced treatment groups. Subjects received the pastille on Day 1 and a control product (Parafilm®) on Day 3, or vice versa. Unstimulated saliva was collected every 2.5 min for 0-10 min. Stimulated saliva was collected after subjects sucked the pastille or the control product. The salivary flow rate was determined gravimetrically, and, in parallel, the feeling of dry mouth was assessed using a visual analog scale. Saliva surface tension was measured in pooled saliva samples (0-5 min of sampling). Additionally, in stimulated saliva from six subjects who sucked the pastille, the presence of the main ingredient-gum arabic-was examined by Raman spectroscopy. RESULTS: Chewing the pastille significantly increased the mean salivary flow rate by 8.03 g/10 min compared to the mean changes after chewing the control product (+ 3.71 g/10 min; p < 0.0001). The mean score of dry mouth was significantly alleviated by the pastille (- 19.9 ± 17.9 mm) compared to the control product (- 3.3 ± 18.1 mm). No difference between the two products was seen regarding the saliva surface tension. Gum arabic was present in the saliva of all investigated subjects for up to 10 min after sucking the pastille. CONCLUSIONS: The pastille was well tolerated and effective in increasing the salivary flow rate and reducing mouth dryness after sucking. These results were in line with the detection of the main ingredient, gum arabic, in saliva for up to 10 min after sucking the pastille. Trial registration German Register Clinical Trials (Deutsches Register Klinische Studien, DRKS) DRKS-ID: DRKS00017393, Registered 29 May 2019, https://www.drks.de/drks_web/navigate.do?navigationId=trial . HTML&TRIAL_ID = DRKS00017393.

Digit ratio as an endophenotype in a schizophrenia population.

BACKGROUND: Schizophrenia is a debilitating mental health condition affecting the lives of many South Africans. The origins of the heterogeneity in the presentation of the illness remain uncertain. AIM: This cross-sectional study performed a retrospective data analysis to determine the usefulness of digit ratio as an endophenotype in a South African schizophrenia population. SETTING: A large genetic study in a South African schizophrenia population recruited patients from services in the Western and Eastern Cape. METHODS: Complete clinical histories were captured for participants, including sets of images of the face and extremities. Software was utilised to measure the lengths of participants' digits from said images and digit ratios (2D:4D) were calculated. Descriptive analyses were performed on the ratios and statistical differences in digit ratio means were calculated between groups characterised by sex, age of onset and the presence vs absence of positive symptoms. Linear modelling was utilised to assess for correlates between 2D:4D and positive and negative symptom severity using scores obtained from the Positive and Negative Syndrome Scale (PANSS) and Scale for the Assessment of Negative Symptoms (SANS). RESULTS: 2D:4D in male participants did not significantly differ from female participants as in healthy populations. 2D:4D did not significantly correlate with the severity of positive or negative symptoms and 2D:4D means between groups did not significantly relate to age of onset. CONCLUSION: 2D:4D appears to be a possible endophenotype in schizophrenia in this population. 2D:4D, however, may not be as readily identifiable as certain minor physical anomalies and neurological soft signs significantly associated with schizophrenia in this population.

MIEO: a micro-invasive endoscopic operation port system for transluminal interventions-an acute and survival porcine study.

BACKGROUND: A reliable and sterile access through the intestinal wall to ease flexible endoscopic transluminal interventions is still appealing but lacks a suitable port system. METHODS: In a granted industry cooperation, we developed the MIEO-Port, a flexible three components overtube system that provides a temporary hermetic sealing of the intestinal wall to allow endoscopic disinfection and manipulation to gain access to the abdominal cavity. The port features an innovative head part which allows for coupling the port to the intestinal wall by vacuum suction and for controlled jetting the isolated intestinal surface with a disinfectant. The device was tested in vivo in 6 pigs for acute and long-term usability. All animal tests were approved by the local ethics committee. RESULTS: In the acute experiment, the port system supported sealed endoscopic mucosa resection and transluminal cholecystectomy. In the survival study on 5 animals, the MIEO-Port proved its reliability after transcolonic peritoneoscopy. In one animal, a port dislocation occurred after extensive retroperitoneal preparation, one animal revealed bacterial contamination at necropsy; however, all animals showed a favourable course over ten days and offered no signs of peritonitis or abscedation during post-mortem examination. DISCUSSION: To the best of our knowledge, the MIEO-Port system is the first device to provide a reliable and sterile flexible access to the peritoneal cavity that can be used throughout the entire gastrointestinal tract regardless of the access route and which combines hermetic sealing with local sterilization. Further studies are warranted.

