Annals of surgery
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Randomized Controlled Trial
No Clinical Benefit of Intramuscular Delivery of Bone Marrow-derived Mononuclear Cells in Nonreconstructable Peripheral Arterial Disease: Results of a Phase-III Randomized-controlled Trial.
Prospects for no-option, end-stage peripheral artery disease (PAD) patients remain poor. Although results from open and semiblinded studies fuel hope for cell-based strategies in no-option patients, so far conclusions from the available placebo-controlled studies are not supportive. With the intention to end the remaining controversy with regard to cell therapy for PAD we conducted a confirmatory, double-blinded randomized placebo-controlled phase 3 trial. ⋯ This fully blinded replication trial of autologous BM-MNC fails to confirm a benefit for cell therapy in no-option PAD patients, consequently BM-MNC therapy should not be offered as a clinical treatment. Apparent contrasting conclusions from open and controlled studies underscore the importance of a controlled trial design in evaluating cell-based interventions in PAD.
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Randomized Controlled Trial
Quadratus Lumborum Block Versus Perioperative Intravenous Lidocaine for Postoperative Pain Control in Patients Undergoing Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-blind Controlled Clinical Trial.
To investigate the comparative analgesic efficacy of systemic lidocaine and quadratus lumborum (QL) block in laparoscopic colorectal surgery. ⋯ In our trial, the QL-block did not provide superior postoperative analgesia when compared to systemic lidocaine in laparoscopic colorectal surgery.
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Randomized Controlled Trial Comparative Study
Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial.
To compare perioperative outcomes of pancreatoduodenectomy (PD) performed through the laparoscopic route or by open surgery. ⋯ Laparoscopic PD versus open surgery is associated with a shorter LOS and a more favorable postoperative course while maintaining oncological standards of a curative-intent surgical resection.
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Randomized Controlled Trial Comparative Study
Cost-effectiveness of Randomized Study of Laparoscopic Versus Open Bilateral Inguinal Hernia Repair.
The aim of this study is to compare the clinical and cost-effective outcomes of the open Lichtenstein repair (OL) and laparoscopic trans-abdominal preperitoneal (TAPP) repair for bilateral inguinal hernias. ⋯ The TAPP procedure for bilateral inguinal hernia appears to be more cost-effective compared with OL.
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Randomized Controlled Trial
Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial.
The aim of this study was to determine whether preoperative nutritional counseling and exercise (prehabilitation) in obese patients with ventral hernia repair (VHR) results in more hernia-free and complication-free patients. ⋯ This trial was registered with clinicaltrials.gov (NCT02365194).