Adherence to fast track measures in colorectal surgery-a survey among German and Austrian surgeons.

PURPOSE: The effectiveness of modern perioperative treatment concepts has been demonstrated in several studies and meta-analyses. Despite good evidence, limited implementation of the fast track (FT) concept is still a widespread concern. To assess the status quo in Austrian and German hospitals, a survey on the implementation of FT measures was conducted among members of the German Society of General and Visceralsurgery (DGAV), the German Society of Coloproctology (DGK) and the Austrian Society of Surgery (OEGCH) to analyze where there is potential for improvement. METHODS: Twenty questions on perioperative care of colorectal surgery patients were sent to the members of the DGAV, DGK and OEGCH using the online survey tool SurveyMonkey®. Descriptive data analysis was performed using Microsoft Excel. RESULTS: While some of the FT measures have already been routinely adopted in clinical practice (e.g. minimally invasive surgical approach, early mobilization and diet buildup), for other components there are discrepancies between current recommendations and present implementation (e.g. the use of local nerve blocks to provide opioid-sparing analgesia or the use of abdominal drains). CONCLUSION: The implementation of the FT concept in Austria and Germany is still in need of improvement. Particularly regarding the use of abdominal drains and postoperative analgesia, there is a tendency to stick to traditional structures. To overcome the issues with FT implementation, the development of an evidence-based S3 guideline for perioperative care, followed by the founding of a surgical working group to conduct a structured education and certification process, may lead to significant improvements in perioperative patient care.

Novel technique of flexible endoscopic therapy of Zenker's diverticulum using a pulsed Holmium laser-a retrospective single-center analysis.

BACKGROUND: In recent years, flexible endoscopic therapy of Zenker's diverticulum seems to become the standard approach. The aim of this study was to assess the safety, efficacy and short-term outcome of flexible endoscopic diverticulotomy of Zenker's diverticulum with a pulsed Holmium laser (PHL). PATIENTS AND METHODS: All patients treated with endoscopic laser-diverticulotomy using a PHL between February 2013 and November 2021 at the University Hospital Salzburg were extracted from our prospectively maintained endoscopic database. Demographic data, size of Zenker's diverticulum, procedure duration, complications, short-term outcome and rate of recurrence were evaluated. RESULTS: In the study period, 45 procedures in 36 patients were performed. Mean depth of the Zenker diverticulum was 21 mm (10-60 mm), mean procedure time was 31 min (15-60 min), intraprocedural adverse events occurred in 2 out of 45 patients (5%) which were both managed endoscopically, post-procedural stenosis occurred in 1 patient (2%). In the follow-up examinations (mean follow-up after 6.4 months), 27 out of 36 patients (75%) were symptom-free, 6 patients (17%) reported an improvement of dysphagia. 3 patients (9%) suffered from persistent dysphagia. After initial symptom relief, a recurrent diverticulum occurred in 5 patients. Endoscopic re-intervention with PHL was done in these cases. CONCLUSIONS: Flexible endoscopic treatment of primary and recurrent Zenker's diverticulum using a PHL is a promising, safe and effective treatment with, in our opinion, technical advantages in comparison to the CO2 laser. Further controlled prospective trials are needed.

Short-term outcomes and costs analysis of robotic-assisted versus laparoscopic cholecystectomy-a retrospective single-center analysis.

PURPOSE: Robotic-assisted surgery is an alternative technique for patients undergoing minimal invasive cholecystectomy (CHE). The aim of this study is to compare the outcomes and costs of laparoscopic versus robotic CHE, previously described as the major disadvantage of the robotic system, in a single Austrian tertiary center. METHODS: A retrospective single-center analysis was carried out of all patients who underwent an elective minimally invasive cholecystectomy between January 2010 and August 2020 at our tertiary referral institution. Patients were divided into two groups: robotic-assisted CHE (RC) and laparoscopic CHE (LC) and compared according to demographic data, short-term postoperative outcomes and costs. RESULTS: In the study period, 2088 elective minimal invasive cholecystectomies were performed. Of these, 220 patients met the inclusion criteria and were analyzed. One hundred ten (50%) patients underwent LC, and 110 patients RC. There was no significant difference in the mean operation time between both groups (RC: 60.2 min vs LC: 62.0 min; p = 0.58). Postoperative length of stay was the same in both groups (RC: 2.65 days vs LC: 2.65 days, p = 1). Overall hospital costs were slightly higher in the robotic group with a total of €2088 for RC versus €1726 for LC. CONCLUSIONS: Robotic-assisted cholecystectomy is a safe and feasible alternative to laparoscopic cholecystectomy. Since there are no significant clinical and cost differences between the two procedures, RC is a justified operation for training the whole operation team in handling the system as a first step procedure. Prospective randomized trials are necessary to confirm these conclusions.

