SEVTAR-A multicenter randomized controlled trial to investigate the impact of prophylactic endoluminal placed vacuum sponge for prevention of anastomotic leakage after low rectal resections.

Background: Low anterior resection for rectal cancer is commonly associated with a diverting stoma. In general, the stoma is closed 3 months after the initial operation. The diverting stoma reduces the rate of anastomotic leakage as well as the severeness of a potential leakage itself. Nevertheless, anastomotic leakage is still a life-threatening complication and might reduce the quality of life in the short and long term. In case of leakage, the construction can be converted into a Hartmann situation or it could be treated by endoscopic vacuum therapy or by leaving the drains. In recent years, endoscopic vacuum therapy has become the treatment of choice in many institutions. In this study, the hypothesis is to be evaluated, if a prophylactic endoscopic vacuum therapy reduces the rate of anastomotic leakage after rectal resections. Methods: A multicenter parallel group randomized controlled trial is planned in as many as possible centers in Europe. The study aims to recruit 362 analyzable patients with a resection of the rectum combined with a diverting ileostoma. The anastomosis has to be between 2 and 8 cm off the anal verge. Half of these patients receive a sponge for 5 days, and the control group is treated as usual in the participating hospitals. There will be a check for anastomotic leakage after 30 days. Primary end point is the rate of anastomotic leakages. The study will have 60% power to detect a difference of 10%, at a one-sided alpha significance level of 5%, assuming an anastomosis leakage rate of 10%-15%. Discussion: If the hypothesis proves to be true, anastomosis leakage could be reduced significantly by placing a vacuum sponge over the anastomosis for 5 days. Trial registration: The trial is registered at DRKS: DRKS00023436. It has been accredited by Onkocert of the German Society of Cancer: ST-D483. The leading Ethics Committee is the Ethics Committee of Rostock University with the registration ID A 2019-0203.

Temperature profile and residual heat of monopolar laparoscopic and endoscopic dissection instruments.

BACKGROUND: Endoscopic and laparoscopic electrosurgical devices (ED) are of great importance in modern medicine but can cause adverse events such as tissue injuries and burns from residual heat. While laparoscopic tools are well investigated, detailed insights about the temperature profile of endoscopic knives are lacking. Our aim is to investigate the temperature and the residual heat of laparoscopic and endoscopic monopolar instruments to increase the safety in handling ED. METHODS: An infrared camera was used to measure the temperature of laparoscopic and endoscopic instruments during energy application and to determine the cooling time to below 50 °C at a porcine stomach. Different power levels and cutting intervals were studied to investigate their impact on the temperature profile. RESULTS: During activation, the laparoscopic hook exceeded 120 °C regularly for an up to 10 mm shaft length. With regards to endoknives, only the Dual Tip Knife showed a shaft temperature of above 50 °C. The residual heat of the laparoscopic hook remained above 50 °C for at least 15 s after activation. Endoknives cooled to below 50 °C in 4 s. A higher power level and longer cutting duration significantly increased the shaft temperature and prolonged the cooling time (p < 0.001). CONCLUSION: Residual heat and maximum temperature during energy application depend strongly on the chosen effect and cutting duration. To avoid potential injuries, the user should not touch any tissue with the laparoscopic hook for at least 15 s and with the endoknives for at least 4 s after energy application. As the shaft also heats up to over 120 °C, the user should be careful to avoid tissue contact during activation with the shaft. These results should be strongly considered for safety reasons when handling monopolar ED.

A novel ex vivo model for critical illness neuromyopathy using freshly resected human colon smooth muscle.

Patients suffering from critical illness are at risk to develop critical illness neuromyopathy (CINM). The underlying pathophysiology is complex and controversial. A central question is whether soluble serum factors are involved in the pathogenesis of CINM. In this study, smooth muscle preparations obtained from the colon of patients undergoing elective surgery were used to investigate the effects of serum from critically ill patients. At the time of blood draw, CINM was assessed by clinical rating and electrophysiology. Muscle strips were incubated with serum of healthy controls or patients in organ baths and isometric force was measured. Fifteen samples from healthy controls and 98 from patients were studied. Ratios of responses to electric field stimulation (EFS) before and after incubation were 118% for serum from controls and 51% and 62% with serum from critically ill patients obtained at day 3 and 10 of critical illness, respectively (p = 0.003, One-Way-ANOVA). Responses to carbachol and high-K+ were equal between these groups. Ratios of post/pre-EFS responses correlated with less severe CINM. These results support the existence of pathogenic, i.e. neurotoxic factors in the serum of critically ill patients. Using human colon smooth muscle as a bioassay may facilitate their future molecular identification.