Meta-analysis of outcomes following resection of the primary tumour in patients presenting with metastatic colorectal cancer.

BACKGROUND: It is not clear whether resection of the primary tumour (when there are metastases) alters survival and/or whether resection is associated with increased morbidity. This systematic review and meta-analysis assessed the prognostic value of primary tumour resection in patients presenting with metastatic colorectal cancer. METHODS: A systematic review of MEDLINE/PubMed was performed on 12 March 2016, with no language or date restrictions, for studies comparing primary tumour resection versus conservative treatment without primary tumour resection for metastatic colorectal cancer. The quality of the studies was assessed using the MINORS and STROBE criteria. Differences in survival, morbidity and mortality between groups were estimated using random-effects meta-analysis. RESULTS: Of 37 412 initially screened articles, 56 retrospective studies with 148 151 patients met the inclusion criteria. Primary tumour resection led to an improvement in overall survival of 7·76 (95 per cent c.i. 5·96 to 9·56) months (risk ratio (RR) for overall survival 0·50, 95 per cent c.i. 0·47 to 0·53), but did not significantly reduce the risk of obstruction (RR 0·50, 95 per cent c.i. 0·16 to 1·53) or bleeding (RR 1·19, 0·48 to 2·97). Neither was the morbidity risk altered (RR 1·14, 0·77 to 1·68). Heterogeneity between the studies was high, with a calculated I2 of more than 50 per cent for most outcomes. CONCLUSION: Primary tumour resection may provide a modest survival advantage in patients presenting with metastatic colorectal cancer.

Models of wound healing: an emphasis on clinical studies.

BACKGROUND: The healing of wounds has always provided challenges for the medical community whether chronic or acute. Understanding the processes which enable wounds to heal is primarily carried out by the use of models, in vitro, animal and human. It is generally accepted that the use of human models offers the best opportunity to understand the factors that influence wound healing as well as to evaluate efficacy of treatments applied to wounds. OBJECTIVES: The objective of this article is to provide an overview of the different methodologies that are currently used to experimentally induce wounds of various depths in human volunteers and examines the information that may be gained from them. METHODS: There is a number of human volunteer healing models available varying in their invasiveness to reflect the different possible depth levels of wounds. RESULTS: Currently available wound healing models include sequential tape stripping, suction blister, abrasion, laser, dermatome, and biopsy techniques. The various techniques can be utilized to induce wounds of variable depth, from removing solely the stratum corneum barrier, the epidermis to even split-thickness or full thickness wounds. CONCLUSION: Depending on the study objective, a number of models exist to study wound healing in humans. These models provide efficient and reliable results to evaluate treatment modalities.

[Long-term HR-Manometry of the Esophagus: first findings in clinical use]. / Langzeit-HR-Manometrie der Speiseröhre: Erste Beobachtungen aus dem klinischen Einsatz.

Diagnosis of oesophageal motility disorders has been well established for many years now, although circadian gastrointestinal motility is still purely understood. So far, high-resolution manometry (HRM) is only available for short-term measurement in clinical practice to evaluate simultaneous pressure conditions throughout the esophagus. Thus, only a very limited period of time can be investigated. There is evidence that disorders in esophageal motility can cause severe discomfort and symptoms even though they only tend to occur spontaneously. When performing short-term-measurements, these often cannot be detected. Therefore, one can assume that long-term analysis of the esophageal function will provide valuable new insights, which will contribute to more effective medicamenteous and operative treatment in esophageal motility disorders. At our gastrointestinal functional diagnostic laboratory, it has been possible to perform high-resolution manometry over the period of 24 hours since June 2014. We used a manometric probe consisting of 36 pressure sensors which are connected to a mobile recording device for ambulatory measurement. This article describes our experiences in clinical use when performing long-term high-resolution manometry and discusses usability and relevance of the results in the context of the underlying esophageal motility disorder.