The role of hormones in symptoms and pathophysiology of reflux and esophageal motility disorders.

PURPOSE: A few studies suggest that hormones play a role in the motility of the lower esophagus, but data is rare. In this prospective study we evaluated the correlation between hormones (TSH, fT3, fT4, calcitonin, gastrin, and VIP) and gastroesophageal reflux disease (GERD), esophageal motility disorders, and gastrointestinal symptoms. METHODS: 100 consecutive patients with reflux symptoms and dysphagia were hospitalized for diagnostic evaluation. Self-reporting questionnaires were handed out and patients routinely underwent serum analysis (TSH, fT3, fT4, calcitonin, gastrin, and VIP), 24-hour-pH-impendance monitoring, and high-resolution manometry. RESULTS: Motility disorders were found in 38 out of 86 patients. There were no correlations between hormones, the DeMeester Score, and the lower esophageal sphincter pressure. A strong inverse relation between calcitonin and the Integrated Relaxation Pressure of the esophagogastric junction was found (r=-0.492; p<0.001). No correlations were found between hormone levels and the responses given in the questionnaires. Positive correlations, however, were found between VIP and gastrointestinal symptoms, as well as correlations between fT3 and dysphagia. Within the group with minor motility disorders, TSH and fT4 correlated with outcomes of the SCL-questionnaire. fT4 correlated with the typical symptoms, as well as the gastrointestinal symptoms (diarrhea, constipation, flatulence). TSH correlated with the typical symptoms. Moreover, a correlation between VIP and gas-bloat-symptoms was found within group II CONCLUSIONS: No correlation between TSH, fT3, fT4, gastrin, VIP, calcitonin, and GERD in the sense of acid reflux was found, although calcitonin seems to have an effect on the lower esophageal sphincter.

Incidence and risk factors for umbilical incisional hernia after reduced port colorectal surgery (SIL + 1 additional port)-is an umbilical midline approach really a problem?

PURPOSE: Umbilical midline incisions for single incision- or reduced port laparoscopic surgery are still discussed controversially because of a higher rate of incisional hernia compared to conventional laparoscopic techniques. The aim of this study was to evaluate incidence and risk factors for incisional hernia after reduced port colorectal surgery. METHODS: A total 241 patients underwent elective reduced port colorectal surgery between 2014 and 2020. Follow-up was achieved through telephone interview or clinical examination. The study collective was examined using univariate and multivariate analysis. RESULTS: A total of 150 patients with complete follow-up were included into this study. Mean follow-up time was 36 (IQR 24-50) months. The study collective consists of 77 (51.3%) female and 73 (48.7%) male patients with an average BMI of 26 kg/m2 (IQR 23-28) and an average age of 61 (± 14). Indication for surgery was diverticulitis in 55 (36.6%) cases, colorectal cancer in 65 (43.3%) patients, and other benign reasons in 30 (20.0%) cases. An incisional hernia was observed 9 times (6.0%). Obesity (OR 5.8, 95% CI 1.5-23.1, p = 0.02) and pre-existent umbilical hernia (OR 161.0, 95% CI 23.1-1124.5, p < 0.01) were significant risk factors for incisional hernia in the univariate analysis. Furthermore, pre-existent hernia is shown to be a risk factor also in multivariate analysis. CONCLUSION: We could demonstrate that reduced port colorectal surgery using an umbilical single port access is feasible and safe with a low rate of incisional hernia. Obesity and pre-existing umbilical hernia are significant risk factors for incisional hernia.

Are risk factors for anastomotic leakage influencing long-term oncological outcomes after low anterior resection of locally advanced rectal cancer with neoadjuvant therapy? A single-centre cohort study.

