Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial.

BACKGROUND: The standard curative treatment for patients with esophageal cancer is perioperative chemotherapy or preoperative chemoradiotherapy followed by open transthoracic esophagectomy (OTE). Robot-assisted minimally invasive thoracolaparoscopic esophagectomy (RAMIE) may reduce complications. METHODS: A single-center randomized controlled trial was conducted, assigning 112 patients with resectable intrathoracic esophageal cancer to either RAMIE or OTE. The primary endpoint was the occurrence of overall surgery-related postoperative complications (modified Clavien-Dindo classification grade 2-5). RESULTS: Overall surgery-related postoperative complications occurred less frequently after RAMIE (59%) compared to OTE (80%) [risk ratio with RAMIE (RR) 0.74; 95% confidence interval (CI), 0.57-0.96; P = 0.02]. RAMIE resulted in less median blood loss (400 vs 568 mL, P <0.001), a lower percentage of pulmonary complications (RR 0.54; 95% CI, 0.34-0.85; P = 0.005) and cardiac complications (RR 0.47; 95% CI, 0.27-0.83; P = 0.006) and lower mean postoperative pain (visual analog scale, 1.86 vs 2.62; P < 0.001) compared to OTE. Functional recovery at postoperative day 14 was better in the RAMIE group [RR 1.48 (95% CI, 1.03-2.13; P = 0.038)] with better quality of life score at discharge [mean difference quality of life score 13.4 (2.0-24.7, p = 0.02)] and 6 weeks postdischarge [mean difference 11.1 quality of life score (1.0-21.1; P = 0.03)]. Short- and long-term oncological outcomes were comparable at a medium follow-up of 40 months. CONCLUSIONS: RAMIE resulted in a lower percentage of overall surgery-related and cardiopulmonary complications with lower postoperative pain, better short-term quality of life, and a better short-term postoperative functional recovery compared to OTE. Oncological outcomes were comparable and in concordance with the highest standards nowadays.

Changes after transformation from a specialized surgical unit to a general mixed intensive care unit.

OBJECTIVES: We report the transition of a specialized surgical intensive care unit to a general mixed intensive care unit (ICU) and its influence on immediate outcome and performance data of the surgical population before and after the reorganization. METHODS: All consecutive patients (2420 admissions) entering the surgical intensive care unit, period 2004-2007. After the year 2005, all specialized units were combined into 3 general mixed units. RESULTS: Our population on the former surgical unit changed from mostly surgical patients to a mixed general ICU population, which comprises mostly of cardiac surgery patients. We saw better results in all overall outcome domains (ICU mortality, length of stay, and percentage of ICU readmissions). The ICU standardized mortality ratio remained the same. Surgical patients' outcome did not improve, nor did it decrease after the organizational change. CONCLUSION: Organizational changes from a surgical ICU to a general mixed unit can have profound influences on performance data. Crude ICU outcome improved after the reorganization. Nevertheless, ICU standardized mortality ratio did not change.

Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial).

BACKGROUND: For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer. METHODS/DESIGN: This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥ 18 and ≤ 80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications. DISCUSSION: This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790.

Oral decontamination with chlorhexidine reduces the incidence of ventilator-associated pneumonia.

RATIONALE: Ventilator-associated pneumonia (VAP) is the most frequently occurring nosocomial infection associated with increased morbidity and mortality. Although oral decontamination with antibiotics reduces incidences of VAP, it is not recommended because of potential selection of antibiotic-resistant pathogens. We hypothesized that oral decontamination with either chlorhexidine (CHX, 2%) or CHX/colistin (CHX/COL, 2%/2%) would reduce and postpone development of VAP, and oral and endotracheal colonization. OBJECTIVES: To determine the effect of oral decontamination with CHX or CHX/COL on VAP incidence and time to development of VAP. METHODS: Consecutive patients needing mechanical ventilation for 48 h or more were enrolled in a randomized, double-blind, placebo-controlled trial with three arms: CHX, CHX/COL, and placebo (PLAC). Trial medication was applied every 6 h into the buccal cavity. Oropharyngeal swabs were obtained daily and quantitatively analyzed for gram-positive and gram-negative microorganisms. Endotracheal colonization was monitored twice weekly. RESULTS: Of 385 patients included, 130 received PLAC, 127 CHX and 128 CHX/COL. Baseline characteristics were comparable. The daily risk of VAP was reduced in both treatment groups compared with PLAC: 65% (hazard ratio [HR]=0.352; 95% confidence interval [CI], 0.160, 0. 791; p=0.012) for CHX and 55% (HR=0.454; 95% CI, 0.224, 0. 925; p=0.030) for CHX/COL. CHX/COL provided significant reduction in oropharyngeal colonization with both gram-negative and gram-positive microorganisms, whereas CHX mostly affected gram-positive microorganisms. Endotracheal colonization was reduced for CHX/COL patients and to a lesser extent for CHX patients. No differences in duration of mechanical ventilation, intensive care unit stay, or intensive care unit survival could be demonstrated. CONCLUSIONS: Topical oral decontamination with CHX or CHX/COL reduces the incidence of VAP.

