[Technique and Study Results of Laparoscopic Gastrectomy for Gastric Cancer]. / Technik und Studienlage der laparoskopischen Gastrektomie bei Magenkarzinom.

The aim of this paper was to describe the technique of laparoscopic gastrectomy for gastric carcinoma and to present a review of current international studies on this topic.The first part describes and documents a standard laparoscopic gastrectomy for carcinoma. In the second part, after an EMBASE and PubMed search, a total of 123 quality-relevant randomised (RCT) and non-randomised (non-RCT) studies on laparoscopic gastrectomy are identified from a primary total of 3,042 hits by systematic narrowing. The study results are then summarised conclusively for the target criteria of feasibility, outcome, oncological quality, morbidity and mortality.Both, laparoscopic subtotal resection for distal gastric carcinomas and laparoscopic gastrectomy can now be performed safely and with few complications. In a recent literature review of a total of 15 RCTs with 5,576 patients (laparoscopic 2,793 vs. open 2,756), there were no significant differences in terms of feasibility, intraoperative outcome and oncological quality (R0 and lymph node harvest). Surgical morbidity and mortality were comparable. Patients after laparoscopic surgery showed a significantly faster early postoperative recovery with a lower overall morbidity. In contrast, the operating time was significantly longer - by a mean of 45 min - compared to the open technique. The advantages of the laparoscopic technique were equally evident in studies on early gastric carcinoma and advanced carcinomas (>T2).Laparoscopic gastrectomy for gastric carcinoma is safe to perform and shows better early postoperative recovery. Complication rates, morbidity and mortality as well as long-term oncological results are comparable with open surgery.

Metachronous carcinoma of the gastric tube following tumour-associated oesophagectomy.

INTRODUCTION: The prognosis of oesophageal carcinoma has improved during the last years. Thereby, the increasing survival has led to increasing occurrence of secondary gastric tube carcinoma (gastric conduit cancer, GTC) following oesophageal tumour resection. MATERIAL AND PATIENTS: A literature review (EMBASE, PubMed), spanning the years 2000 to 2020, identified 342 patients worldwide with a GTC following tumour-related oesophagectomy, of which 306 patients could be included for further analysis. RESULTS: The median age of 306 patients with GTC was 66.4 (39-80) years. 91.2% of patients (n = 279) were male. The median interval between oesophagectomy and GTC was 60.3 (4-236) months. 73.8% of patients (n = 226) were diagnosed as early cancer (EGC, T1) and 26.2% as advanced carcinoma (AGC, > T2; n = 80). Primary oesophagectomy was performed in 97.4% of patients (N = 298) for squamous cell carcinoma. AEG I carcinoma was present in only 5 patients (1.6%). In contrast, 99% (n = 303) of the GTC were found to be adenocarcinomas. One hundred eighty patients (58.8%) could be treated by endoscopic resection (ER). R0 resection was achieved in 82.8% (n = 149). The complication rate was 13.3% (n = 24) and the 30-day mortality 1.1% (n = 2) for ER. Eighty-three patients (27.1%) were treated surgically. These included 13 wedge resections, 25 partial resections and 45 total gastric graft resections with predominantly colon interposition. The R0 rate was 98.8% (n = 82). The postoperative morbidity was 24.1% (n = 20); the 90-day mortality was 6% (n = 5). In 43 patients (14%), palliative chemotherapy or radiotherapy or best supportive care took place. GTC diagnosed early in the EGC stage can be safely managed with ER. In cases of advanced GTC, surgical resection can be a potentially curative approach. Survival times of up to 120 months have been described after intervention for GTC.

[Fluorescence Cholangiography in Comparison to Radiographic Cholangiography During Laparoscopic Cholecystectomy]. / ICG-Fluoreszenzcholangiografie im Vergleich zur konventionellen Röntgencholangiografie im Rahmen einer laparoskopischen Cholezystektomie.