PURPOSE: Anastomotic leakage (AL) poses the most serious problem following low anterior resection in patients with rectal cancer independent of surgical approach or technique. The aim of this study was to evaluate risk factors for the occurrence of AL and how they affect the oncological long-term outcome of patients who received neoadjuvant therapy. METHODS: A single centre cohort study of 163 consecutive locally advanced rectal cancer patients (cT3, cT4, N +) that received neoadjuvant therapy followed by resection with primary anastomosis between January 1998 and December 2020 were included in this study. Short- and long-term findings were compared between patients with AL (Leakage +) and without AL (Leakage -). RESULTS: A complete follow-up was obtained from 163 patients; thereby, 33 patients (20%) developed an AL. We observed more patients with comorbidities (38% vs. 61%, p = 0.049) which developed a leakage in the course. Permanent stoma rate (36% vs. 18%, p = 0.03) was higher, and time between primary operation and stoma reversal was longer (219 days [172-309] vs. 93 days [50-182], p < 0.001) in this leakage group as well. Tumour distance lower than 6 cm from the anal verge (OR: 2.81 [95%CI: 1.08-7.29], p = 0.04) and comorbidities (OR: 2.22 [95%CI: 1.01-4.90], p = 0.049) was evaluated to be independent risk factors for developing an AL after rectal cancer surgery. Oncological outcome was not influenced by AL nor by other associated risk factors. CONCLUSION: We could clearly detect the distance of tumour from the anal verge and comorbidities independent risk factors for the occurrence of AL. Oncological findings and long-term outcome were not influenced by these particular risk factors.

Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal®.

BACKGROUND: AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO2 recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO2 insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO2 insufflators in patients undergoing the most frequently performed laparoscopic procedures. METHODS: One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized to either AirSeal® (group A) or standard pressure CO2 insufflator (group S). The primary endpoints were operative time and level of postoperative shoulder tip pain (Visual Analog Scale). Secondary outcomes included Clavien-Dindo grade complications, surgical side effect and length of hospital stay. RESULTS: Patients were randomized to either group A (n = 101) or group S (n = 97) and were analyzed by intention-to-treat. There was no significant difference in mean operative time between the groups (median [IQR]; 71 min [56-94] in group A vs. 69 min [52-93] in group S; p = 0.434). Shoulder tip pain levels were significantly lower in group S (VAS 0 [0-3] in group S vs. 2 [0-4] in group A; p = 0.001). There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay. CONCLUSION: This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder tip pain compared to standard CO2 insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).

Effects of COVID-19 Pandemic on the Treatment of Pancreatic Cancer: A Perspective from Central Europe.

BACKGROUND: This survey aimed to register changes determined by the COVID-19 pandemic on pancreatic surgery in a specific geographic area (Germany, Austria, and Switzerland) to evaluate the impact of the pandemic and obtain interesting cues for the future. METHODS: An online survey was designed using Google Forms focusing on the local impact of the pandemic on pancreatic surgery. The survey was conducted at 2 different time points, during and after the lockdown. RESULTS: Twenty-five respondents (25/56) completed the survey. Many aspects of oncological care have been affected with restrictions and delays: staging, tumor board, treatment selection, postoperative course, adjuvant treatments, outpatient care, and follow-up. Overall, 60% of respondents have prioritized pancreatic cancer patients according to stage, age, and comorbidities, and 40% opted not to operate high-risk patients. However, for 96% of participants, the standards of care were guaranteed. DISCUSSION/CONCLUSIONS: The first wave of the COVID-19 pandemic had an important impact on pancreatic cancer surgery in central Europe. Guidelines for prompt interventions and prevention of the spread of viral infections in the surgical environment are needed to avoid a deterioration of care in cancer patients in the event of a second wave or a new pandemic. High-volume centers for pancreatic surgery should be preferred and their activity maintained. Virtual conferences have proven to be efficient during this pandemic and should be implemented in the near future.

[Reflux Symptoms - No Difference in Severity and Intensity in Patients with and without Functional Verified Gastroesophageal Reflux Disease]. / Refluxsymptomatik ­ kein Unterschied in Ausprägung und Schweregrad bei Patienten mit und ohne funktionell bewiesene gastroösophageale Refluxerkrankung.

