Surgical options in retrosternal oesophageal reconstruction.

BACKGROUND: Retrosternal oesophageal reconstructions with collar anastomoses can become necessary when the stomach is either unavailable for oesophageal replacement, or orthotopic reconstruction is deemed impractical. Our aim was to analyse our results regarding technical approaches and outcomes. MATERIALS AND METHODS: All patients undergoing primary and secondary oesophageal retrosternal reconstructions with collar anastomoses at our centre (2019-2023) were retrospectively analysed and individual surgical reconstruction options were presented. RESULTS: Overall, twelve patients received primary (n = 5; 42.7%) or secondary (n = 7; 58.3%) reconstructions; ten with colonic interposition and two with gastric pull-up. Male/female ratio was 4:8; median age 66 years (30-87). Charlson-Comorbidity-Score (CCS) was 5 (1-7); 8/12 patients (67%) had ASA-classification score ≥ 3. We observed no conduit necrosis, but one patient (8.3%) with a leakage of the oesophago-colonostomy which was successfully treated by endoscopic vacuum therapy. Four patients (33.3%) acquired nosocomial pneumonia. Additional drainages for pleural fluid collections were necessary in three patients (25%). Overall comprehensive-complication-index (CCI) was 26.2 (0-44.9). Length-of-stay (LOS) was 22 days median (15-40). There was no 90-days mortality. Overall, CCI during the follow-up (FU) period at median 26 months (16-50) was 33.7 (0-100). 10 out of 12 patients were on sufficient oral nutrition at 12 months FU. CONCLUSION: Primary and secondary oesophageal retrosternal reconstructions encompass diverse entities and typically requires tailored decision-making. These procedures, though rare, are feasible with acceptable complication rates and positive functional outcomes when performed in experienced hands.

Nationwide volume-outcome relationship concerning in-hospital mortality and failure-to-rescue in surgery of sigmoid diverticulitis.

PURPOSE: A correlation between the hospital volume and outcome is described for multiple entities of oncological surgery. To date, this has not been analyzed for the surgical treatment of sigmoid diverticulitis. The aim of this study was to explore the impact of the annual caseload per hospital of colon resection on the postoperative incidence of complications, failure to rescue, and mortality in patients with diverticulitis. METHODS: Patients receiving colorectal resection independent from the diagnosis from 2012 to 2017 were selected from a German nationwide administrative dataset. The hospitals were grouped into five equal caseload quintiles (Q1-Q5 in ascending caseload order). The outcome analysis was focused on patients receiving surgery for sigmoid diverticulitis. RESULTS: In total, 662,706 left-sided colon resections were recorded between 2012 and 2017. Of these, 156,462 resections were performed due to sigmoid diverticulitis and were included in the analysis. The overall in-house mortality rate was 3.5%, ranging from 3.8% in Q1 (mean of 9.5 procedures per year) to 3.1% in Q5 (mean 62.8 procedures per year; p < 0.001). Q5 hospitals revealed a risk-adjusted odds ratio of 0.85 (95% CI 0.78-0.94; p < 0.001) for in-hospital mortality compared to Q1 during multivariable logistic regression analysis. High-volume centers showed overall lower complication rates, whereas the failure-to-rescue did not differ significantly. CONCLUSION: Surgical treatment of sigmoid diverticulitis in high-volume colorectal centers shows lower postoperative mortality rates and fewer postoperative complications.

Diverticulitis patient care during the Covid-19 pandemic in Germany-a retrospective nationwide population-based cohort study.