Gastrointestinal stromal tumor as entry port for S. intermedius causing bacteremia and multiple liver abscesses. Case report and review of literature.

We report a case of a previously healthy 52-year-old man who presented with fever and liver lesions suspicious for metastatic disease, which proved subsequently to be abscesses. Further workup revealed a gastrointestinal stromal tumor (GIST) in the gastric corpus as entry port to Streptococcus intermedius-associated bacteremia and liver abscesses. After antibiotic treatment and surgical resection of the tumor, the patient recovered well. This unusual case indicates that gastrointestinal stromal tumors can remain undetected until they cause a life threatening infection. A review of recent literature pertaining to GIST and liver abscesses follows.

Comparative evaluation of HD 2D/3D laparoscopic monitors and benchmarking to a theoretically ideal 3D pseudodisplay: even well-experienced laparoscopists perform better with 3D.

BACKGROUND: Though theoretically superior to standard 2D visualization, 3D video systems have not yet achieved a breakthrough in laparoscopy. The latest 3D monitors, including autostereoscopic displays and high-definition (HD) resolution, are designed to overcome the existing limitations. METHODS: We performed a randomized study on 48 individuals with different experience levels in laparoscopy. Three different 3D displays (glasses-based 3D monitor, autostereoscopic display, and a mirror-based theoretically ideal 3D display) were compared to a 2D HD display by assessing multiple performance and mental workload parameters and rating the subjects during a laparoscopic suturing task. Electromagnetic tracking provided information on the instruments' pathlength, movement velocity, and economy. The usability, the perception of visual discomfort, and the quality of image transmission of each monitor were subjectively rated. RESULTS: Almost all performance parameters were superior with the conventional glasses-based 3D display compared to the 2D display and the autostereoscopic display, but were often significantly exceeded by the mirror-based 3D display. Subjects performed a task faster and with greater precision when visualization was achieved with the 3D and the mirror-based display. Instrument pathlength was shortened by improved depth perception. Workload parameters (NASA TLX) did not show significant differences. Test persons complained of impaired vision while using the autostereoscopic monitor. The 3D and 2D displays were rated user-friendly and applicable in daily work. Experienced and inexperienced laparoscopists profited equally from using a 3D display, with an improvement in task performance about 20%. CONCLUSION: Novel 3D displays improve laparoscopic interventions as a result of faster performance and higher precision without causing a higher mental workload. Therefore, they have the potential to significantly impact the further development of minimally invasive surgery. However, as shown by the custom-built 3D mirror display, this effect can be improved, thus stimulating further research.

EndoResect study: endoscopic full-thickness resection of gastric subepithelial tumors.

BACKGROUND AND STUDY AIMS: Endoscopic resection of gastric subepithelial tumors (SETs) carries a high risk of perforation. New techniques such as use of the over-the-scope clip (OTSC) may enable secure endoscopic closure of perforations. We aimed to evaluate the feasibility of endoscopic resection of small gastric SETs using a grasp-and-snare technique followed by OTSC closure of the gastric wall if necessary. PATIENTS AND METHODS: In this prospective study 20 consecutive patients who presented with gastric SETs ≤ 3 cm were enrolled. Endoscopic resection was performed using a double-channel endoscope, a tissue anchor and a monofilament snare. If perforation occurred, the aim was to achieve complete closure with a tissue twin grasper and the OTSC. Procedures were performed under laparoscopic control using a 5-mm optic, which was introduced via a single 5-mm trocar through the umbilicus. All patients were followed up for 3 months after the procedure. RESULTS: In 6 /20 patients a pure endoscopic approach was impossible and a switch to laparoscopic wedge resection was necessary (large tumor size in 2 /6 patients; mainly extraluminal growth in 4 /6 patients). Solely endoscopic resection was successfully performed in the remaining 14 patients. Amongst these, laparoscopic control was impossible in two cases. Perforation occurred in 6 /14 patients but gastric closure with the OTSC was performed successfully in all these cases. No complications occurred and follow-up was unremarkable. CONCLUSION: Endoscopic snare resection enables safe treatment of small gastric SETs (diameter ≤ 3 cm) and seems faster and easier to perform than other endoscopic resection techniques, such as endoscopic submucosal dissection (ESD) or submucosal tunneling. Perforations occurring after full-thickness resection can be adequately managed by OTSC closure. Solely endoscopic resection without laparoscopic control seems possible in selected patients with tumors known to have purely intraluminal growth.