BACKGROUND: Patients with gastroesophageal reflux disease (GERD) often suffer greatly from their symptoms. The aim of this study was to determine if there is a difference in quality of life and gastrointestinal symptom complexes between patients with purely functional complaints and patients with objective GERD. MATERIAL AND METHODS: We included all patients with typical reflux symptoms, who had a GERD examination in 2017 at our department. All patients underwent high resolution manometry, 24-h-pH-metry impedance measurement and gastroscopy. Quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) and gastrointestinal symptoms were rated by a symptom checklist (SCL), assessing the severity and intensity of 14 different symptoms. Based on the results of the 24-h-pH-metry impedance measurement, patients were divided into 2 groups: patients with functional reflux symptoms and patients with true GERD. These two groups were compared. RESULTS: Complete data were available in 162 patients, of whom 86 (52.2%) were objectively suffering from reflux (DeMeester score mean: 37.85; SD ± 29.11) and 76 (46.1%) had a normal DeMeester score (Mean: 7.01; SD ± 4.09). No significant difference in quality of life was found between the two groups (mean GIQLI of GERD patients: 94.81, SD ± 22.40, and mean GIQLI of patients with functional reflux symptoms: 95.26, SD ± 20.33, p = 0.988). Furthermore, no significant difference could be found in the evaluated symptoms (mean general SCL score of GERD patients: 46.97; SD ± 29.23; patients with functional reflux symptoms: 48.03; SD ± 29.17, p = 0.827). CONCLUSION: Patients with functional complaints suffer just as much from their symptoms as patients with objectively diagnosed GERD. Differentiation between gastroesophageal reflux disease and functional reflux symptoms is only possible by means of functional diagnostic testing.

[Planning and Design of a Prospective Randomised Multi-Centre Trial on the Repair of Large Hiatal Hernias with Sutures vs. Pledgeted Sutures vs. Absorbable Mesh]. / Vorstellung einer prospektiv randomisierten Multicenterstudie zum Vergleich der Hiatusplastik mit Nähten vs. Nähte mit Pledgets vs. resorbierbares Netz bei großen Hiatushernien.

BACKGROUND: The hernia recurrence rate after surgical treatment of large hiatal hernias is still very high. The optimal technique to reduce the recurrence rate is still under debate. The aim of this work is to clarify whether pledgeted reinforced sutures or a resorbable mesh can reduce the recurrence rate compared to hiatus closure with only sutures. MATERIALS AND METHODS: An Austria-wide, multi-centre, prospective, randomised study was planned. The study protocol was prepared by the main test centre (University Clinic for General, Visceral and Thoracic Surgery, Paracelsus Medical University Salzburg). The study includes patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia. A large hiatal hernia is defined as > 5 cm in manometry or gastroscopy or at least ⅓ of the stomach lying intrathoracically. The primary study endpoint is defined as the hernia recurrence rate, objectively assessed by gastroscopy. After inclusion in the study, patients will be followed up for 6 months, 1 year, 3 years and 5 years after the operation, using standardised questionnaires and gastroscopy. The power calculation showed a requirement of 55 patients per group. Preoperative randomisation and data management are software-based. RESULTS: The study approval by the leading ethics committee is currently pending and the study itself has been registered on ClinicalTrials.gov since October 2020. The Clinical Trials Registration Number is NCT04591860. Five clinics are participating in the study at the moment and all centres are actively enrolling patients. The duration of the study is set until January 2027. CONCLUSION: This study is the world's first prospective randomised study that examines the value of pledgets and resorbable mesh to reduce the recurrence rate after treatment of large hiatal hernias. The results will help to find the optimal technique to close the hiatus of large hiatal hernias.

Perioperative chemotherapy versus neoadjuvant chemoradiation for patients with adenocarcinoma of the distal esophagus in Austria: a retrospective analysis.