BACKGROUND: The reported incidence rate of bile duct injury (BDI) during laparoscopic cholecystectomy (LC) is 0.3%. However, routine use of intraoperative cholangiography (IOC) is a controversial, due to the additional cost and radiation exposure. The aim of this study was to assess the application of fluorescence cholangiography (FC) in comparison to IOC and to LC without any intraoperative imaging. MATERIALS AND METHODS: This prospective study included 230 patients undergoing LC in our institution. The subjects were divided into two groups. In the first group, with 170 patients, both FC and IOC were performed following a standardised protocol. In second group, with 60 patients, FC was compared to LC without any intraoperative imaging. The data were then analysed with respect to procedure time and identification of predefined anatomical structures. RESULTS: The mean age and body mass index in the first group were 54.4 ± 15.7 years and 27.9 ± 5.7 kg/m², respectively. The mean operative time was 67.6 ± 23.3 min. FC was performed more rapidly than IOC (1.5 ± 0.9 vs.7.3 ± 5.0 min) and visualised the cystic duct (DC) in 67.5% of patients and the common bile duct (DHC) in 66.2% of patients before dissection of Calot's triangle. During dissection, DC and DHC were detected in 95.9% and 71.2% of patients, respectively. BMI > 25 kg/m² and male gender significantly reduced the identification rate of DC before dissection of Calot's triangle. Bile leakage from the liver bed after cholecystectomy was found in 3 cases (1.8%) by FC. In 2 patients (1.2%), IOC visualised the DC joining directly to the right hepatic duct. In 1 of these 2 cases (0.6%), the anatomical variation was identified first by FC. Intraductal filling defects were detected in 9 patients (5.3%) using IOC, compared to 1 patient (0.6%) using FC. In the second group, the visualisation rates of DC and DHC were 80.0 and 53.3%, respectively, with FC and 60.0 and 43.3%, respectively, during LC without any imaging. Surgeons confirmed an increase in safety in 70.0% of patients using FC. CONCLUSION: FC is a simple procedure for non-invasive real-time visualisation of bile duct anatomy during LC. Earlier identification of biliary anomalies and bile leakage increases the operative safety and enables immediate care. In obese patients, FC has limited validity.

Totally Laparoscopic versus Open Gastrectomy for Gastric Cancer: a Matched Pair Analysis.

BACKGROUND: Laparoscopic gastrectomy has been established for treatment of early gastric cancer (EGC) especially in Eastern Asian countries. Currently, it still needs evaluation for advanced gastric cancer (AGC, T ≥ 2). Difficulty is how far Asian study data are valid for western conditions. METHODS: Out of 502 patients who underwent gastric cancer surgery between 2003 and 2016 at Klinikum Suedstadt Rostock 90 patients were selected for a retrospective study to compare totally laparoscopic D2-gastrectomy (LG, n = 45) with open D2-gastrectomy (OG, n = 45). The groups were matched by age, gender and tumour stage (TNM). RESULTS: Average age was 62.9 years (33 - 83), 42.2% were female. There were no differences between both study groups concerning BMI, ECOG and comorbidities. Amounts of EGC and AGC were 35.5% and 64.4% in LG, 28.9% and 71.0% in OG (p = 0.931). In LG-group 53.3% of the patients and in OG-group 51.1% of the patients were nodal negative (p = 0.802). 31.1% of patients in LG and in 33.3% in OG (p = 0.821) undergone perioperative chemotherapy. Total gastrectomy was performed in 73.3% in LG and 82.2% in OG, subtotal resections were done in 26.7% in LG and 17.8% in OG (p = 0.310). Resection free margins (R0) were recognized in 97.8% of the patients in both groups, and for EGC in all cases (p = 0.928). Total numbers of retrieved lymph nodes were significant higher in LG (33.1, 17 - 72) than in OG (28.2, 14 - 57). A significant longer operation time was noticed for laparoscopic gastrectomy in contrast to open surgery (+ 43.0 ± 27.2 min, p = 0.0054). Overall morbidity in OG (44.4%) was twice as high as in LG (22.2%, p < 0.05) due to lower rate of minor complications (Clavien I - II) in LG (LG vs. OG: 13.3% vs. 37.8%, p = 0.0078). For major complications (Clavien ≥ III) no difference between both groups was detected (LG vs. OG: 8.8% vs. 6.6%, p = 0.69). LG showed a significant faster postoperative recovery with earlier oral fluid intake (LG vs. OG: 25.9 h vs. 46.2 h) and shorter time to first flatus (LG vs. OG: 81.6 vs. 102.6 h). Patients after LG were earlier out of bed (LG vs. OG: 69.7 h vs. 108.7 h) and also hospital stay was significantly shorter (11.9 days in LG vs. 16.3 days in OG, p = 0.037). 30- and 90-days mortality was equal for LG and OG (0 and 2.2% per group). After a median follow up of 51.9 month (1 - 117) there were similar results for 3- and 5-year overall survival (OS for LG: 75.6% and 64.6% vs. OG: 68.9% and 64.6%, p = 0.446). Also no differences for 3- and 5-year OS were detected concerning patients without lymph node metastases (LG: 91.7% and 83.4% vs. OG: 91.3% and 78.3%, p = 0.658) or lymph node positive patients (LG: 47.6% and 38.1% vs. OG: 40.9% and 31.8%, p = 0.665). CONCLUSION: Despite western conditions laparoscopic D2 gastrectomy is certainly a save and feasibly approach for surgical therapy of EGC and AGC with low morbidity and mortality, and faster postoperative recovery. The oncologic outcome seems to be equivalent to open surgery.