NOTES in Europe: summary of the working group reports of the 2012 EURO-NOTES meeting.

The sixth EURO-NOTES workshop (4 - 6 October 2012, Prague, Czech Republic) focused on enabling intensive scientific dialogue and interaction between surgeons, gastroenterologists, and engineers/industry representatives and discussion of the state of the practice and development of natural orifice transluminal endoscopic surgery (NOTES) in Europe. In accordance with previous meetings, five working groups were formed. In 2012, emphasis was put on specific indications for NOTES and interventional endoscopy. Each group was assigned an important indication related to ongoing research in NOTES and interventional endoscopy: cholecystectomy and appendectomy, therapy of colorectal diseases, therapy of adenocarcinoma and neoplasia in the upper gastrointestinal tract, treating obesity, and new therapeutic approaches for achalasia. This review summarizes consensus statements of the working groups.

Short term clinical efficacy of new meridol HALITOSIS tooth & tongue gel in combination with a tongue cleaner to reduce oral malodor.

OBJECTIVE: This study evaluated the short term efficacy of tongue cleaning with meridol HALITOSIS tooth & tongue gel in comparison to mechanical tongue cleaning alone and untreated after five and 60 minutes in patients with an oral cause of bad breath. METHODS: Fifty-four male and female subjects with an intra-oral cause of halitosis (organoleptic ratings > or = 2 and volatile sulphur compounds > or = 50 ppb) participated in this crossover study and were assigned to six different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA) with no treatment (A), mechanical tongue cleaning alone (B), and tongue cleaning with tooth & tongue gel applied to the tongue cleaner (C). Efficacy was assessed by organoleptic ratings and volatile sulphur compound measurements five and 60 minutes after treatment RESULTS: Cleaning the tongue with tooth & tongue gel applied onto the tongue cleaner resulted in significantly reduced organoleptic ratings (p < 0.001 for the five-minute assessment; p = 0.001 for the 60-minute assessment) and volatile sulphur compounds (H2S + CH3SH: p = 0.005 for the five-minute assessment; p = 0.003 for the 60-minute assessment) compared to no treatment at the five- and 60-minute assessment time points, while mechanical tongue cleaning alone was less effective in reducing organoleptic ratings (p = 0.008 for the five-minute assessment; p = 0.144 for the 60-minute assessment) and volatile sulphur compounds (H2S + CH3SH: p = 0.261 for the five-minute assessment; p = 0.365 for the 60-minute assessment). CONCLUSIONS: Single tongue cleaning with meridol HALITOSIS tooth & tongue gel had a positive effect on halitosis five and 60 minutes after treatment. Tongue cleaning with tooth & tongue gel in combination with other oral hygiene procedures is a promising approach to control halitosis.

Usage of a graph database for the selection of sterile items in the OR.