Feasibility and effects of the semirecumbent position to prevent ventilator-associated pneumonia: a randomized study.

CONTEXT: Reducing aspiration of gastric contents by placing mechanically ventilated patients in a semirecumbent position has been associated with lower incidences of ventilator-associated pneumonia (VAP). The feasibility and efficacy of this intervention in a larger patient population, however, are unknown. OBJECTIVE: Assessment of the feasibility of the semirecumbent position for intensive care unit patients and its influence on development of VAP. DESIGN: In a prospective multicentered trial, critically ill patients undergoing mechanical ventilation were randomly assigned to the semirecumbent position, with a target backrest elevation of 45 degrees , or standard care (i.e., supine position) with a backrest elevation of 10 degrees . MAIN OUTCOME MEASURES: Backrest elevation was measured continuously during the first week of ventilation with a monitor-linked device. A deviation of position was defined as a change of the randomized position >5 degrees . Diagnosis of VAP was made by quantitative cultures of samples obtained by bronchoscopic techniques. RESULTS: One hundred nine patients were assigned to the supine group and 112 to the semirecumbent group. Baseline characteristics were comparable for both groups. Average elevations were 9.8 degrees and 16.1 degrees at day 1 and day 7, respectively, for the supine group and 28.1 degrees and 22.6 degrees at day 1 and day 7, respectively, for the semirecumbent group (p < .001). The target semirecumbent position of 45 degrees was not achieved for 85% of the study time, and these patients more frequently changed position than supine-positioned patients. VAP was diagnosed in eight patients (6.5%) in the supine group and in 13 (10.7%) in the semirecumbent group (NS), after a mean of 6 (range, 3-9) and 7 (range, 3-12) days, respectively. There were no differences in numbers of patients undergoing enteral feeding, receiving stress ulcer prophylaxis, or developing pressure sores or in mortality rates or duration of ventilation and intensive care unit stay between the groups. CONCLUSIONS: The targeted backrest elevation of 45 degrees for semirecumbent positioning was not reached in the conditions of the present randomized study. The achieved difference in treatment position (28 degrees vs. 10 degrees ) did not prevent the development of VAP.

Clinical pulmonary infection score for ventilator-associated pneumonia: accuracy and inter-observer variability.

OBJECTIVE: Although quantitative microbiological cultures of samples obtained by bronchoscopy are considered the most specific tool for diagnosing ventilator-associated pneumonia, this labor-intensive invasive technique is not widely used. The Clinical Pulmonary Infection Score (CPIS), a diagnostic algorithm that relies on easily available clinical, radiographic, and microbiological criteria, could be an attractive alternative for diagnosing ventilator-associated pneumonia. Initially, the CPIS scoring system was validated upon 40 quantitative cultures of bronchoalveolar lavage fluid from 28 patients, and only few other studies have evaluated this scoring system since then. Therefore, little is known about the accuracy of this score. DESIGN: We compared the scores of a slightly adjusted CPIS with results from quantitative cultures of bronchoalveolar lavage fluid in 99 consecutive patients with suspicion of ventilator-associated pneumonia, using growth of > or =10(4) cfu/ml in bronchoalveolar lavage fluid as a cut-off for diagnosing ventilator-associated pneumonia. In addition, the CPIS were calculated for 52 patients by two different intensivists to determine the inter-observer variability. RESULTS: Ventilator-associated pneumonia was diagnosed in 69 (69.6%) patients. When using a CPIS >5 as diagnostic cutoff, the sensitivity of the score was 83% and its specificity was 17%. The area under the Receiver Operating Characteristic curve was 0.55. The level of agreement for prospectively measured Clinical Pulmonary Infection Score (< or =6 and >6) was poor (kappa =0.16). CONCLUSIONS: When compared to quantitative cultures of bronchoalveolar lavage fluid, the CPIS has a low sensitivity and specificity for diagnosing ventilator-associated pneumonia with considerable inter-observer variability.