Journal of the American College of Surgeons
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Randomized Controlled Trial Multicenter Study Comparative Study
A Multicenter Randomized Trial to Evaluate Hematologic Toxicities after Hyperthermic Intraperitoneal Chemotherapy with Oxaliplatin or Mitomycin in Patients with Appendiceal Tumors.
Appendiceal cancer is a rare disease that has proven difficult to study in prospective trials. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is an established therapy for peritoneal dissemination from appendiceal cancer. The optimal chemotherapeutic agent to use in the HIPEC is not clear. Mitomycin has long been used, however, our previous phase I experience and European retrospective studies suggest oxaliplatin as an alternative. Therefore, we initiated a multicenter randomized trial to compare mitomycin with oxaliplatin HIPEC for appendiceal cancer. ⋯ This represents the first completed prospective randomized trial for cancer of the appendix, and shows that multicenter trials for this disease are feasible. Both mitomycin and oxaliplatin are associated with minor hematologic toxicity. However, mitomycin has slightly higher hematologic toxicity and lower quality of life than oxaliplatin in HIPEC. Consequently, oxaliplatin might be preferred in patients with leukopenia and mitomycin preferred in patients with thrombocytopenia due to earlier chemotherapy.
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Randomized Controlled Trial
A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options.
Previous research suggests that providing information to women newly diagnosed with breast cancer, during the gap between cancer diagnosis and their first surgeon consultation, may support decision making. Our objective was to compare patients' knowledge after the pre-consultation delivery of standard websites vs a web-based decision aid (DA). ⋯ Although patients found receipt of any pre-consultation information helpful, the DA resulted in improved knowledge over standard websites and effectively conveyed that there is time to make a breast cancer surgery decision. Decreasing the urgency patients feel may improve the quality of patient-surgeon interactions and lead to more informed decision-making.
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Randomized Controlled Trial Multicenter Study Comparative Study
Hartmann's Procedure or Primary Anastomosis for Generalized Peritonitis due to Perforated Diverticulitis: A Prospective Multicenter Randomized Trial (DIVERTI).
About 25% of patients with acute diverticulitis require emergency intervention. Currently, most patients with diverticular peritonitis undergo a Hartmann's procedure. Our objective was to assess whether primary anastomosis (PA) with a diverting stoma results in lower mortality rates than Hartmann's procedure (HP) in patients with diverticular peritonitis. ⋯ Although mortality was similar in both arms, the rate of stoma reversal was significantly higher in the PA arm. This trial provides additional evidence in favor of PA with diverting ileostomy over HP in patients with diverticular peritonitis. ClinicalTrials.gov Identifier: NCT 00692393.
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Randomized Controlled Trial
Randomized Clinical Trial of Epidural Compared to Conventional Analgesia after Minimally Invasive Colorectal Surgery.
The effectiveness of thoracic epidural analgesia (EA) vs conventional IV analgesia (IA) after minimally invasive surgery is still unproven. We designed a randomized controlled trial comparing EA with IA after minimally invasive colorectal surgery. ⋯ This study indicates that EA has no added clinical benefit in patients undergoing minimally invasive colorectal surgery. A trend toward higher total narcotics use and complications with EA was demonstrated.
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Randomized Controlled Trial Comparative Study
Comparison of Analgesic Efficacy of Laparoscope-Assisted and Ultrasound-Guided Transversus Abdominis Plane Block after Laparoscopic Colorectal Surgery: A Randomized, Single-Blind, Non-Inferiority Trial.
Transversus abdominis plane (TAP) block has been used as a component of multimodal analgesia after abdominal operation. We introduced a new laparoscope-assisted TAP (LTAP) block technique using intraperitoneal injection and compared its analgesic effect with that of an ultrasound-guided TAP (UTAP) block in terms of postoperative pain control. ⋯ These results show our new LTAP block technique was non-inferior to the ultrasound-guided technique in providing a TAP block after laparoscopic colorectal operation.