Update in Natural Orifice Translumenal Endoscopic Surgery (NOTES).

PURPOSE OF REVIEW: The recent developments and clinical applications of natural orifice translumenal endoscopic surgery (NOTES)-procedures and technologies are going to be presented. RECENT FINDINGS: In experimental as well as clinical settings, NOTES-procedures are predominantly performed in hybrid technique. Current experimental studies focus on the implementation of new surgical approaches as well as on the training of procedures. One emphasis in the clinical application is transrectal and transanal interventions. Transanal total mesorectal excision is equivalent to laparoscopic procedures but with the benefit of an even less invasive access. Transvaginal cholecystectomy can achieve results that are comparable to surgeries that are performed with laparoscopic techniques alone. An analysis of the German NOTES-Register concerning appendectomies as well as the national performance of NOTES-interventions in Switzerland is presented. Apart from intraabdominal approaches, several centers proclaim transoral thyroidectomies and transoral mediastinoscopies. SUMMARY: NOTES-procedures are performed in animal experiments as well as in clinical setting although with less frequency. At this time, hybrid techniques using rigid instruments are mainly applied.

Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler.

BACKGROUND: The objective of this study was to evaluate the safety and efficacy of a novel 5-mm laparoscopic linear stapler in clinical gastrointestinal surgical applications. METHODS: A prospective, single-arm study with an open enrollment of subjects requiring stapling of the gastrointestinal (GI) tract was performed. The study endpoints were the number of complications and technical failures associated with the use of a novel stapler when compared to similar events with conventional staplers as described in the medical literature. RESULTS: Seven centers enrolled 160 subjects, 150 of which were followed up to at least 30 days postoperatively. Intraoperative success: In 423 deployments, there were two staple line leaks and five staple line bleeds, all of which were intraoperatively resolved. In addition, incomplete staple lines were noted as a result of user error (n = 15) or device-related issues (n = 22), all of which were immediately resolved and none of which resulted in a complication or a change of the surgical procedure. Late outcomes: A total of 13 surgical complications in 160 patients were related to a GI transection or anastomosis, 12 of which related to a hand-sewn anastomosis or use of other commercially available staplers. One event (1/153, 0.065 %) on POD 1, involving bleeding of the staple line, was felt to be related to the use of the new stapler. CONCLUSION: The study confirmed that the new device was user-friendly (9 % incidence of problems firing the device), reliable (3 % device failures) and safe (<1 % complication rate related to the stapler). Based on these results, it would seem that this new 5-mm stapler is a safe and effective alternative to standard 12-mm staplers.

Clinical NOTES appendectomy study: comparison of transvaginal NOTES appendectomy in hybrid technique with laparoscopic appendectomy.