BACKGROUND: The aim of this study was to compare the outcome of patients with adenocarcinoma of the distal esophagus (AEG type I) treated with neoadjuvant chemoradiation or perioperative chemotherapy. METHODS: Eligible patients from four Austrian centers were selected to conduct a retrospective analysis. All patients treated between January 2007 and October 2017 with chemotherapy according to EOX-protocol (Epirubicin, Oxaliplatin, Xeloda) or chemoradiation according to CROSS-protocol (carboplatin/paclitaxel + RTX 41.4 Gy), before esophagectomy were included. Primary outcomes disease-free survival (DFS) and overall survival (OS) as well as secondary outcomes downstaging of T- or N-stage and achievement of pathological complete response pCR (ypT0N0M0) were analyzed. Data of 119 patients were included. RESULTS: Complete data was available in 104 patients, 53 patients in the chemoradiation group and 51 patients in the chemotherapy group. The mean number of lymph nodes removed was significantly higher in the EOX group (EOX 29 ± 15.5 vs. CROSS 22 ± 8.8; p < 0.05). Median follow-up in the CROSS group was 17 months (CI 95% 8.8-25.2) and in the EOX group 37 months (CI 95% 26.5-47.5). In the chemotherapy group, the OS rate after half a year, - 1, and 3 years was 92%, 75%, and 51%. After chemoradiation, overall survival after half a year was 85 %, after 1 year 66%, and after 3 years 17%. In the EOX group DFS after ½, - 1, and 3 years was 90%, 73%, and 45%, in the chemoradiation group after half a year 81%, after 1 year 55% and after 3 years 15%. Pathological complete response (pCR) was achieved in 23% of patients after CROSS and in 10% after EOX (p < 0.000). CONCLUSIONS: There seem to be clear advantages for chemoradiation, concerning the major response of the primary tumor, whereas a tendency in favor for chemotherapy is seen in regards to systemic tumor control. Furthermore, the type of neoadjuvant treatment has a significant influence on the number of lymph nodes resected.

Nonmetastatic pancreatic cancer : Improved survival with chemoradiotherapy > 40 Gy after systemic treatment.

PURPOSE: The role of radiotherapy (RT) for nonmetastatic pancreatic cancer is still a matter of debate since randomized control trials have shown inconsistent results. The current retrospective single-institution study includes both resected and unresected patients with nonmetastasized pancreatic cancer. The aim is to analyze overall survival (OS) after irradiation combined with induction chemotherapy. PATIENTS AND METHODS: Of the 73 patients with nonmetastatic pancreatic cancer eligible for the present analysis, 42 (58%) patients had adjuvant chemoradiotherapy (CRT), while 31 (42%) received CRT as primary treatment. In all, 65 (89%) had chemotherapy at any time before, during, or after RT, and 39 (53%) received concomitant CRT. The median total dose was 50 Gy (range 12-77 Gy), while 61 (84%) patients received >40 Gy. RESULTS: With a median follow-up of 22 months (range 1.2-179.8 months), 14 (19%) are still alive and 59 (81%) of the patients have died, whereby 51 (70%) were cancer-related deaths. Median OS and the 2­year survival rate were 22.9 months (1.2-179.8 months) and 44%, respectively. In addition, 61 (84%) patients treated with >40 Gy had a survival advantage (median OS 23.7 vs. 17.3 months, p = 0.026), as had patients with 4 months minimum of systemic treatment (median OS 27.5 vs. 14.3 months, p = 0.0004). CONCLUSION: CRT with total doses >40 Gy after induction chemotherapy leads to improved OS in patients with nonmetastatic pancreatic cancer.

The potential predictive value of tumor budding for neoadjuvant chemoradiotherapy response in locally advanced rectal cancer.

PURPOSE: This study was conducted to investigate the potential predictive value of tumor budding for neoadjuvant chemoradiotherapy response in locally advanced rectal cancer. PATIENTS AND METHODS: Surgical specimens of 128 ypUICC (Union for International Cancer Control) stage 0-III mid-to-low rectal cancer patients were identified from a prospectively maintained colorectal cancer database and classified into two groups using the 10 high-power field average method: none/mild tumor budding (BD-0) and moderate/severe tumor budding (BD-1). Overall survival, relapse-free survival (RFS), and recurrence estimates were calculated using the Kaplan-Meier method and compared with the log-rank test. For RFS, a multivariable Cox's proportional hazards regression analysis was performed. RESULTS: No (n = 20) or mild (n = 27) tumor budding (BD-0) was identified in 47 (37%) and moderate (n = 52) or severe (n = 29) tumor budding (BD-1) in 81 (63%) surgical specimens. Positive tumor budding (BD-1) was associated with significantly reduced T­level downstaging (P < 0.001) and tumor regression (P < 0.001). After a median follow-up time of 7 years (range 2.9-146.7 months), BD-0 patients had more favorable 5­year RFS (90 vs. 71%, P = 0.02) and distant recurrence (2 vs. 12%, P = 0.03) estimates. Multivariable analyses confirmed BD-1 as a negative predictive parameter for RFS (hazard ratio = 3.44, 95% confidence interval 1.23-9.63, P = 0.018). CONCLUSIONS: Our data confirm tumor budding as a strong prognostic factor and its potential predictive value for neoadjuvant chemoradiotherapy response in locally advanced rectal cancer patients. This provides the opportunity to modify and individualize neoadjuvant therapy regimens for non-responders.