PURPOSE: In this work, we present a subsystem of a robotic circulating nurse, that produces recommendations for the next supplied sterile item based on incomplete requests from the sterile OR staff, the current situation, predefined knowledge and experience from previous surgeries. We describe a structure to store and query the underlying information in terms of entities and their relationships of varying strength. METHODS: For the implementation, the graph database Neo4j is used as a core component together with its querying language Cypher. We outline a specific structure of nodes and relationships, i.e., a graph. Primarily, it allows to represent entities like surgeons, surgery types and items, as well as their complex interconnectivity. In addition, it enables to match given situations and partial requests in the OR with corresponding subgraphs. The subgraphs provide suitable sterile items and allow to prioritize them according to their utilization frequency. RESULTS: The graph database was populated with existing data from 854 surgeries describing the intraoperative use of sterile items. A test scenario is evaluated in which a request for "Prolene" is made during a cholecystectomy. The software identifies a specific "Prolene" suture material as the most probable requested sterile item, because of its utilization frequency from over 95%. Other "Prolene" suture materials were used in less than 15% of the cholecystectomies. CONCLUSION: We have proposed a graph database for the selection of sterile items in the operating room. The example shows how the partial information from different sources can be easily integrated in a query, leading to an unique result. Eventually, we propose possible enhancements to further improve the quality of the recommendations. In the next step, the recommendations of the software will be evaluated in real time during surgeries.

Deconvolution of 1D NMR spectra: A deep learning-based approach.

The analysis of nuclear magnetic resonance (NMR) spectra to detect peaks and characterize their parameters, often referred to as deconvolution, is a crucial step in the quantification, elucidation, and verification of the structure of molecular systems. However, deconvolution of 1D NMR spectra is a challenge for both experts and machines. We propose a robust, expert-level quality deep learning-based deconvolution algorithm for 1D experimental NMR spectra. The algorithm is based on a neural network trained on synthetic spectra. Our customized pre-processing and labeling of the synthetic spectra enable the estimation of critical peak parameters. Furthermore, the neural network model transfers well to the experimental spectra and demonstrates low fitting errors and sparse peak lists in challenging scenarios such as crowded, high dynamic range, shoulder peak regions as well as broad peaks. We demonstrate in challenging spectra that the proposed algorithm is superior to expert results.

Lack of irritative potential of nadifloxacin 1% when combined with other topical anti-acne agents.

BACKGROUND: Diverse options are available for the treatment of acne. Topical therapy is standard, especially in cases of mild to moderate acne, while the current treatments for acne vulgaris are topical keratolytics and topical antibiotics. Tolerability is a critical factor in patient compliance with topical acne therapies. The simultaneous use of more than one topical preparation with different active ingredients may cause increased irritation. However, the multifactorial aetiologies of acne, and the need to prevent development of bacterial resistance, require new acne-treatment combinations. Combining agents that target the different aetiological factors of acne can help increase efficacy and reduce response time. AIM: To compare the dermal irritation produced by an anti-acne cream containing 1% nadifloxacin with that produced by additional treatment with four different topical anti-acne products in a 21-day open application test in 40 healthy volunteers. METHODS: This was a randomized, double-blind (observer-blind), single-centre, phase I clinical study with an intraindividual comparison. The topic anti-acne products (nadifloxacin, adapalene, benzoyl peroxide, azelaic acid and isotretinoin) were applied without occlusion, either alone or in combination with nadifloxacin, to the skin test areas. One test area was left untreated. RESULTS: Most of the mean irritation scores were 0, and all were < 1. CONCLUSIONS: Combined application of nadifloxacin with any of the other four topical anti-acne products did not lead to substantial intolerance reactions compared with the effects after application of the products alone.

[Clinical value of alternative technologies to standard laparoscopic cholecystectomy - single port, reduced port, robotics, NOTES]. / Klinischer Stellenwert alternativer Technologien zur standardmäßigen laparoskopischen Cholezystektomie ­ Single-Port, Reduced-Port, Roboter, NOTES.

Surgical interventions should ideally treat an existing disease curatively and achieve this with a low complication rate and minimal trauma. In this sense, laparoscopic cholecystectomy has become established as the recognized standard for the treatment of cholecystolithiasis. Newer procedures, such as single-port surgery or natural orifice transluminal endoscopic surgery (NOTES) have recently emerged to reduce the already low interventional trauma even further and to provide a better cosmetic outcome. With all new methods the main aim is the reduction of the transabdominal access points. Based on published results and diagnosis-related groups (DRG) data, this article examines whether this goal has been achieved, also with respect to the overall quality of treatment and the complication rates. In this context and in addition to the already mentioned approaches, robotic cholecystectomy and the reduced port approach are also considered.

