Annals of surgery
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Randomized Controlled Trial Multicenter Study
Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials.
The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts. ⋯ 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.
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Randomized Controlled Trial
A Randomized Controlled Trial Examining the Impact of an Anorectal Surgery Multimodal Enhanced Recovery Program on Opioid Use.
Anorectal cases may be a common gateway to the opioid epidemic. Opioid reduction is inherent in enhanced recovery after surgery (ERAS) protocols, but little work has evaluated ERAS in these cases. ⋯ An ERAS protocol in ambulatory anorectal surgery is feasible, and resulted in reduced opioid use, and healthcare utilization, with no difference in pain or patient satisfaction. This challenges the paradigm that extended opioids are needed for effective postoperative pain management.
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Randomized Controlled Trial Multicenter Study
A Phase 3 Randomized Clinical Trial of Chemotherapy With or Without Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy in Subjects with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer.
To compare the efficacy and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). ⋯ Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.
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Randomized Controlled Trial
Randomized Trial of Laparoscopic Nissen vs. Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15-20 years.
To determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication. ⋯ At 15 to 20 years follow-up Nissen and anterior 180-degree partial fundoplication achieved similar success, but with trade-offs between better reflux control versus more side-effects after Nissen fundoplication.
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Randomized Controlled Trial Multicenter Study
Influence of the Retrocolic Versus Antecolic Route for Alimentary Tract Reconstruction on Delayed Gastric Emptying After Pancreatoduodenectomy: A Multicenter, Noninferiority Randomized Controlled Trial.
This study aimed to determine whether retrocolic alimentary tract reconstruction is noninferior to antecolic reconstruction in terms of DGE incidence after pancreatoduodenectomy (PD) and investigated patients' postoperative nutritional status. ⋯ This trial could not demonstrate the noninferiority of retrocolic to antecolic alimentary tract reconstruction in terms of DGE incidence. The alimentary tract should not be reconstructed via the retrocolic route after PD, to prevent DGE.