PURPOSE: Coronavirus disease 2019 (COVID-19) impacted health care systems around the world. Despite a decrease in emergency admissions, an increased number of complicated forms of diverticulitis was reported. It was the aim of this study to analyze the pandemic impact on diverticulitis management in Germany. METHODS: This is a retrospective population-wide analysis of hospital billing data (2012-2021) of diverticulitis in Germany. Patients were identified based on diagnosis (ICD10) and procedural codes to stratify by conservative and operative management. Primary outcome of interest was admission rates, secondary outcomes were rates of surgical vs conservative treatment and fraction of complicated clinical courses during the pandemic. RESULTS: Of a total of 991,579 cases, 66,424 (6.7%) were admitted during pandemic lockdowns. Conservative treatment was the most common overall (66.9%) and higher during lockdowns (70.7%). Overall admissions and population adjusted rates of surgically treated patients decreased, the latter by 12.7% and 11.3%, corrected to estimated rates, in the two lockdowns. Surgery after emergency presentation decreased by 7.1% (p=0.053) and 11.1% (p=0.002) in the two lockdowns with a higher rate of ostomy and/or revision (+5.6%, p=0.219, and +10.2%, p=0.030). In-hospital mortality was increased in lockdown periods (1.64% vs 1.49%). In detail, mortality was identical in case of conservative treatment during lockdown periods (0.5%) but was higher in surgically treated patients (4.4% vs 3.6%). CONCLUSION: During lockdowns, there was an overall decrease of admissions for diverticulitis, especially non-emergency admissions in Germany, and treatment was more likely to be conservative. In case of surgery, however, there was increased risk of a complicated course (ostomy, re-surgery), possibly due to patient selection.

Risk-adjusted perioperative bridging anticoagulation reduces bleeding complications without increasing thromboembolic events in general and visceral surgery.

BACKGROUND: Perioperative bridging of oral anticoagulation increases the risk of bleeding complications after elective general and visceral surgery. The aim of this study was to explore, whether an individual risk-adjusted bridging regimen can reduce bleeding events, while still protecting against thromboembolic events. METHODS: We performed a quality improvement study comparing bridging parameters and postoperative outcomes before (period 1) and after implementation (period 2) of a new risk-adjusted bridging regimen. The primary endpoint of the study was overall incidence of postoperative bleeding complications during 30 days postoperatively. Secondary endpoints were major postoperative bleeding, minor bleeding, thromboembolic events, postoperative red blood cell transfusion, perioperative length-of-stay (LOS) and in-hospital mortality. RESULTS: A total of 263 patients during period 1 and 271 patients during period 2 were compared. The included elective operations covered the entire field of general and visceral surgery. The overall incidence of bleeding complications declined from 22.1% during period 1 to 10.3% in period 2 (p < 0.001). This reduction affected both major as well as minor bleeding events (8.4% vs. 4.1%; p = 0.039; 13.7% vs. 6.3%; p = 0.004). The incidence of thromboembolic events remained low (0.8% vs. 1.1%). No changes in mortality or length-of-stay were observed. CONCLUSION: It is important to balance the individual thromboembolic and bleeding risks in perioperative bridging management. The risk adjusted bridging regimen reduces bleeding events in general and visceral surgery while the risk of thromboembolism remains comparably low.

Does Concurrent Cholestasis Alter the Prognostic Value of Preoperatively Elevated CA19-9 Serum Levels in Patients with Pancreatic Head Adenocarcinoma?

BACKGROUND: Pancreatic adenocarcinoma (PDAC) patients with preoperative carbohydrate antigen 19-9 (CA19-9) serum levels higher than 500 U/ml are classified as biologically borderline resectable (BR-B). To date, the impact of cholestasis on preoperative CA19-9 serum levels in these patients has remained unquantified. METHODS: Data on 3079 oncologic pancreatic resections due to PDAC that were prospectively acquired by the German Study, Documentation and Quality (StuDoQ) registry were analyzed in relation to preoperative CA19-9 and bilirubin serum values. Preoperative CA19-9 values were adjusted according to the results of a multivariable linear regression analysis of pathologic parameters, bilirubin, and CA19-9 values. RESULTS: Of 1703 PDAC patients with tumor located in the pancreatic head, 420 (24.5 %) presented with a preoperative CA19-9 level higher than 500 U/ml. Although receiver operating characteristics (ROC) analysis failed to determine exact CA19-9 cut-off values for prognostic indicators (R and N status), the T, N, and G status; the UICC stage; and the number of simultaneous vein resections increased with the level of preoperative CA19-9, independently of concurrent cholestasis. After adjustment of preoperative CA19-9 values, 18.5 % of patients initially staged as BR-B showed CA19-9 values below 500 U/ml. However, the postoperative pathologic results for these patients did not change compared with the patients who had CA19-9 levels higher than 500 U/ml after bilirubin adjustment. CONCLUSIONS: In this multicenter dataset of PDAC patients, elevation of preoperative CA19-9 correlated with well-defined prognostic pathologic parameters. Bilirubin adjustment of CA19-9 is feasible but does not affect the prognostic value of CA19-9 in jaundiced patients.

