Journal of the American College of Surgeons
-
Randomized Controlled Trial Comparative Study
Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.
Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. ⋯ Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial.
-
Randomized Controlled Trial Comparative Study
Pilot Randomized Controlled Trial of Laparoscopic Cholecystectomy vs Active Nonoperative Therapy for the Treatment of Biliary Dyskinesia.
Despite widespread adoption by the surgical community, high-quality prospective data supporting the practice of laparoscopic cholecystectomy (LC) for the treatment of biliary dyskinesia (BD) are lacking. ⋯ This pilot study raises doubts regarding the feasibility of a randomized trial, presumably due to both clinician and patient bias toward LC and the lack of "gold-standard" nonoperative treatments. However, these prospective data indicate that, with careful patient selection (standardized symptom criteria/imaging methodology), LC results in pain relief and significant improvement in QOL in BD patients. Further prospective study of these findings is warranted.
-
Randomized Controlled Trial Comparative Study
Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial.
Closed-suction drains, implants, and acellular dermal matrix (ADM) are routinely used in tissue expander-based immediate breast reconstruction (TE-IBR). Each of these factors is thought to increase the potential for surgical site infection (SSI). Although CDC guidelines recommend only 24 hours of antibiotic prophylaxis after TE-IBR, current clinical practices vary significantly. This study evaluated the difference in SSI between 2 different prophylactic antibiotic durations. ⋯ In a randomized controlled noninferiority trial, 24 hours of antibiotics is equivalent to extended oral antibiotics for SSI in TE-IBR patients. Additional multicenter trials will further assess this important aspect of TE-IBR postoperative care.
-
Randomized Controlled Trial
Composite Skin Grafting with Human Acellular Dermal Matrix Scaffold for Treatment of Diabetic Foot Ulcers: A Randomized Controlled Trial.
Composite split-thickness skin grafting (STSG) with acellular dermal matrix (ADM) has been used successfully in burn injuries and trauma, but its use in treating diabetic foot ulcers (DFUs) has not been reported to date. This study investigated the efficacy and safety of composite STSG with ADM in the treatment of DFUs. ⋯ Composite STSG over an ADM scaffold provides an effective method to treat DFUs, with lower recurrence rates and better physical attributes compared with the traditional STSG method. Complete wound closure and complication rates were comparable between these methods.
-
Randomized Controlled Trial Comparative Study Pragmatic Clinical Trial
Program Director Perceptions of Surgical Resident Training and Patient Care under Flexible Duty Hour Requirements.
The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial was a national, cluster-randomized, pragmatic, noninferiority trial of 117 general surgery programs, comparing standard ACGME resident duty hour requirements ("Standard Policy") to flexible, less-restrictive policies ("Flexible Policy"). Participating program directors (PDs) were surveyed to assess their perceptions of patient care, resident education, and resident well-being during the study period. ⋯ Program directors involved in the FIRST trial perceived improvements in patient safety, continuity of care, and multiple aspects of resident education and well-being with flexible duty hours.