scholarly journals Reduction of Perioperative Antibiotic Prophylaxis in Open Radical Cystectomy with Ileal Conduit Is Feasible: Results of a Prospective Clinical Trial

2021 ◽  
pp. 1-7
Author(s):  
Laila Schneidewind ◽  
Laura Torabi ◽  
Desiree L. Dräger ◽  
Oliver W. Hakenberg
Keyword(s):  
Clinical Trial ◽  
Antibiotic Prophylaxis ◽  
Radical Cystectomy ◽  
Ileal Conduit ◽  
Prospective Clinical Trial ◽  
Ethical Review ◽  
Fisher Exact Test ◽  
Antibiotic Administration ◽  
Single Shot ◽  
Tract Infections

<b><i>Introduction:</i></b> The aim of this study is to perform a prospective clinical trial in antibiotic prophylaxis, infectious complication, and colonization of ileal conduit (IC) following radical cystectomy (RC) since urinary tract infections (UTIs) and surgical site infections (SSIs) contribute significantly to the morbidity associated with RC and IC. Moreover, an optimal regimen of antibiotic prophylaxis has not been established, yet. <b><i>Material and Methods:</i></b> After a positive vote of ethical review committee and the registration at the German Clinical Trials Register (DKRS 00020406), we started a prospective clinical unicentric not interventional study. The urine samples were collected by sterile catheterization of the IC. All patients received an antibiotic prophylaxis with 3 × 500 mg metronidazole and 3 × 1.5 g cefuroxime intravenously for 3 days starting on the day before RC. Ureteral stents got removed on days 9 and 10 after surgery without prior antibiotic administration. The student <i>t</i> test and the χ<sup>2</sup> test or the Fisher exact test were used. For risk factor assessment, the univariate Cox regression method was applied. <b><i>Results:</i></b> Nineteen male (63.3%) and 11 female patients (36.7%) with a median age of 70.5 years were included. Three patients developed complicated UTI (10%) on day 12 after RC with <i>E. faecium</i> and needed antibiotic treatment with meropenem (Clavien-Dindo II). Two patients (6.7%) developed SSI with <i>E. faecium</i> and needed surgery (Clavien-Dindo IIIb). Palliative RC (<i>p</i> &#x3c; 0.0001), prior radiation therapy (<i>p</i> &#x3c; 0.0001), and timeframe &#x3e;3 months from diagnosis to RC (<i>p</i> = 0.036) are significantly associated with the development of complicated UTI. Interestingly, the IC got colonized with Staph. haemolyticus at day 12 after RC (<i>n</i> = 12; 40.0%). We must assume that our data have some limitations like a unicentric study population. <b><i>Conclusion:</i></b> Further evaluation of reduction to single-shot antibiotic prophylaxis in nonpalliative RC with IC could be feasible.

Single-shot celiac plexus radiosurgery in pancreatic cancer: Palliative and functional outcomes—Final results of a prospective clinical trial.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 309-309
Author(s):  
Yaacov Richard Lawrence ◽  
Einat Shacham Shmueli ◽  
Liat Hammer ◽  
Ofir Morag ◽  
Maoz Ben-Ayun ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Cancer Patients ◽  
Post Treatment ◽  
Celiac Plexus ◽  
Pain Interference ◽  
Prospective Clinical Trial ◽  
Single Shot ◽  
Single Fraction ◽  
Median Baseline