Differences in morbidity and mortality between unilateral adrenalectomy for adrenal Cushing's syndrome and bilateral adrenalectomy for therapy refractory extra-adrenal Cushing's syndrome.

PURPOSE: In selected cases of severe Cushing's syndrome due to uncontrolled ACTH secretion, bilateral adrenalectomy appears unavoidable. Compared with unilateral adrenalectomy (for adrenal Cushing's syndrome), bilateral adrenalectomy has a perceived higher perioperative morbidity. The aim of the current study was to compare both interventions in endogenous Cushing's syndrome regarding postoperative outcomes. METHODS: We report a single-center, retrospective cohort study comparing patients with hypercortisolism undergoing bilateral vs. unilateral adrenalectomy during 2008-2021. Patients with adrenal Cushing's syndrome due to adenoma were compared with patients with ACTH-dependent Cushing's syndrome (Cushing's disease and ectopic ACTH production) focusing on postoperative morbidity and mortality as well as long-term survival. RESULTS: Of 83 patients with adrenalectomy for hypercortisolism (65.1% female, median age 53 years), the indication for adrenalectomy was due to adrenal Cushing's syndrome in 60 patients (72.2%; 59 unilateral and one bilateral), and due to hypercortisolism caused by Cushing's disease (n = 16) or non-pituitary uncontrolled ACTH secretion of unknown origin (n = 7) (27.7% of all adrenalectomies). Compared with unilateral adrenalectomy (n = 59), patients with bilateral adrenalectomy (n = 24) had a higher rate of severe complications (0% vs. 33%; p < 0.001) and delayed recovery (median: 10.2% vs. 79.2%; p < 0.001). Using the MTL30 marker, patients with bilateral adrenalectomy fared worse than patients after unilateral surgery (MTL30 positive: 7.2% vs. 25.0% p < 0.001). Postoperative mortality was increased in patients with bilateral adrenalectomy (0% vs. 8.3%; p = 0.081). CONCLUSION: While unilateral adrenalectomy for adrenal Cushing's syndrome represents a safe and definitive therapeutic option, bilateral adrenalectomy to control ACTH-dependent extra-adrenal Cushing's syndrome or Cushing's disease is a more complicated intervention with a mortality of nearly 10%.

Impact of Borderline Resectability in Pancreatic Head Cancer on Patient Survival: Biology Matters According to the New International Consensus Criteria.

BACKGROUND: International consensus criteria (ICC) have redefined borderline resectability for pancreatic ductal adenocarcinoma (PDAC) according to three dimensions: anatomical (BR-A), biological (BR-B), and conditional (BR-C). The present definition acknowledges that resectability is not just about the anatomic relationship between the tumour and vessels but that biological and conditional dimensions also are important. METHODS: Patients' tumours were retrospectively defined borderline resectable according to ICC. The study cohort was grouped into either BR-A or BR-B and compared with patients considered primarily resectable (R). Differences in postoperative complications, pathological reports, overall (OS), and disease-free survival were assessed. RESULTS: A total of 345 patients underwent resection for PDAC. By applying ICC in routine preoperative assessment, 30 patients were classified as stage BR-A and 62 patients as stage BR-B. In total, 253 patients were considered R. The cohort did not contain BR-C patients. No differences in postoperative complications were detected. Median OS was significantly shorter in BR-A (15 months) and BR-B (12 months) compared with R (20 months) patients (BR-A vs. R: p = 0.09 and BR-B vs. R: p < 0.001). CA19-9, as the determining factor of BR-B patients, turned out to be an independent prognostic risk factor for OS. CONCLUSIONS: Preoperative staging defining surgical resectability in PDAC according to ICC is crucial for patient survival. Patients with PDAC BR-B should be considered for multimodal neoadjuvant therapy even if considered anatomically resectable.

[The Impact of Lockdown during the COVID-19 Pandemic on Care for Elective Patients (C-elective Study) - Results of a Multicenter Survey]. / Die Auswirkung des Lockdowns während der COVID-19-Pandemie auf die Versorgung von elektiven Patienten (C-elective-Studie).

