Oral antibiotic bowel decontamination in open and laparoscopic sigmoid resections for diverticular disease.

PURPOSE: There is an ongoing debate on whether or not to use oral antibiotic bowel decontamination in colorectal surgery, despite the numerous different regimens in terms of antibiotic substances and duration of application. As we routinely use oral antibiotic bowel decontamination (selective decontamination of the digestive tract (SDD) regimen and SDD regimen plus vancomycin since 2016) in surgery for diverticular disease, our aim was to retrospectively analyze the perioperative outcome in two independent centers. METHODS: Data from two centers with a routine use of oral antibiotic bowel decontamination for up to 20 years of experience were analyzed for the perioperative outcome of 384 patients undergoing surgery for diverticular disease. RESULTS: Overall morbidity was 12.8%, overall mortality was 0.3%, the overall rate of anastomotic leakage (AL) was 1.0%, and surgical site infections (SSIs) were 5.5% and 7.8% of all infectious complications including urinary tract infections and pneumonia. No serious adverse events were related to use of oral antibiotic bowel decontamination. Most of the patients (93.8%) completed the perioperative regimen. Additional use of vancomycin to the SDD regimen did not show a further reduction of infectious complications, including SSI and AL. CONCLUSION: Oral antibiotic decontamination appears to be safe and effective with low rates of AL and infectious complications in surgery for diverticular disease.

Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer.

BACKGROUND: The implementation of quality of life (QoL) concepts in routine care, is still an open matter. We followed the Medical Research Council framework for complex interventions to implement a model of QoL diagnosis and therapeutic options, and investigated its effectiveness in patients with colorectal cancer. METHODS: This randomised, single-blind, multicentre, clinical trial enrolled patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany. All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies. QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months). Patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control). The primary endpoint was the proportion of patients in each group with a need for QoL therapy 12 months after surgery. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02321813 and closed to accrual. FINDINGS: Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n = 110 per group). At baseline (in hospital after surgery), a need for QoL therapy was diagnosed in 92/103 (89%) of intervention and 86/104 (83%) of control group patients. At 12 months (primary endpoint) the proportion of patients with a need for QoL therapy was 35/83 (42%; 95% CI 31-54%) in the intervention group versus 50/87 (57%; 95% CI: 46-68%) in the control group (p = 0·046, number needed to treat = 7; 95% CI 3-225). INTERPRETATION: Patients profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment of colorectal cancer. This trial confirmed the results of a previous RCT in breast cancer patients. The implementation of QoL concepts should become standard in treatment guidelines on cancer care. FUNDING: Federal Ministry of Education and Research (BMBF; grant no. 01GY1339). CLINICAL TRIAL INFORMATION: NCT02321813.

The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction - a phase III trial of the German AIO/CAO-V/CAOGI.

BACKGROUND: Historical data indicate that surgical resection may benefit select patients with metastatic gastric and gastroesophageal junction cancer. However, randomized clinical trials are lacking. The current RENAISSANCE trial addresses the potential benefits of surgical intervention in gastric and gastroesophageal junction cancer with limited metastases. METHODS: This is a prospective, multicenter, randomized, investigator-initiated phase III trial. Previously untreated patients with limited metastatic stage (retroperitoneal lymph node metastases only or a maximum of one incurable organ site that is potentially resectable or locally controllable with or without retroperitoneal lymph nodes) receive 4 cycles of FLOT chemotherapy alone or with trastuzumab if Her2+. Patients without disease progression after 4 cycles are randomized 1:1 to receive additional chemotherapy cycles or surgical resection of primary and metastases followed by subsequent chemotherapy. 271 patients are to be allocated to the trial, of which at least 176 patients will proceed to randomization. The primary endpoint is overall survival; main secondary endpoints are quality of life assessed by EORTC-QLQ-C30 questionnaire, progression free survival and surgical morbidity and mortality. Recruitment has already started; currently (Feb 2017) 22 patients have been enrolled. DISCUSSION: If the RENAISSANCE concept proves to be effective, this could potentially lead to a new standard of therapy. On the contrary, if the outcome is negative, patients with gastric or GEJ cancer and metastases will no longer be considered candidates for surgical intervention. TRIAL REGISTRATION: The article reports of a health care intervention on human participants and is registered on October 12, 2015 under ClinicalTrials.gov Identifier: NCT02578368 ; EudraCT: 2014-002665-30.

Spotlight on esophageal perforation: A multinational study using the Pittsburgh esophageal perforation severity scoring system.

OBJECTIVE: The Pittsburgh group has suggested a perforation severity score (PSS) for better decision making in the management of esophageal perforation. Our study aim was to determine whether the PSS can be used to stratify patients with esophageal perforation into distinct subgroups with differential outcomes in an independent study population. METHODS: In a retrospective study cases of esophageal perforation were collected (study-period, 1990-2014). The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate, and high score groups. RESULTS: Data for 288 patients (mean age, 59.9 years) presenting with esophageal perforation (during the period 1990-2014) were abstracted. Etiology was spontaneous (Boerhaave; n = 119), iatrogenic (instrumentation; n = 85), and traumatic perforation (n = 84). Forty-three patients had coexisting esophageal cancer. The mean PSS was 5.82, and was significantly higher in patients with fatal outcome (n = 57; 19.8%; mean PSS, 9.79 vs 4.84; P < .001). Mean PSS was also significantly higher in patients receiving operative management (n = 200; 69%; mean PSS, 6.44 vs 4.40; P < .001). Using the Pittsburgh strata, patients were assigned to low PSS (≤2; n = 63), intermediate PSS (3-5; n = 86), and high PSS (>5; n = 120) groups. Perforation-related morbidity, length of stay, frequency of operative treatment, and mortality increased with increasing PSS strata. Patients with high PSS were 3.37 times more likely to have operative management compared with low PSS. CONCLUSIONS: The Pittsburgh PSS reliably reflects the seriousness of esophageal perforation and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes.