Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device.

BACKGROUND AND OBJECTIVE: The Harmonic ACE+7 Shears with Advanced Hemostasis Mode (Ethicon, Somerville, NJ, USA) is an ultrasonic device designed to transect and seal vessels up to 7 mm in diameter. The device applies an algorithm that optimizes ultrasonic energy delivery combined with a longer sealing cycle. The purpose of this study was to assess the initial clinical experience with the Harmonic device by evaluating large-vessel sealing during laparoscopic colectomy in consecutive cases. METHODS: This prospective, multicenter, observational series involved 40 adult patients who were to undergo elective laparoscopic colectomy where dissection and transection of the inferior mesenteric artery was indicated. The primary study endpoint was first-pass hemostasis, defined as a single activation of the Advanced Hemostasis Mode to transect and seal the inferior mesenteric artery. The use of any additional energy device or hemostatic product to establish or maintain hemostasis was noted. Patients were observed after surgery for ∼4 weeks for adverse events that were considered to be related to the study procedure or study device. Descriptive statistical analyses were performed for study endpoints. RESULTS: Forty patients underwent the laparoscopic colectomy procedure. First-pass hemostasis of the inferior mesenteric artery was achieved and maintained in all 40 patients, with no required additional hemostatic measures. Exposure of the vessel was reported as skeletonized in 22 of 40 (55%) patients. Mean transection time was 21.9 ± 7.4 s. One adverse event (postoperative anemia) was considered possibly related to the study device. CONCLUSION: In this initial clinical consecutive series, the device demonstrated successful transection and sealing of the large mesenteric vessels during laparoscopic colorectal surgery.

Source control review in clinical trials of anti-infective agents in complicated intra-abdominal infections.

In clinical trials of complicated intra-abdominal infections, assessment of adequacy of the initial surgical approach to the management of the infection is of considerable importance in determining outcome. Antibiotic therapy would not be expected to adequately treat the infection if the surgical procedure was inadequate with respect to source control. Inclusion of such cases in an efficacy analysis of a particular therapeutic antibiotic may confound the results. We analyzed the source control review process used in double-blind clinical trials of antibiotics in complicated intra-abdominal infections identified through systematic review. We searched MEDLINE (PubMed) and ClinicalTrials.gov databases to identify relevant articles reporting results from double-blind clinical trials that used a source control review process. Eight prospective, randomized, double-blind, multicenter, clinical trials of 5 anti-infective agents in complicated intra-abdominal infections used a source control review process. We provide recommendations for an independent, adjudicated source control review process applicable to future clinical trials.