Intraoperative Assessment of Gastric Sleeve Oxygenation Using Hyperspectral Imaging in Esophageal Resection: A Feasibility Study.

INTRODUCTION: Sufficient tissue oxygenation is essential for anastomotic healing in visceral surgery. Hyperspectral imaging (HSI) is a noncontact, noninvasive technique for clinical assessment of tissue oxygenation in real time. METHODS: In this case series, HSI was used in 4 patients who were admitted for either esophageal cancer or cardiac carcinoma (AEG type I or II). Thoraco-abdominal surgical esophageal resection was performed after staging and neoadjuvant therapy. Intraoperative oxygenation of superficial (StO2) and underlying tissue (NIR perfusion index) of the gastric sleeve were studied intrathoracic by means of the TIVITA® Tissue HSI camera. This was performed prior to esophagogastric anastomosis. The postoperative course, especially in view of surgical complications, was recorded. RESULTS: Assessment of StO2 and NIR perfusion index was performed in 4 regions of interest per gastric sleeve, aboral and oral of the clinically determined resection line. It allowed the fast quantification of gastric oxygenation prior gastroesophageal anastomosis. Median StO2 aboral of the determined resection line was 69%, while median StO2 in the oral part of the gastric sleeve was found at 53%. In contrast, the median NIR perfusion index was similar aboral (80) and oral (82) of the resection line. In none of the 4 studied patients, an anastomotic failure appeared. DISCUSSION/CONCLUSION: This report suggests that HSI is a feasible technique for intraoperative assessment of tissue oxygenation before gastroesophageal anastomosis and might reduce the incidence of anastomotic failure in the gastrointestinal tract.

Comparison Between Endoscopic Vacuum Therapy and Conventional Treatment for Leakage After Rectal Resection.

BACKGROUND: Anastomotic leakage after rectal resection represents a severe complication for the patient and requires an early and appropriate management. Endoscopic vacuum therapy (EVT) has become the treatment of choice for anastomotic leakage after rectal resection in several institutions in Germany, and commercially available systems are currently distributed in approximately 30 countries worldwide. However, there is no evidence that EVT is superior to any other treatment for anastomotic leakage after rectal resection. METHODS: Twenty-one patients treated with EVT for anastomotic leakage after rectal resection were retrospectively compared to a historical cohort of 41 patients that received conventional treatment. Primary endpoints were death, treatment success and long-term preservation of intestinal continuity. Secondary endpoints were length of hospital stay and duration of treatment. RESULTS: There was no difference in mortality (p = 0.624). The intention-to-treat analysis showed a significantly higher success rate of EVT compared to conventional treatment (95.2% vs. 65.9%, p = 0.011). EVT was associated with preservation of intestinal continuity in a significant higher percentage of patients than patients undergoing conventional treatment (86.7% vs. 37.5%, p = 0.001). Conventional treatment tended to a shorter length of hospital stay (31.1 vs. 42.2 days, p = 0.066) but with no difference in overall duration of treatment. Time until closing of a diverting stoma did not differ between groups (10.2 months in the EVT group vs. 9.4 months in the conventional treatment group, p = 0.721). CONCLUSION: According to this retrospective study, conventional therapy and EVT are both options for the treatment of anastomotic leakage after rectal resection. EVT might be more effective in terms of definite healing and preservation of intestinal continuity.

The Water-Holding Procedure for Ensuring Postoperative Continence Prior Restoring Intestinal Continuity.