PURPOSE: The proposed advantages of NOTES are aimed to assess the comparison with standard procedures. Complications are a major focus of its evaluation. We initiated a prospective comparison between transvaginal hybrid appendectomy versus laparoscopic appendectomy. PATIENTS AND METHODS: For each, NOTES and laparoscopic appendectomy, 10 consecutive female patients participated in the study with follow-up documentation for 35 days and after 1 year. Transvaginal appendectomy was considered a non-standard medical procedure and required individual patient's consent. Pre- and postoperative gynecological examinations were performed. Questionnaire-based evaluation included issues related to quality of life in addition to objective clinical findings. The study is approved by the ethics committee of the University of Rostock. RESULTS: All women returned questionnaires for evaluation. Age and BMI are comparable. Overall procedure time was significantly shorter in laparoscopy. The only postoperative complication consisted of an intra-abdominal abscess after laparoscopic appendectomy. One patient of the NOTES group suffered from new abdominal pain 3 weeks postoperatively; a mini-laparoscopy showed a normal situation. Significant differences (p < 0.05) of the questionnaire-based comparison with advantages for the NOTES group were found in following items: reduced activity at day 1-14, postoperative pain at day 1, general health conditions at day 1-3 and quality of life at day 3. NOTES patients wished significantly earlier to be discharged and started significantly earlier with activities, but no differences existed after 4 weeks. CONCLUSIONS: Transvaginal flexible appendectomy appears to be a safe procedure performed in hybrid technique. Data from the study point to shortened recovery intervals and improved quality of life.

Perioperative hemostasis management in patients with von Willebrand disease: an institutional experience.

OBJECTIVES: Patients with von Willebrand disease (vWD) undergoing surgery are routinely treated with von Willebrand factor (vWF)/factor VIII (FVIII) concentrate to control bleeding risk, but consensus is lacking on optimal dosing. This study aimed to evaluate the efficacy and safety of tailored doses of vWF/FVIII concentrate according to intervention-associated bleeding risk in vWD patients undergoing surgery. METHODS: This was a retrospective analysis of vWD patients who underwent surgical procedures at a haemophilia centre. Patients received vWF/FVIII concentrate with dosage and duration of treatment dependent on intervention type (dental, gynaecological, abdominal or orthopaedic/traumatic) and bleeding risk (moderate/high). RESULTS: Eighty-three surgical procedures (42 patients) were included. Median preoperative loading doses of vWF/FVIII concentrate were 29.9 IU/kg and 35.7 IU/kg for interventions with moderate ( n  = 16) or high ( n  = 67) bleeding risk, respectively. The median perioperative dose was highest in orthopaedic or trauma-related surgery (140 IU/kg) and lowest in dental or gynaecological interventions (76.4 IU/kg and 80.0 IU/kg, respectively). During follow-up, no bleeding or other complications were observed in 95% of patients. CONCLUSIONS: Individually tailored doses of vWF/FVIII concentrate according to intervention-associated bleeding risk were effective in preventing postoperative bleeding, with few complications observed. These doses may be used as guidance in routine clinical care.

Improved laparoscopic treatment of symptomatic urachal anomalies.

PURPOSE: Remaining urachal anomalies are seldom found but can result in long-standing recurrent symptoms and repeated surgery. In this single-centre study, we evaluated the laparoscopic approach of excision of the urachus leaving the umbilicus untouched. METHODS: Twenty-one patients were operated on for persisting symptomatic urachal anomalies between 1998 and 2011. Patients included 8 males and 13 females (mean 28.5 years, range 15-72 years). Patients' histories, surgical data and demographic data were prospectively collected and analysed. During follow-up, patients were evaluated using the total body image and cosmesis questionnaire (BIQ). RESULTS: Excision of the urachus was carried out in 18 cases in a laparoscopic three-trocar technique and in 3 cases using single-site surgery. In all cases, the infected umbilicus was left untouched. Mean surgical time of all procedures was 55.7 min (31-106 min). Histopathology confirmed an urachal anomaly in all cases. The former discharging or infected umbilicus healed without any complications. Sixteen patients could be included for the BIQ. Total body image score after surgery was 5.49 with a score of 5.0 being the most satisfactory result possible. The total cosmetic score was 21.37 close to the maximum score of 24. CONCLUSIONS: The laparoscopic treatment of urachal anomalies using a three-trocar technique or the single-site surgery technique is both safe and effective. In our opinion, the excision of the umbilicus should be avoided. It simplifies the procedure and leads to satisfactory cosmetic results.

Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial (DRKS00025765).