BACKGROUND: Due to the COVID-19-related lockdown regulations, surgical clinics had to cut down elective procedures. The impact of the cancellation and postponing surgery on patients is unclear. METHODS: All patients from six hospitals with canceled surgery during the first lockdown (03/16-04/24/2020) were asked to answer a questionnaire. RESULTS: In total, 225 patients took part. In 88 (39.1%) patients, the disease-related complaints changed, mainly towards an increase in severity (82.6%). That was especially true for hernia patients (44.4%). In 4% of the cases, there was a complication requiring surgery in the time interval between the original date of the operation and the interview. For about a third, the cancelation of scheduled surgery caused major administrative difficulties. Most of the patients (76.3%) understood the measures taken, though 40.4% of them considered that their indication was very urgent. DISCUSSION AND CONCLUSION: The overall complication rate was low, and patients agreed to the measures taken; however, especially hernia patients showed increasing symptoms and some acute incarcerations. It seems reasonable to monitor symptomatic patients closely, in order to prioritise them when surgical capacity is restricted.

[Prevention of Surgical Site Infections]. / Prävention postoperativer Wundinfektionen.

The burden of surgical site infections (SSIs) is increasing. The number of surgical procedures continues to rise, and surgical patients present increasingly complex comorbidities. Half of SSIs are deemed preventable using evidence-based strategies. It is recommended for patients to bathe or shower prior to surgery. Hair should be removed only with a clipper. Shaving is strongly discouraged at all times. Antimicrobial prophylaxis should be administered only when indicated, based on guidelines, and timed correctly in order to achieve a bactericidal concentration in the tissues when the incision is made. Prophylaxis must not be continued beyond surgery. For skin preparation in the operating room an alcohol-based agent plus chlorhexidine or octenidine is recommended. During surgery, glycemic control and goal-directed fluid therapy should be implemented. Normothermia should be targeted in all patients. The perioperative use of an increased fraction of inspired oxygen may reduce the risk of SSI. Using a surgical safety checklist during a team time-out immediately before surgery reduces the incidence of SSI.

[Classification of Acute Diverticulitis for Stage-directed Therapy]. / Stadiengerechte Therapie der akuten Divertikulitis anhand der neuen Klassifikation der Divertikelkrankheit.

BACKGROUND: In recent years, there has been a significant change in the treatment recommendations for acute diverticulitis. In order to provide the right treatment to the individual patient, it is therefore important to classify the stage of the disease accurately, after taking various aspects into consideration. METHODS: Patients treated for acute diverticulitis in Würzburg University Hospital during 2010 to 2014 were included. Inclusion criteria were the presence of a computer tomography for disease classification. RESULTS: More than half of the patients examined (n = 135, 52.9%) had acute uncomplicated diverticulitis on admission; 112 (43.2%) had a covered perforation (small paracolic abscess n = 63, 24,3%; large abscess n = 49, 18,9%) and 12 (4.6%) a free perforation. In a total of 150 (57.9%) patients, this was the first episode of diverticulitis, with a covered (66.1%) or a free perforation (75.0%) occurring at a higher than average rate as the first manifestation. Nearly two-thirds (66.4%, n = 168) of patients underwent sigmoid resection during follow-up. DISCUSSION AND CONCLUSION: Despite current trends towards more conservative therapy of acute diverticulitis, sigmoid resection remains a corner stone of successful therapy throughout all types of acute diverticulitis. The indication of sigmoid resection nowadays requires profound knowledge of the individual prognosis for recurrent diverticulitis and quality of life.

Preliminary study on liver function changes after trisectionectomy with versus without prior portal vein embolization.

PURPOSE: Post-hepatectomy liver failure (PHLF) is the major risk factor for mortality after hepatectomy. Preoperative planning of the future liver remnant volume reduces PHLF rates; however, future liver remnant function (FLR-F) might have an even stronger predictive value. In this preliminary study, we used a new method to calculate FLR-F by the LiMAx test and computer tomography-assisted volumetric-analysis to visualize liver function changes after portal vein embolization (PVE) before extended hepatectomy. METHODS: The subjects included patients undergoing extended right hepatectomy either directly (NO-PVE group) or after PVE (PVE group). Computed tomography (CT) scan and liver function tests (LiMAx) were done before PVE and preoperatively. FLR-F was calculated and correlated with the postoperative liver function. RESULTS: There were 12 patients in the NO-PVE group and 19 patients in the PVE group. FLR-F and postoperative liver function correlated significantly in both groups (p = 0.036, p = 0.011), although postoperative liver function was slightly overestimated, at 32 and 45 µg/kg/min, in the NO-PVE and PVE groups, respectively. LiMAx value did not change after PVE. CONCLUSIONS: Volume-function analysis using LiMAx and CT scan enables us to reliably predict early postoperative liver function. Global enzymatic liver function measured by the LiMAx test did not change after PVE, confirming that liver function distribution in the liver stays constant after PVE. An overestimation of FLR-F is needed to compensate for the intraoperative liver injury that occurs in patients undergoing extended hepatectomy.