BACKGROUND: A defunctioning stoma can become necessary in a relevant number of patients undergoing gastrointestinal surgery. As a matter of course, patients seek an early closure of the stoma. However, preoperative management of these patients varies and the prediction of continence after stoma removal can become challenging. Patients might be fully continent despite low manometric pressures and vice versa. An easy and reliable way to predict continence after stoma reversal would improve patients' management and outcome. Although frequently performed in various surgical centers in Germany, there is no published data on the water-holding test. Hence, this is the first study evaluating the role of the test in clinical practice. METHOD: We performed a prospective pilot study to evaluate the role of anorectal manometry and the water-holding procedure as a predictor of postoperative continence prior to stoma reversal. Inclusion criteria were a successfully passed water-holding test, any type of fecal diversion and the possibility of restoring intestinal continuity. Preoperative low manometric pressure levels were not an exclusion criteria for stoma reversal. Fifty-two patients with ostomy were consecutively enrolled in this study between October 2013 and February 2016. Anorectal manometry was performed in all patients prior to stoma reversal. After stoma removal, patients were followed-up for 6 months. Postoperative incontinence was determined using the Wexner incontinence score. RESULTS: A total of 52 patients (38 males, 14 females) were included at an average age of 59 (range 33-83) years. Most frequent indications for intestinal diversion were rectal cancer surgery, IBD-related surgery, or surgery for diverticular disease. Low anterior rectal resection was performed in 17 patients (32.7%), followed by a proctocolectomy in 9 (17.3%), colectomy in 9 (17.3%), and recto-sigmoid resection in 7 patients (13.5%). Median time from stoma creation to reversal was 206 days (range 48-871 days). All patients had successfully passed the standardized water-holding test. At the same time, the majority of patients had low preoperative manometric pressure values and would normally not have been reversed at that point. The median postoperative Wexner incontinence score was at 1.5 (range 0-20), 0.5 (range 0-14), and 0 (range 0-11) at 14, 60, and 180 days after stoma reversal. Low preoperative manometric squeeze and/or resting pressure levels were not associated with a higher postoperative incontinence score at 14, 60, or 180 days after stoma reversal. CONCLUSION: A standardized water-holding test can function as an easy and reliable method before stoma reversal to predict sufficient postoperative fecal continence. In case of a sufficient water-holding test despite low manometric pressure levels, the risk for postoperative anal incontinence seems to be low. Preoperative manometric pressure levels do not appear to predict postoperative continence.

Neoadjuvant radio-chemotherapy prolongs healing of anastomotic leakage after rectal resection treated with endoscopic vacuum therapy.

BACKGROUND: Neoadjuvant radiochemotherapy (nRCT) is an important component in the treatment of advanced rectal cancer. Endoscopic vacuum therapy (EVT) has become the treatment of choice for anastomotic leakage after rectal resection in many institutions in Germany. Published case series report on average success and stoma reversal rates of more than 80%. However, so far, there is no distinct report on the potential influence of nRCT on EVT. METHODS: A total of 11 patients treated with EVT for anastomotic leakage after nRCT and rectal resection were retrospectively compared with a cohort of eight patients with rectal anastomotic leakage without neoadjuvant treatment. Primary endpoints were death, treatment success, and long-term preservation of intestinal continuity. Secondary endpoint was the duration of treatment. Statistical analysis was performed using Statistical Package for Social Science (SPSS) version 23.0. RESULTS: There was no difference in mortality (0%), success rate (90.9% versus 100%, p = 0.381), or long-term preservation of continuity (63.6% versus 62.5%, p = 0.960). After nRCT, patients showed a significant longer duration of EVT (31.1 days versus 15.9 days, p = 0.040) which was associated with a significantly higher number of sponge applications (9.6 versus 5.0, p = 0.042). CONCLUSIONS: In our analysis, EVT showed success in over 90% of patients with anastomotic leakage after rectal resection for colorectal cancer, regardless of neoadjuvant treatment. However, in case of anastomotic leakage, nRCT seems to be associated with the need for a significant longer duration of EVT.

[Risk Factors for Early Surgery and Surgical Complications in Crohn's Disease]. / Risikofaktoren für einen frühen OP-Zeitpunkt und chirurgische Komplikationen bei Morbus Crohn.