INTRODUCTION: The only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG). METHODS AND ANALYSIS: This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy.The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up. ETHICS AND DISSEMINATION: Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access. TRIAL REGISTRATION NUMBER: DRKS00025765.

Use of fluorescence imaging and indocyanine green during laparoscopic cholecystectomy: Results of an international Delphi survey.

BACKGROUND: Published empirical data have increasingly suggested that using near-infrared fluorescence cholangiography during laparoscopic cholecystectomy markedly increases biliary anatomy visualization. The technology is rapidly evolving, and different equipment and doses may be used. We aimed to identify areas of consensus and nonconsensus in the use of incisionless near-infrared fluorescent cholangiography during laparoscopic cholecystectomy. METHODS: A 2-round Delphi survey was conducted among 28 international experts in minimally invasive surgery and near-infrared fluorescent cholangiography in 2020, during which respondents voted on 62 statements on patient preparation and contraindications (n = 12); on indocyanine green administration (n = 14); on potential advantages and uses of near-infrared fluorescent cholangiography (n = 18); comparing near-infrared fluorescent cholangiography with intraoperative x-ray cholangiography (n = 7); and on potential disadvantages of and required training for near-infrared fluorescent cholangiography (n = 11). RESULTS: Expert consensus strongly supports near-infrared fluorescent cholangiography superiority over white light for the visualization of biliary structures and reduction of laparoscopic cholecystectomy risks. It also offers other advantages like enhancing anatomic visualization in obese patients and those with moderate to severe inflammation. Regarding indocyanine green administration, consensus was reached that dosing should be on a milligrams/kilogram basis, rather than as an absolute dose, and that doses >0.05 mg/kg are necessary. Although there is no consensus on the optimum preoperative timing of indocyanine green injections, the majority of participants consider it important to administer indocyanine green at least 45 minutes before the procedure to decrease the light intensity of the liver. CONCLUSION: Near-infrared fluorescent cholangiography experts strongly agree on its effectiveness and safety during laparoscopic cholecystectomy and that it should be used routinely, but further research is necessary to establish optimum timing and doses for indocyanine green.

Problems of randomization to open or laparoscopic sigmoidectomy for diverticular disease.

PURPOSE: Although complicated sigmoid diverticulitis is the most common reason for laparoscopic sigmoidectomy, the level of evidence for preference of the laparoscopic approach is low. METHODS: A multicenter, randomized clinical trial comparing laparoscopic and open sigmoidectomy for diverticulitis was conducted to evaluate the short- and mid-term outcome after both techniques. Data were assessed from randomized patients and from patients who refused randomization. Results of the here presented interim analysis describe the difficulties in randomization leading to abortion of recruitment. RESULTS: 149 patients were enrolled in the randomized trial within 36 months until the interim analysis. A further 294 nonrandomized patients who preferred one of both surgical approaches were assessed. Several differences between these groups were apparent including simple epidemiological characteristics such as age (65 vs. 60 years, p < 0.001), gender (65% vs. 55% female, p = 0.05), BMI (27 vs. 26 kg/m(2), p = 0.01), and ASA class < III (72% vs. 87%, p < 0.001). CONCLUSION: The majority of eligible patients refused a random allocation. A widespread presumption of the advantages of laparoscopic surgery was probably the main reason for refusal. Patients participating in randomization did not reflect the general population in recruiting hospitals. Future trials comparing minimal invasive procedures should be conducted before presumptions concerning the outcome are widespread in the general population.

[Evidence in minimally invasive oncological gastric surgery]. / Evidenz in der minimal-invasiven onkologischen Chirurgie des Magens.