Reliable assessment of liver function using LiMAx.

BACKGROUND: (13)C-liver function breath tests can facilitate the assessment of hepatic function in-vivo and may help surgeons to identify candidates for safe liver surgery. However, their acceptance into clinical practice is dependent on evaluation of technical efficacy and repeatability. The aims of this study were to evaluate the within-subject repeatability of the LiMAx (maximum liver function capacity) test in healthy individuals and in surgical patients to determine liver function in the perioperative workup. MATERIAL AND METHODS: The LiMAx test, which is based on intravenous injection of (13)C-methacetin at a dosage of 2 mg/kg body weight was performed in eighty-six healthy subjects to determine a reference range. Twenty-four subjects underwent repeat LiMAx testing the following day to assess within-subject repeatability. Twenty-one patients undergoing elective extra-abdominal surgery under general anesthesia (GA group) received pre- and post-operative examinations. RESULTS: The normal range of LiMAx was found to be 430 ± 86 µg/kg/h and revealed a one-sided cut-off value of 315 µg/kg/h. The intraclass correlation coefficient of the repeat LiMAx tests was 0.85 (95% confidence interval 0.69-0.93) in the control group and 0.81 (95% confidence interval 0.60-0.92) in the group of patients with GA. CONCLUSIONS: The LiMAx test shows excellent reproducibility in subjects with normal liver function. GA has no effect on test results.

Growth hormone/insulin-like growth factor 1 dynamics in adult living donor liver transplantation.

End-stage liver disease is accompanied by decreased serum levels of insulin-like growth factor 1 (IGF1) and inversely increased serum levels of growth hormone (GH). Previous reports have demonstrated rapid GH/IGF1 axis recovery after orthotopic liver transplantation. This study investigated the effect in an adult-to-adult living donor liver transplantation (LDLT) model and characterized GH/IGF1 alterations and liver regeneration in both donors and recipients. Sequential blood samples were prospectively collected from 30 donor-recipient pairs during the perioperative course of LDLT. A distinct set of biochemical parameters, including serum GH, serum IGF1, and standard liver blood tests, was analyzed at different time points (preoperatively and during 12 months of follow-up after surgery). Recipients showed significantly higher GH serum levels and lower IGF1 serum levels in comparison with donors before surgery and throughout the first postoperative days (PODs). The GH serum levels of recipients declined, whereas donor levels inversely increased during the early postoperative period to a normal range. Recipients' IGF1 serum levels were restored within the first operative week. In parallel, donor IGF1 levels decreased by 50% after living donation, and preoperative serum levels were restored after 6 months. Donors showed delayed recovery of liver function in comparison with recipients. The dynamics of IGF1 strongly correlated with routine laboratory parameters of liver function. In conclusion, recipients showed a rapid recovery of the GH/IGF1 hormonal axis and liver function after LDLT, whereas donors showed altered GH signaling and regenerative delay in the early PODs after living donation.

CT-guided high-dose-rate brachytherapy of liver tumours does not impair hepatic function and shows high overall safety and favourable survival rates.