Clinical feasibility of a new full-thickness endoscopic plication device (GERDx™) for patients with GERD: results of a prospective trial.

BACKGROUND: Previous studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL). METHODS: Prospective one-arm trial evaluating the outcome of forty patients with GERD subjected to endoscopic plication with the GERDx™ device. We included patients with at least one typical reflux symptom despite treatment with a PPI for > 6 months, pathologic esophageal acid exposure, hiatal hernia of size < 2 cm, and endoscopic Hill grade II-III. Evaluation of Gastrointestinal Quality of Life Index (GIQLI), symptom scores, esophageal manometry, and impedance-pH-monitoring were performed at baseline and at 3 months after surgery. (Trial Registration: ClinicalTrials.gov NCT 01798212.) RESULTS: There were no intraoperative complications. Four out of forty patients experienced postoperative complications requiring intervention. Seven of forty patients were subjected to laparoscopic fundoplication 3 months after endoscopic plication due to persistent symptoms and were lost to further follow-up. Thirty out of forty patients were available at 3-month follow-up. There was an improvement of the GIQLI score, from a mean of 92.45 ± 18.47 to 112.03 ± 13.11 (p < 0.001). The general reflux-specific score increased from a mean of 49.84 ± 24.83 to 23.93 ± 15.63 (p < 0.001), and the DeMeester score from a mean of 46.48 ± 30.83 to 20.03 ± 23.62 (p < 0.001). There was no significant change in manometric data after intervention. Three of thirty patients continued daily antireflux medication. CONCLUSIONS: Endoscopic plication with the GERDx™ device reduced distal acid exposure of the esophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GERD.

Single-incision surgery trocar-site hernia: an updated systematic review meta-analysis with trial sequential analysis by the Minimally Invasive Surgery Synthesis of Interventions Outcomes Network (MISSION).

BACKGROUND: Single-incision laparoscopic surgery (SILS) is a new technique that aims to minimize abdominal wall trauma and improve cosmesis. Concerns have been raised about the risk of trocar-site hernia following SILS. This study aims to assess the risk of trocar-site hernia following SILS compared to conventional laparoscopic surgery, and investigate whether current evidence is conclusive. METHODS: We performed a systematic search of MEDLINE, AMED, CINAHL, CENTRAL, and OpenGrey. We considered randomized clinical trials comparing the risk of trocar-site hernia with SILS and conventional laparoscopic surgery. Pooled odds ratios with 95% confidence intervals (CI) were calculated using the Mantel-Haenszel method. Trial sequential analysis using the Land and DeMets method was performed to assess the possibility of type I error and compute the information size. RESULTS: Twenty-three articles reporting a total of 2471 patients were included. SILS was associated with higher odds of trocar-site hernia compared to conventional laparoscopic surgery (odds ratio 2.37, 95% CI 1.25-4.50, p = 0.008). There was no evidence of between-study heterogeneity or small-study effects. The information size was calculated at 1687 patients and the Z-curve crossed the O'Brien-Fleming α-spending boundaries at 1137 patients, suggesting that the evidence of higher risk of trocar-site hernia with SILS compared to conventional laparoscopic surgery can be considered conclusive. CONCLUSIONS: Single-incision laparoscopic procedures through the umbilicus are associated with a higher risk of trocar-site hernia compared to conventional laparoscopic surgery.

Applicability of American Joint Committee on Cancer and College of American Pathologists Regression Grading System in Rectal Cancer.