BACKGROUND: The aim of this study was to systematically review the current evidence on laparoscopic and robotic distal and total gastrectomy in comparison to open surgery. MATERIAL AND METHODS: A systematic search of EMBASE and PubMed was conducted and 197 randomized (RCT) and non-randomized (non-RCT) studies were identified. An evaluation of early gastric cancer (EGC) and advanced (AGC) gastric cancer was carried out. RESULTS: For EGC and laparoscopic distal resection (LDG) and total gastrectomy (LTG) a total of 10 RCT and 6 non-RCT, including 4329 patients (laparoscopic 2010 vs. open 2319) were identified. At a high evidence level (1+, 1++) there was no significant difference in terms of feasibility, intraoperative outcome and oncological quality, mortality and long-term oncological outcome compared to open gastrectomy (OG). After LDG and LTG patients showed a significantly faster early postoperative recovery and lower total morbidity. In contrast, the operation times were significant longer compared to ODG and OTG. For distal AGC and LDG in 6 RCT, including 2806 patients (LDG 1410 vs. ODG 1369) comparable results could be found also with a high evidence level (1++). The evidence for LTG in cases of AGC was lower (2-, 2+). Currently ,only 6 non-RCT with a total of 1090 patients (LTG 539 vs. OTG 551) are available, which showed comparable results to LDG but further high-quality RCTs are necessary. Robotic gastrectomy (RG) is currently being evaluated. According to the first studies RG for EGC seems to be equivalent to LDG; however, the evidence is currently low (3 to 2-).

[Appendectomy: open versus laparoscopic versus single port : Evidence for choice of surgical procedure]. / Appendektomie: offen vs. laparoskopisch vs. Single-Port : Evidenz der operativen Verfahrenswahl.

The treatment of choice in acute appendicitis is still the surgical removal of an inflamed vermiform appendix. There is still some disagreement regarding the optimal access route, i.e. conventional open or minimally invasive. The best available evidence is used to answer the question of the current optimal choice of procedure. For laparoscopic appendectomy there are evidence-based benefits in terms of access trauma, postoperative pain, wound infection rates and convalescence. For the alternative minimally invasive procedure single port appendectomy, mini-laparoscopic appendectomy or NOTES appendectomy, there is still a lack of scientific evidence to advocate the broad clinical use of these procedures. It is recommended that whenever the infrastructure permits, laparoscopic appendectomy should be the treatment of choice.

Intensified irinotecan-based neoadjuvant chemoradiotherapy in rectal cancer: four consecutive designed studies to minimize acute toxicity and to optimize efficacy measured by pathologic complete response.

BACKGROUND: The objective of the present study was to analyse toxicity and efficacy of irinotecan-based neoadjuvant chemoradiotherapy by the help of four consecutively planed and prospectively performed phase II studies. PATIENTS AND METHODS: Patients with locally advanced rectal cancer received radiotherapy and concurrently chemotherapy consisting 5-Fu/capecitabine in a continuous or intermittent application and irinotecan in two different total doses (240 vs. 200 mg/m(2)). RESULTS: Diarrhea CTC grade III was seen in 35% in continuous application of 5-Fu/capecitabine versus 12.5% in intermittent application (p= 0,008). Complete response according to the irinotecan dose during chemoradiotherapy (240 mg/m(2) vs. 200 mg/m(2)) was 24% and 0%. CONCLUSIONS: Chemoradiotherapy of the last phase II study with intermittent capecitabine (1500 mg/m(2)/day, delivered on days 1-14 and 22-35) and irinotecan (4 x 60 mg/m(2)) concurrently to radiotherapy is a safe treatment with low toxicity and high efficacy.

Duodenal Electric Stimulation: Results of a First-in-Man Study.

BACKGROUND: The aim of this study was to demonstrate feasibility and safety of a new electric duodenal stimulation system (EDS, BALANCE) in humans. Secondary objectives were to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM). METHODS: In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 obese T2DM patients with a mean HbA1c of 8.0% received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. The follow-up period after implantation was 12 months. RESULTS: Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8% (p = 0.02) and mean fasting blood glucose level (FBG) was reduced by 19% (p = 0.038) after the 12 months. Mean HDL level increased from 44 to 48 mg/dl (p = 0.033). CONCLUSIONS: EDS is a feasible and safe procedure. Positive effects on T2DM and some cardiovascular parameters (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.

Surgical strategies in the laparoscopic therapy of cholecystolithiasis and common duct stones.