BACKGROUND OR PURPOSE: Computed tomography-guided high-dose-rate brachytherapy (CT-HDRBT) is an emerging therapeutic option for irresectable liver tumours. However, its potentially negative effect on liver function has not yet been investigated. The aim of this study was to evaluate CT-HDRBT for potential liver damage and functional impairment by means of quantitative liver function tests, patient safety, and survival. METHODS: Sixty-nine patients receiving hepatic CT-HDRBT were investigated in a prospective study. The liver function was determined before and after intervention, and 6 and 12 weeks later. The study visits included liver function assessment by conventional biochemical parameters, the liver function capacity test based on 13C-Methacetin (MA) kinetics in µg/kg/hr (LiMAx test), and the indocyanine green plasma disappearance rate test. Tumour progression was re-staged by magnetic resonance imaging (MRI) twice. The 2-year-survival was analysed. RESULTS: A significant alteration of biochemical liver parameters was observed for liver enzymes and bilirubin directly after intervention, all biochemical parameters had normalised at the 6-week follow-up. There were no changes in LiMAx test values after the intervention, showing no effect on metabolic liver function capacity. In approximately two-thirds of the patients, MRI re-staging revealed a significant tumour response, and no local tumour recurrence occurred. No patient developed a radiation-induced liver disease. CONCLUSION: CT-HDRBT for local tumour treatment has little impact on total liver function capacity by high patient safety and encouraging survival rates. Thus, it should be an important option in treating patients without a surgical alternative, especially when liver function is impaired due to previous surgery or chronic liver disease.

Enzymatic liver function capacity correlates with disease severity of patients with liver cirrhosis: a study with the LiMAx test.

BACKGROUND: Assessment and quantification of actual liver function is crucial in patients with chronic liver disease to monitor disease progression and predict individual prognosis. Mathematical models, such as model for end-stage liver disease, are used for risk stratification of patients with chronic liver disease but do not include parameters that reflect the actual functional state of the liver. AIM: We aimed to evaluate the potential of a (13)C-based liver function test as a stratification tool by comparison with other liver function tests and clinical parameters in a large sample of healthy controls and cirrhotic patients. METHODS: We applied maximum liver function capacity (LiMAx) to evaluate actual liver function in 347 patients with cirrhosis and in 86 controls. RESULTS: LiMAx showed strong negative correlation with Child-Pugh Score (r = -0.707; p < 0.001), MELD (r = -0.686; p < 0.001) and liver function tests. LiMAx was lower in patients with liver cirrhosis compared to healthy controls [99 (57-160) µg/kg/h vs. 412 (365-479) µg/kg/h, p < 0.001] and differed among Child-Pugh classes [a: 181 (144-227) µg/kg/h, b: 96 (62-132) µg/kg/h and c: 52 (37-81) µg/kg/h; p < 0.001]. When stratified patients according to disease severity, LiMAx results were not different between cirrhotic patients and cirrhotic patients with transjugular intrahepatic portosystemic shunt. CONCLUSIONS: LiMAx appears to provide reliable information on remnant enzymatic liver function in chronic liver disease and allows graduation of disease severity.

Accidentally ingested toothpicks causing severe gastrointestinal injury: a practical guideline for diagnosis and therapy based on 136 case reports.

BACKGROUND: Ingested toothpicks are a relatively rare event, but may cause serious gut injuries with peritonitis, sepsis, or death. Numerous case reports describing the clinical course in this setting are available but there is no concise guideline. The aim of the present study was to develop practical guidelines to aid clinicians in the diagnosis and management of acute tooth pick ingestion. METHOD: Our Medline search identified 116 publications containing case reports of ingested toothpicks. We then performed a retrospective analysis of patients' characteristics, medical history, diagnostics, therapy, and clinical outcome. RESULTS: A total of 136 cases (74 % male, age 52 [5-92] years) have been reported in the literature. From the available information, more than 50 % (n = 48) of patients were not aware of having swallowed a toothpick. The most common presenting symptoms were abdominal pain (82 %), fever (39 %), and nausea (31 %). The toothpick caused gut perforation in 79 % of all patients. The locations of toothpicks prior removal were esophagus (2 %), stomach (20 %), duodenum (23 %), small intestine (18 %), and large intestine (37 %). The diagnostic procedures included endoscopy (63 %), computed tomography scan (63 %), and ultrasound (47 %); however, in 35 % of cases these investigations failed to detect the toothpick. Therapy was surgery in most cases (58 %). The overall mortality was 9.6 %. CONCLUSIONS: Toothpick ingestion is a medical emergency. Perforations of the intestine are common and the associated mortality is high. Adequate therapy depends on localization of the toothpick in the gastrointestinal tract. Ingested toothpicks should be kept in mind as an important differential diagnosis in patients with acute abdomen.

Intraoperative Wound Irrigation for the Prevention of Surgical Site Infection After Laparotomy: A Randomized Clinical Trial by CHIR-Net.