BACKGROUND: In recent decades, developments in drug therapy have significantly postponed the need for surgery. Nevertheless, the majority of patients with Crohn's disease still require one or more surgical interventions during the course of their disease. An analysis of epidemiological data as well as the surgical results of our own patients should help to identify risk factors for early surgery, re-operations and perioperative complications. METHODS: A retrospective analysis including 120 consecutive patients with Crohn's disease and needing surgical intervention was carried out at the University Hospital of Rostock (UMR), Germany. Statistical analysis was performed using SPSS. RESULTS: A total of 284 operations were recorded in 120 patients, of which 207 were performed on the UMR. The mean age at first surgery was 38 years (range: 17 - 66); initial diagnosis of Crohn's was on average at the age of 30 (range: 9 - 62). Each patient was operated 2 - 3 times during the course of their disease (range 1 - 9). Patients older than 30 years had significantly shorter time interval to the first operation. The number of operations per patient was significantly influenced by the localisation and behaviour of the disease. Penetrative behavior was associated with more frequent operations and terminal ileum involvement (L1) with significantly less frequent operations. Risk factors for complication of at least grade III according to Clavien-Dindo included greater age at surgery and at first diagnosis, decreased albumin levels and increased CRP. Anastomotic leakages were also associated with these risk factors as well as preoperative intake of > 20 mg prednisolone equivalent per day or cumulative dosage of 280 mg over the last 14 days prior to surgery. Anastomosis configuration and microscopic involvement of the resection margins had no statistically significant influence on the development of anastomotic leakage. CONCLUSION: Diagnosis after the age of 30 was associated with a significantly earlier need for surgery in this analysis. Patients with terminal ileum involvement (L1) had a significantly lower surgical frequency than patients with colon or combined Crohn's disease. Age, albumin, CRP and a steroid medication > 20 mg per day were predictors for perioperative complications.

Before and after Anorectal Surgery: Which Information Is Needed from the Functional Laboratory?

BACKGROUND: Anorectal surgery covers a wide spectrum of surgery. Diagnostic workup of anorectal disease is based on clinical examination with basic functional tests followed by more elaborate diagnostic tests. Since the incidence of anorectal disorders increases with age, more patients will present in outpatient clinics, thus underlining the relevance of this topic. METHODS: A PubMed literature search was performed using the terms 'anal incontinence', 'anal and rectal surgery', 'functional diagnostics', and combinations of these terms. No restriction regarding publication year or publication type was applied but randomized trials, 'metanalyses', or guidelines were ranked higher. Only articles in English or German were included. RESULTS: The diagnostic value of digital rectal examination, anal manometry and endosonography, the water holding procedure, contrast enema, and incontinence scores is summarized. CONCLUSION: The article focusses on basic clinical and functional diagnostic tests which can be easily applied in the pre- and postoperative setting to evaluate the postoperative outcome.

Endoscopic Vacuum Therapy in Colorectal Surgery.

INTRODUCTION: Endoscopic vacuum therapy (EVT) has been established in Germany for the treatment of anastomotic leakage after rectal resection. Continuous or intermittent suction and drainage decrease bacterial contamination, secretion, and local edema promoting perfusion and granulation at the same time. However, data for use and long-term results of EVT in colorectal surgery are still scarce and are often limited by short-term follow-up. OBJECTIVES: Here, we aimed at analyzing the treatment spectrum and long-term outcome of EVT for defects of the lower gastrointestinal tract. METHODS: This is a retrospective single-center analysis of EVT for defects of the lower gastrointestinal tract of different etiology in 41 patients over a time period of 8 years (2007-2015) with a mean follow-up of 36 (2-89) months. RESULTS: In total, 426 polyurethane sponges were placed in lower GI defects of 41 patients (31 male, 10 female) with a median age of 70 years (range, 29-91). Most frequent indications for EVT were anastomotic leakage after rectal resection (n = 20), Hartmann's stump insufficiency (n = 12), and rectal perforation (n = 3). The median number of sponge insertions was six (range, 1-37) with a mean changing interval of 3 days (range, 1-5). Median time of therapy was 20 days. A successful vacuum therapy with local control of the septic focus was achieved in 18 of 20 patients (90 %) with anastomotic leakage after rectal resection and in nine of 12 patients with a Hartmann's stump insufficiency. In 15 of 19 (79 %) patients with a diverting stoma, take-down after successful treatment was possible. Median time to closure was 244 days (range, 152-488 days). CONCLUSION: To our knowledge, this retrospective observation of EVT application for rectal lesions represents the largest patient series in literature. EVT has earned its indication in complication management after colorectal surgery and can achieve a successful control of a local septic focus in the majority of patients.