309 Background: Pancreatic cancer is characterized by severe epigastric/lower back pain caused by infiltration of the celiac plexus. The celiac plexus is a network of nociceptive nerves, located along the abdominal aorta. Contemporary approaches (opioids, celiac plexus chemical neurolysis, systemic chemotherapy) are often inadequate. We hypothesized that ablative radiation targeted to the celiac plexus would alleviate pain. Here we report results for pancreatic cancer patients treated with a single fraction of radiation. Methods: We conducted a single-institution single-arm prospective clinical trial. Eligible cancer patients had celiac-pain > 4/10 on Numerical Rating Scale (NRS) and completed treatment per protocol with at least one post-treatment visit. The celiac plexus was irradiated from D12 to L2. Radiation was given as a single-fraction 25 Gy. The primary endpoint was NRS pain 3 weeks post-treatment. Secondary endpoints were toxicity, pain at 6w, analgesic use, and pain interference with daily activities as evaluated by the ‘The Brief Pain Inventory’. Analgesia was not restricted. Total daily dose of opioids was measured in morphine milligram equivalents (MME). Results: Seventeen patients were evaluable, 65% female, median age 68 yr (range 51-79), three had undergone pancreatic resection, nine had liver metastases, median ECOG = 1. Sixteen patients reported 3-week outcomes, and 10 reported 6-week outcomes. At time of treatment subjects were a median of 8.2 months from diagnosis, and had received a median of one systemic treatment (range 0-3). Toxicity was limited to grade 1. Median baseline pain was 6/10 (IQR 5-7), was reduced to 2.3/10 (IQR 0.9-3.6) (p < 0.0005) at 3 w, and to 2.5/10 (IQR 0-3.1) at 6 w post-treatment, for both p < 0.001. Median opioid consumption numerically decreased (baseline 52.9 MME, 3 w 43.9 MME, 6 w 37.5 MME, NS). ‘BPI pain interference’ improved significantly: median baseline score 7.1 dropped to 1.1 at 3 weeks and 0 at 6 weeks (p < 0.01 for both time points). Conclusions: Celiac plexus radiosurgery alleviates pain, and improves quality of life among patients with pancreatic cancer. A follow-up international trial is accruing. Clinical trial information: NCT02356406.

scholarly journals Protocol for Antibiotic Administration in Mandibular Trauma: A Prospective Clinical Trial

2016 ◽  
Vol 17 (1) ◽  
pp. 19-23 ◽  
Author(s):  
Anisha Perepa ◽  
Ramen Sinha ◽  
Anmol Agarwal ◽  
Tahseen Ali Khan
Keyword(s):  
Clinical Trial ◽  
Prospective Clinical Trial ◽  
Antibiotic Administration

scholarly journals A Pilot Randomised Clinical Trial Comparing a Short-Term Perioperative Prophylaxis Regimen to a Long-Term Standard Protocol in Equine Colic Surgery

Antibiotics ◽  
2021 ◽  
Vol 10 (5) ◽  
pp. 587
Author(s):  
Sabita Diana Stöckle ◽  
Dania A. Kannapin ◽  
Anne M. L. Kauter ◽  
Antina Lübke-Becker ◽  
Birgit Walther ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Antibiotic Prophylaxis ◽  
Haemolytic Anaemia ◽  
Surgical Site Infections ◽  
Single Shot ◽  
Short Term ◽  
Current Standard ◽  
Surgical Interventions ◽  
Amyloid A ◽  
Equine Colic

Background: For surgical interventions classified as clean or clean-contaminated, including laparotomy, guidelines in human and veterinary medicine recommend a short-term perioperative antibiotic prophylaxis (PAP). In equine colic surgery, however, PAP commonly exceeds 24 h. Objectives: The aim of this study was to compare a single-shot to a 5-day lasting PAP considering surgical site infections (SSI) and other adverse effects probably associated with the particular antimicrobial regimen. Study design: The study was designed as a randomised non-inferiority pilot study including horses subjected to colic surgery while receiving one of two distinct PAP regimens. Methods: All horses (n = 67) included in the study received the standard physical examination before and after surgery. Colic surgery was performed according to the current standard of the clinic. Horses were randomly assigned to two groups, receiving either the “single-shot” or the “5-day lasting” antibiotic prophylaxis. The “single-shot” group (n = 30) received penicillin and gentamicin only once before and, if needed, during surgery, whereas the “5-day lasting” group (n = 37) received antibiotics for five days. In addition to the standard laboratory examinations, serum amyloid A and fibrinogen were determined preoperatively and during five days after surgery. SSI, postoperative colitis and haemolytic anaemia were classified as postoperative complications potentially related to antibiotic use. Results: The outcome of this preliminary non-inferiority clinical trial showed that the occurrence of postoperative adverse events (i.e., SSI, postoperative colitis and haemolytic anaemia) lacked significant differences between the study groups. Main limitations: The main limitations of this study are the limited group sizes and our inability to blind the study. Conclusions: Single-shot PAP seems to be an alternative approach considering the 5-day lasting protocol commonly used in equine abdominal surgery. However, a proper hygiene management together with a close clinical and laboratory monitoring of the equine patient is indispensable.

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