Importance: Surgical site infections frequently occur after open abdominal surgery. Intraoperative wound irrigation as a preventive measure is a common practice worldwide, although evidence supporting this practice is lacking. Objective: To evaluate the preventive effect of intraoperative wound irrigation with polyhexanide solution. Design, Setting, and Participants: The Intraoperative Wound Irrigation to Prevent Surgical Site Infection After Laparotomy (IOWISI) trial was a multicenter, 3-armed, randomized clinical trial. Patients and outcome assessors were blinded to the intervention. The clinical trial was conducted in 12 university and general hospitals in Germany from September 2017 to December 2021 with 30-day follow-up. Adult patients undergoing laparotomy were eligible for inclusion. The main exclusion criteria were clean laparoscopic procedures and the inability to provide consent. Of 11 700 screened, 689 were included and 557 completed the trial; 689 were included in the intention-to-treat and safety analysis. Interventions: Randomization was performed online (3:3:1 allocation) to polyhexanide 0.04%, saline, or no irrigation (control) of the operative wound before closure. Main Outcome and Measures: The primary end point was surgical site infection within 30 postoperative days according to the US Centers for Disease Control and Prevention definition. Results: Among the 689 patients included, 402 were male and 287 were female. The median (range) age was 65.9 (18.5-94.9) years. Participants were randomized to either wound irrigation with polyhexanide (n = 292), saline (n = 295), or no irrigation (n = 102). The procedures were classified as clean contaminated in 92 cases (8%). The surgical site infection incidence was 11.8% overall (81 of 689), 10.6% in the polyhexanide arm (31 of 292), 12.5% in the saline arm (37 of 295), and 12.8% in the no irrigation arm (13 of 102). Irrigation with polyhexanide was not statistically superior to no irrigation or saline irrigation (hazard ratio [HR], 1.23; 95% CI, 0.64-2.36 vs HR, 1.19; 95% CI, 0.74-1.94; P = .47). The incidence of serious adverse events did not differ among the 3 groups. Conclusions and Relevance: In this study, intraoperative wound irrigation with polyhexanide solution did not reduce surgical site infection incidence in clean-contaminated open abdominal surgical procedures compared to saline or no irrigation. More clinical trials are warranted to evaluate the potential benefit in contaminated and septic procedures, including the emergency setting. Trial Registration: drks.de Identifier: DRKS00012251.

Predicting the prognosis in acute liver failure: results from a retrospective pilot study using the LiMAx test.

BACKGROUND: Acute liver failure (ALF) is a rare but potentially life-threatening condition and liver transplantation (LTX) remains frequently the only effective therapy. Nevertheless, some patients recover without LTX but the individual indication for or against LTX remains difficult. AIM: To evaluate maximal liver function capacity (LiMAx) for predicting the prognosis of ALF. Material and methods. Clinic data of 12 patients was retrospectively analyzed to compare the different liver function test results with the patients' clinical outcome. Patients were assessed by the LiMAx test, a non-invasive breath test determining cytochrome P450 1A2 capacity using intravenous 13C-methacetin. Statistical analysis compared patients with spontaneous recovery versus non-recovery (LTX or death). RESULTS: Twelve patients (6 male, 6 female; 49 [11-72] years) with viral hepatitis (n = 2), toxic liver injury (n = 3), or cryptogenic liver failure (n = 7) were analyzed. Seven patients fully recovered from ALF and were discharged without LTX. Three patients died and two underwent LTX. The King's College Criteria (KCC) was fulfilled in only one out of five patients without recovery. The LiMAx was 19 ± 19 (16-62) for non-recovery vs. 94 ± 119 (39-378) µg/kg/h for recovery (P = 0.018). In contrast, all biochemical parameters [bilirubin (P = 0.106), creatinine (P = 0.343), AST (P = 0.53), ALT (P = 0.876) and INR (P = 0.876) were statistically indistinct. Also the Model for End-Stage Liver Disease (MELD) score did not show a difference [35 ± 4.3 (29-40) vs. 30 ± 11.5 (6-40); P = 0.27]. CONCLUSIONS: Maximal liver function capacity determined by LiMAx test is severely impaired in patients with ALF. The LiMAx test might be effective in predicting the individual prognosis and the need for LTX in ALF.