Surgical Endoscopic Vacuum Therapy for Defects of the Upper Gastrointestinal Tract.

INTRODUCTION: Intraluminal therapy used in the gastrointestinal (GI) tract was first shown for anastomotic leaks after rectal resection. Since a few years vacuum sponge therapy is increasingly being recognized as a new promising method for repairing upper GI defects of different etiology. The principles of vacuum-assisted closure (VAC) therapy remain the same no matter of localization: Continuous or intermittent suction and drainage decrease bacterial contamination, secretion, and local edema. At the same time, perfusion and granulation is promoted. However, data for endoscopic vacuum therapy (EVT) of the upper intestinal tract are still scarce and consist of only a few case reports and small series with low number of patients. OBJECTIVES: Here, we present a single center experience of EVT for substantial wall defects in the upper GI tract. METHODS: Retrospective single-center analysis of EVT for various defects of the upper GI tract over a time period of 4 years (2011-2015) with a mean follow-up of 17 (2-45) months was used. If necessary, initial endoscopic sponge placement was performed in combination with open surgical revision. RESULTS: In total, 126 polyurethane sponges were placed in upper gastrointestinal defects of 21 patients with a median age of 72 years (range, 49-80). Most frequent indication for EVT was anastomotic leakage after esophageal or gastric resection (n = 11) and iatrogenic esophageal perforation (n = 8). The median number of sponge insertions was five (range, 1-14) with a mean changing interval of 3 days (range, 2-4). Median time of therapy was 15 days (range, 3-46). EVT in combination with surgery took place in nine of 21 patients (43 %). A successful vacuum therapy for upper intestinal defects with local control of the septic focus was achieved in 19 of 21 patients (90.5 %). CONCLUSION: EVT is a promising approach for postoperative, iatrogenic, or spontaneous lesions of the upper GI tract. In this series, EVT was combined with operative revision in a relevant proportion of patients.

Treatment of necrotizing pancreatitis: redefining the role of surgery.

BACKGROUND: Early surgical intervention in necrotizing pancreatitis (NP) is associated with high mortality. Guidelines recommend fine needle aspiration (FNA) in patients with NP and signs of sepsis. Because infection of necrosis is considered an indication for surgery, operations are often performed early. We changed treatment toward a conservative approach with FNA in selected cases only, thereby reducing the rate of necrosectomy. METHODS: Retrospectively analyzed patients, all operated on for FNA-proven infection of pancreatic necrosis (n = 20, group 1) were compared to patients subjected to conservative treatment (n = 24, group 2) who were followed prospectively. RESULTS: Prognostic scores did not differ between the two groups, indicating comparable severity: the Acute Physiology and Chronic Health Evaluation (APACHE II) score was 19.8 ± 1.7 versus 16 ± 2.2; the Sequential Organ Failure Assessment (SOFA) score was 8.7 ± 1.4 versus 6.9 ± 1.0, the C-reactive protein (CRP) level on day 3 was 243 ± 21 versus 291 ± 21, and the CTSI (CT severity index) was 7.8 ± 0.5 versus 7.9 ± 0.4 (p = ns). Ten patients in group 2 underwent operation because of severe extrapancreatic complications. Mortality differed significantly (45% in group 1 vs. 8.3% in group 2; p = 0.01). CONCLUSIONS: A highly conservative approach avoiding open necrosectomy in NP results in significantly lower mortality than previous serial FNA and consecutive indication for surgery in case of proven infection. Open surgery in NP should be reserved for concomitant intra-abdominal complications.