BACKGROUND: Different tumor grading systems have been proposed to predict the association between tumor response and clinical outcome after preoperative chemoradiotherapy in patients with rectal cancer. The American Joint Committee on Cancer and College of American Pathologists regression grading system was recommended as the standard tumor regression grading system for rectal adenocarcinoma. OBJECTIVE: This study evaluated the clinical applicability of the American Joint Committee on Cancer and College of American Pathologists regression grading system in neoadjuvant-treated patients with rectal cancer. DESIGN: This is a retrospective cohort study based on clinical data from a prospectively maintained colorectal cancer database. SETTINGS: This study was performed at a single tertiary referral center. PATIENTS: A total of 144 patients with primary locally advanced mid-to-low rectal adenocarcinoma who underwent preoperative long-course chemoradiotherapy and total mesorectal excision between 2003 and 2012 were included. MAIN OUTCOMES MEASURES: The primary outcome measures were the 5-year overall survival rate, the relapse-free survival rate, the cancer-specific survival rate, and cumulative recurrence rates. RESULTS: Of the 144 patients, 16 (11%) were diagnosed as American Joint Committee on Cancer and College of American Pathologists regression grade 0, 43 patients (30%) as grade 1, 61 patients (42%) as grade 2, and 25 patients (17%) as grade 3.After a median follow-up time of 83 months (range, 3 to 147 mo), 5-year survival estimates for grades 0, 1, 2, and 3, were 93%, 77%, 81%, and 54% for overall survival (p = 0.006); 93%, 82%, 75%, and 55% for relapse-free survival (p = 0.03); and 100%, 86%, 89%, and 63% for cancer-specific survival (p = 0.006). The multivariate Cox regression analyses confirmed the American Joint Committee on Cancer and College of American Pathologists regression grading system as a prognostic factor for overall (p = 0.04), relapse-free (p = 0.02), and cancer-specific survival (p = 0.04). LIMITATIONS: This was a retrospective study. CONCLUSIONS: Our study findings confirm the clinical relevance and applicability of the American Joint Committee on Cancer and College of American Pathologists regression grade system as a predictive factor for patients with rectal cancer. See Video Abstract at http://links.lww.com/DCR/A320.

Temoporfin improves efficacy of photodynamic therapy in advanced biliary tract carcinoma: A multicenter prospective phase II study.

UNLABELLED: Photodynamic therapy using porfimer (P-PDT) improves palliation and survival in nonresectable hilar bile duct cancer. Tumoricidal penetration depth of temoporfin-PDT (T-PDT) is twice that of P-PDT. In a single-arm phase II study we investigated the safety, efficacy, survival time, and adverse events of T-PDT compared with previous data on P-PDT. Twenty-nine patients (median 71 [range 47-88] years) with nonresectable hilar bile duct cancer were treated with T-PDT (median 1 [range 1-4] sessions) plus stenting and followed up every 3 months. The PDT was well tolerated. In patients with occluded segments at baseline (n=28) a reopening of a median of 3 (range 1-7) segments could be achieved: n=16 local response and n=11 stable local disease, one progressive disease. Cholestasis and performance significantly improved when impaired at baseline. Time to local tumor progression was a median of 6.5 (2.7-41.0) months. Overall survival time was a median of 15.4 (range 4.4-62.4) months. Patients died from tumor progression (55%), cholangitis (18%), pneumonia (7%), hemobilia (7%), esophagus variceal hemorrhage (3%), and vascular diseases (10%). Adverse events were cholangitis (n=4), liver abscess (n=2), cholecystitis (n=2), phototoxic skin (n=5), and injection site reactions (n=7). Compared to previous P-PDT, T-PDT shows prolonged time to local tumor progression (median 6.5 versus 4.3 months, P<0.01), fewer PDT treatments needed (median 1 versus 3, P<0.01), a higher 6-month survival rate (83% versus 70%, P<0.01), and a trend for longer overall median survival (15.4 versus 9.3 months, P=0.72) yet not significantly different. The risk of adverse events is not increased except for (avoidable) subcutaneous phototoxicity at the injection site. CONCLUSION: Temoporfin-PDT can safely be delivered to hilar bile duct cancer patients and results in prolonged patency of hilar bile ducts, a trend for longer survival time, and similar palliation as with P-PDT.