[Image-based supportive measures for future application in surgery]. / Bildbasierte Unterstützungsmethoden für die zukünftige Anwendung in der Chirurgie.

BACKGROUND: The development of assistive technologies will become of increasing importance in the coming years and not only in surgery. The comprehensive perception of the actual situation is the basis of every autonomous action. Different sensor systems can be used for this purpose, of which video-based systems have a special potential. METHOD: Based on the available literature and on own research projects, central aspects of image-based support systems for surgery are presented. In this context, not only the potential but also the limitations of the methods are explained. RESULTS: An established application is the phase detection of surgical interventions, for which surgical videos are analyzed using neural networks. Through a time-based and transformative analysis the results of the prediction could only recently be significantly improved. Robotic camera guidance systems will also use image data to autonomously navigate laparoscopes in the near future. The reliability of the systems needs to be adapted to the high requirements in surgery by means of additional information. A comparable multimodal approach has already been implemented for navigation and localization during laparoscopic procedures. For this purpose, video data are analyzed using various methods and these data are fused with other sensor modalities. DISCUSSION: Image-based supportive methods are already available for various tasks and will become an important aspect for the surgery of the future; however, in order to be able to be reliably implemented for autonomous functions, they must be embedded in multimodal approaches in the future in order to provide the necessary security.

Surgical reporting for laparoscopic cholecystectomy based on phase annotation by a convolutional neural network (CNN) and the phenomenon of phase flickering: a proof of concept.

PURPOSE: Surgical documentation is an important yet time-consuming necessity in clinical routine. Beside its core function to transmit information about a surgery to other medical professionals, the surgical report has gained even more significance in terms of information extraction for scientific, administrative and judicial application. A possible basis for computer aided reporting is phase detection by convolutional neural networks (CNN). In this article we propose a workflow to generate operative notes based on the output of the TeCNO CNN. METHODS: Video recordings of 15 cholecystectomies were used for inference. The annotation of TeCNO was compared to that of an expert surgeon (HE) and the algorithm based annotation of a scientist (HA). The CNN output then was used to identify aberrance from standard course as basis for the final report. Moreover, we assessed the phenomenon of 'phase flickering' as clusters of incorrectly labeled frames and evaluated its usability. RESULTS: The accordance of the HE and CNN was 79.7% and that of HA and CNN 87.0%. 'Phase flickering' indicated an aberrant course with AUCs of 0.91 and 0.89 in ROC analysis regarding number and extend of concerned frames. Finally, we created operative notes based on a standard text, deviation alerts, and manual completion by the surgeon. CONCLUSION: Computer-aided documentation is a noteworthy use case for phase recognition in standardized surgery. The analysis of phase flickering in a CNN's annotation has the potential of retrieving more information about the course of a particular procedure to complement an automated report.

[The importance of microbiological results for the treatment of complicated appendicitis-a monocentric case-control study]. / Die Bedeutung mikrobiologischer Ergebnisse für die Therapie der komplizierten Appendizitis ­ eine monozentrische Fall-Kontroll-Studie.

BACKGROUND: Patients with complicated appendicitis frequently develop postoperative septic complications. There are no uniform standards for the choice of perioperative antibiotic prophylaxis and the duration of postoperative antibiotic treatment. The purpose of this study was to investigate associations between microbiological samples and postoperative complications. METHODS: Patients with appendectomy and positive intraoperative swabs during 2013-2018 were included in this case-control study. Pathogen classes and their resistance patterns were evaluated in initial and follow-up swabs and compared in each of the groups with and without complications. RESULTS: A total of 870 patients underwent surgery during the period studied. Pathogen detection succeeded in 102 of 210 cases (48.6%) with suspected bacterial peritoneal contamination. Conversion from laparoscopic to open intra-abdominal perforation and the presence of an abscess were independent risk factors for wound infections in the multivariate analysis. The combination of different classes of pathogens resulted in significantly increased overall resistance to ampicillin/sulbactam in both the initial swabs (57%) and the follow-up swabs (73%). Resistant E. coli strains combined with certain anaerobes were also regularly detected in postoperative intra-abdominal abscesses. Piperacillin/tazobactam was effective against 83% of positive swabs in our resistance tests. CONCLUSION: Surgical treatment for complicated appendicitis remains the central therapeutic column. A regular review of the existing resistance patterns in perforated appendicitis can help to adjust and improve antibiotic treatment. Piperacillin/tazobactam should be used cautiously as a reserve antibiotic. A valid alternative is second or third generation cephalosporins in combination with metronidazole.

