ABSTRACT
This study protocol for a prospective, multicenter, diagnostic, clinical trial describes the integration of transoral and transcervical ultrasonography (US) in the initial clinical work-up of patients referred to tertiary head and neck cancer centers with suspected oropharyngeal cancer. The study evaluates the blinded detection rate of oropharyngeal tumors and their US-estimated size and T-stage before histopathology and cross-sectional imaging are available. Magnetic resonance imaging (MRI) scans will be prospectively rated while blinded to T-site histopathology and US. The primary outcome measures of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values, and overall accuracy, will be reported for both US and MRI. A sub-analysis of prospectively rated 18F-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography (PET/CT) scans in patients with clinically suspected unknown primary tumors will also be compared to US and MRI. Secondary outcome measures, including a comparison of tumor size estimation between US, MRI, and CT, will also be reported. This prospective multicenter study will provide clinically impactful information regarding the use of transoral and transcervical US for the diagnostic work-up of oropharyngeal cancer.
ABSTRACT
INTRODUCTION: Laparoscopic colectomy for both benign and malignant disease, including inflammatory bowel disease (IBD), has recently been shown to have many advantages compared with open surgery. This study aimed to compare the effect of laparoscopic versus open subtotal colectomy (STC) for IBD on overall morbidity. MATERIAL AND METHODS: A total of 99 patients undergoing STC for IBD at our institution from 2007 through 2011 were identified. Patients undergoing open STC were compared with patients undergoing laparoscopic STC. Outcomes included 30-day morbidity, conversion to laparotomy, intraoperative blood loss, operative time, admission time, late onset complications and 30-day mortality. Results are presented as median values. RESULTS: A total of 57 patients underwent open STC (Group 1) and 42 patients laparoscopic STC (Group 2). Group 1 comprised 26 males and 31 females, with a median age of 35 years and a body mass index (BMI) of 23.2 kg/m2. Group 2 comprised 18 males and 24 females, with a median age of 34 years and a BMI of 23.5 kg/m2. Group 2 had less morbidity (42.9% versus 75.4%, p < 0.002), reduced blood loss (100 ml versus 200 ml, p < 0.001), longer operative time (193.5 min. versus 128 min., p < 0.001), shorter length of hospital stay (six days versus 16 days, p < 0.001) than Group 1. One patient died (Group 1). There was no difference in late onset complications and no conversions to laparotomy in the laparoscopic group. CONCLUSION: Laparoscopic STC has a longer operative time, but improves short-term outcomes compared with open surgery. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.