BACKGROUND: The purpose of the present study was to examine the current approach and different strategies adopted for laparoscopic cholecystectomy in Germany. METHODS: A retrospective survey was conducted at 859 (n = 1200; 67.6%) hospitals in Germany. Data from 123 090 patients who had undergone cholecystectomy were analysed. RESULTS: 71.9% of the operations were finished laparoscopically (n = 88 537) whereas 22.5% were carried out using the open technique. Conversion to open surgery was required in 7.1% of the laparoscopically started operations. When common bile duct stones were diagnosed preoperatively, 74.4% of the participants favoured the primary endoscopic extraction, following laparoscopic cholecystectomy. In cases of intraoperative diagnoses, laparoscopic cholecystectomy was finished and postoperative primary endoscopic extraction was carried out in more than half of the hospitals (58.4%). Sixteen per cent converted to an open operation with simultaneous exploration of the common duct. Laparoscopic desobstruction of the common bile duct was extremely rare (4.4%). Compared with open cholecystectomy, the results show a lower incidence of postoperative reinterventions (0.9 vs 1.8%) and fatal outcomes (0.04 vs 0.53%) for laparoscopic cholecystectomy. In contrast, common bile duct injuries were more frequent in the laparoscopic cholecystectomy group (0.32 vs 0.12%). The median duration of hospitalization was 6.1 days (range: 2.8-12) in the laparoscopic cholecystectomy group compared with 10.4 days (range: 3-28) in the open cholecystectomy group. CONCLUSIONS: Laparoscopic cholecystectomy is the standard procedure for the treatment of uncomplicated gallstone disease. There are reasonable differences between the hospitals in type of cholecystectomy for acute cholecystitis, management of common duct stones and intraoperative diagnostics in laparoscopic cholecystectomy, even after adjustment for differences in patient comorbidities.

Value and consequences of routine intraoperative cholangiography during cholecystectomy.

Since the introduction of laparoscopic cholecystectomy (LC), an increase in accidental common bile duct (CBD) injuries of up to 1.2-1.6% has been reported. In the present prospective study of 1,710 patients undergoing cholecystectomy (1,241 LC procedures and 469 open cholecystectomies [OC]), we tested the predicative value of routine intraoperative cholangiography (IOC). The IOC was feasible in 92.4% of the cases in the LC group and in 83% of cases in the OC group and presented a complete depiction of the extrahepatic bile system in 98.3%. Anatomic variations of the bile duct system, which influenced the operative management, were found in 13.2% of cases (13.4% LC versus 12.8% OC). In 2.5% of the patients, preoperatively undetected CBD stones were also found. Method-specific complications did not occur in any of the patients. Additionally, in a controlled subgroup analysis of 163 patients, we evaluated preoperative intravenous cholangiography (IVC) and IOC. Intravenous cholangiography showed only 72.4% of the operation-relevant anatomic variations (vs. 100% by IOC); in 6.1% of the cases, there were reactions to the dye (vs. none in IOC), and in only 28.6% of the patients, CBD stones were detected (vs. 71.4% IOC). There were four bile duct injuries (0.29%) during LC and two (0.4%) during OC. All injuries were detected intraoperatively and fixed in the same setting without postoperative complications. In conclusion, we recommend the use of routine IOC during cholecystectomy. By this technique, anatomic variations of the bile duct system will be visualized and therefore accidental injuries will be avoided.

[Nutritional recommendations, supplementation, and physical activity program following Roux-en-Y gastric bypass for morbid obesity]. / Ernährungsumstellung, Supplementation und Bewegungsprogramm nach Roux-Y-Magenbypass.

The number of gastric bypass operations (RYGB) needed worldwide is increasing annually due to the obesity epidemic.Yet the success of this treatment is only guaranteed if an appropriate exercise therapy, a corresponding change of diet, and an adequate supplementation take hold in the aftercare program.Subject to pre-existing musculoskeletal diseases, exercise therapy should start about 4 weeks after the operation and comprise alternating cardiovascular and connective tissue-restitution training. The required change of diet focuses on small portions of calorie-reduced as well as protein- and vitamin enriched food. The standard daily intake should be between 800 and 1,200 kcal. However, after RYGB, nutritive deficiencies have been registered for proteins in 1-3%, for iron in 45-52%,vitamin B12 in 33-37%, folic acid in about 35%, calcium in 10-12%, and vitamins in 10-45% of the patients. For this reason,laboratory analysis at regular intervals is necessary in the follow-up and an appropriate supplementation of minerals, vitamins,and trace elements must be implemented.