Randomized controlled trial of ultrasonic dissection versus standard surgical technique in open left hemicolectomy or total gastrectomy.

BACKGROUND: Ultrasonic dissection devices have been designed for use in open surgery but it is not certain how they compare with standard surgical techniques. METHODS: This was a multicentre randomized controlled trial comparing ultrasonic dissection with the traditional surgical technique for haemostasis and dissection during left hemicolectomy and total gastrectomy. The primary endpoint was duration of operation; secondary endpoints were blood loss and other intraoperative parameters, and patient outcomes. Performance of the two techniques was rated by surgeons and assistants on a ten-point Likert scale. RESULTS: The analysis included 100 patients in the ultrasonic and 101 in the conventional dissection group. Patient demographics, and clinical and tumour-related parameters were similar in the two groups. There was no significant difference in duration of operation (mean 170 and 178 min in ultrasonic and conventional groups respectively; P = 0·405). Nor were there significant differences in intraoperative blood loss (median 350 and 400 ml respectively; P = 0·882), other intraoperative parameters, oncological or functional outcome. The ultrasonic dissector device was rated one point higher than conventional techniques by the surgeons. CONCLUSION: Use of the ultrasonic dissector in open total gastrectomy and hemicolectomy had no impact on the overall operating time or other endpoints studied. Surgeons preferred the ultrasonic device for dissection.

Natural-orifice transluminal endoscopic surgery: low-pressure pneumoperitoneum is sufficient and is associated with an improved cardiopulmonary response (PressurePig Study).

BACKGROUND AND AIMS: The aim of this randomized trial in the acute porcine model was to compare the quality of transgastric peritoneoscopy with the use of low-pressure versus standard-pressure pneumoperitoneum and to evaluate the respective associated cardiopulmonary changes. METHODS: For transgastric peritoneoscopy, carbon dioxide was insufflated via the endoscope for a constant intraperitoneal pressure of 6 mmHg or 12 mmHg in 9 pigs each. The quality of transgastric peritoneoscopy was rated on a visual analog scale (0 mm, min.; 100 mm, max.) by the endoscopist, who was blinded to the intraperitoneal pressure. The cardiac index and global end-diastolic volume index (GEDVI, reflecting preload) were measured every 3 minutes by transpulmonary thermodilution. The following were also recorded: heart rate, mean arterial pressure (MAP), systemic vascular resistance index (SVRI, reflecting afterload), peak inspiratory pressure (PIP), pH, PCO (2), and PO (2). RESULTS: The quality of transgastric peritoneoscopy with the use of low-pressure pneumoperitoneum was not inferior to that obtained using standard-pressure pneumoperitoneum (87.0 mm vs. 87.3 mm; P<0.05). In both groups we observed a statistically significant rise in MAP and SVRI. The increase in SVRI was less pronounced during low-pressure peritoneum ( P=0.042), indicating a reduced stress response in comparison to standard-pressure peritoneum. There were no relevant differences between the groups in relation to cardiac index, GEDVI, and heart rate. An intra-abdominal pressure of 6 mmHg also led to better oxygenation ( P=0.031 for difference in PO (2) between the two groups) due to lower peak inspiratory pressure ( P<0.001 for difference). There were only slight differences between the groups with regard to pH and PCO (2). CONCLUSIONS: Pneumoperitoneum of 12-16 mmHg is used for standard laparoscopy. For NOTES, low-pressure pneumoperitoneum is sufficient and is associated with an improved cardiopulmonary response compared to standard-pressure pneumoperitoneum.