RCT

BACKGROUND: Staple fixation of mesh during laparoscopic total extraperitoneal (TEP) inguinal repair is thought to be necessary to prevent recurrence. However, mesh fixation may increase surgical complications and pain. Therefore, a meta-analysis of randomized controlled trials (RCTs) was conducted to compare the outcomes of nonfixation with fixation of mesh by metal tacks during TEP inguinal hernia repair. METHODS: The meta-analysis was conducted according to the Quality of Reporting of Meta-analyses (QUOROM) standards...

BACKGROUND: Groin hernia repair is one of the commonest operations in general surgery. Existing techniques have very low and acceptable recurrence rates, but chronic pain and discomfort remain a problem for many patients. New mesh materials are being developed to increase biocompatibility, and the aim of this study was to compare a new titanium-coated lightweight mesh with a standard polypropylene mesh. METHODS: A randomized controlled single-centre clinical trial was designed, with the basic principle of one unit, one surgeon, one technique (Lichtenstein under general anaesthesia) and two meshes...

OBJECTIVE: Pancreatic fistula (PF) is a leading cause of morbidity and mortality after pancreaticoduodenectomy (PD). The aim of this multicenter prospective randomized trial was to compare the results of PD with an external drainage stent versus no stent. METHODS: Between 2006 and 2009, 158 patients who underwent PD were randomized intraoperatively to either receive an external stent inserted across the anastomosis to drain the pancreatic duct (n = 77) or no stent (n = 81)...

BACKGROUND: In recent years, use of prosthetic material for inguinal hernia repair has increased dramatically. Tension-free repairs have gained popularity not only for recurrent or complicated hernias, but for primary hernia repairs as well. Although routine use of prophylactic antibiotics is not recommended in the Philippines for open nonimplant herniorrhaphy, there is little direct clinical evidence on which to base recommendations when implantable mesh is used. STUDY DESIGN: We conducted a prospective, randomized, double-blind, placebo-controlled trial comparing wound infection rates in 360 patients (180 received prophylactic antibiotics, 180 received a placebo) undergoing primary inguinal hernia repair electively using polypropylene mesh...

BACKGROUND: Advanced gastric cancer in the upper or middle third of the stomach is routinely treated with a total gastrectomy, albeit in some cases with higher morbidity and mortality. The aim of this study was to describe the morbimortality and survival results in total gastrectomy in a single center. METHODS: This retrospective study included patients with gastric adenocarcinoma treated with a total gastrectomy at a single Brazilian cancer center between January 1988 and December 2011...

BACKGROUND: Recent data have suggested a relationship between postoperative fatigue and the peritoneal cytokine response after surgery. The aim of this study was to test the hypothesis that preoperative administration of glucocorticoids before surgery would decrease fatigue and enhance recovery, by reducing the peritoneal production of cytokines. METHODS: In a double-blind randomized controlled study, patients undergoing elective, open colonic resection were administered 8 mg dexamethasone or normal saline...

IMPORTANCE: Ninety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment. OBJECTIVE: To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy. DESIGN, SETTING, AND PATIENTS: A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012...

BACKGROUND: Pancreatic fistula remains the primary source of morbidity following distal pancreatectomy. Previous studies have reported specific methods of parenchymal transection/stump sealing in an effort to decrease the pancreatic fistula rate with highly variable results. The aim of this study was to determine postoperative outcomes following various pancreatic stump-sealing methods. STUDY DESIGN: All cases of distal pancreatectomy were reviewed at a single institution between January 2008 and June 2011 and were monitored with complete 30-day outcomes through ACS-NSQIP...

OBJECTIVE: Laparoscopic paraesophageal hernia repair (LPEHR) is associated with a high recurrence rate. Repair with synthetic mesh lowers recurrence but can cause dysphagia and visceral erosions. This trial was designed to study the value of a biologic prosthesis, small intestinal submucosa (SIS), in LPEHR. METHODS: Patients undergoing LPEHR (n = 108) at 4 institutions were randomized to primary repair -1 degrees (n = 57) or primary repair buttressed with SIS (n = 51) using a standardized technique...

BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin...

BACKGROUND: Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS: We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year...

BACKGROUND: Controversy exists about the timing of the initiation of parenteral nutrition in critically ill adults in whom caloric targets cannot be met by enteral nutrition alone. METHODS: In this randomized, multicenter trial, we compared early initiation of parenteral nutrition (European guidelines) with late initiation (American and Canadian guidelines) in adults in the intensive care unit (ICU) to supplement insufficient enteral nutrition. In 2312 patients, parenteral nutrition was initiated within 48 hours after ICU admission (early-initiation group), whereas in 2328 patients, parenteral nutrition was not initiated before day 8 (late-initiation group)...

OBJECTIVE: We investigate the neutrophil to lymphocyte ratio (NLR) as a potential prognostic factor for patients undergoing curative liver resection for colorectal liver metastasis (CRLM). METHODS: We identified patients who underwent liver resection, via our prospectively accumulated surgical database at the Royal Marsden Hospital and The London Clinic, by two liver surgeons (SM and AZK) between January 2005 and December 2012 and patients included had liver resection for CRLM and received preoperative chemotherapy with an NLR > 2...

BACKGROUND: Temporary faecal diversion is recommended with a low colorectal, coloanal or ileoanal anastomosis (LA). This randomized study evaluated early (EC; 8 days) versus late (LC; 2 months) closure of the temporary stoma. METHODS: Patients undergoing rectal resection with LA were eligible to participate. If there was no radiological sign of anastomotic leakage after 7 days, patients were randomized to EC or LC. The primary endpoints were postoperative morbidity and mortality 90 days after the initial resection...

BACKGROUND AND OBJECTIVES: Only limited data exist investigating the outcome of patients older than 75 years after resection of colorectal liver metastases (CLM). Therefore, the present study aims to evaluate clinical and oncological outcome of elderly patients. METHODS: A cohort of 405 patients was divided into three age-groups: (1) <65 years; (2) 65-75 years; and (3) >75 years of age. Patients' data were prospectively collected and retrospectively analyzed...

Optimal perioperative fluid administration in major gastrointestinal surgery remains a challenging clinical problem. Traditional dogma of a liberal approach to fluid administration in order to counteract potential hypovolemia and decreased end-organ perfusion can often result in fluid overload, perhaps negatively impacting perioperative outcomes. This hypothesis has been investigated in several types of gastrointestinal surgery. We discuss the current literature on perioperative fluid administration in colorectal and pancreatic surgery and highlight the controversies that still exist...

BACKGROUND: Postoperative pancreatic fistula is a major contributor to complications and death associated with pancreatic resection. Pasireotide, a somatostatin analogue that has a longer half-life than octreotide and a broader binding profile, decreases pancreatic exocrine secretions and may prevent postoperative pancreatic fistula. METHODS: We conducted a single-center, randomized, double-blind trial of perioperative subcutaneous pasireotide in patients undergoing either pancreaticoduodenectomy or distal pancreatectomy...

OBJECTIVE: The objective of this study was to investigate the effects of 2 levels of intraoperative fluid administration on perioperative physiology and outcome after laparoscopic cholecystectomy. SUMMARY BACKGROUND DATA: Intraoperative fluid administration is variable as a result of limited knowledge of physiological and clinical effects of different fluid substitution regimens. METHODS: In a double-blind study, 48 ASA I-II patients undergoing laparoscopic cholecystectomy were randomized to 15 mL/kg (group 1) or 40 mL/kg (group 2) intraoperative administration of lactated Ringer's solution (LR)...

OBJECTIVE: To determine the clinical safety and efficacy of preoperative glucocorticoid (GC) administration in major abdominal surgery with regards to short term outcomes. BACKGROUND: Previous randomized controlled trials (RCTs) in major abdominal surgery have displayed conflicting results regarding the short-term benefits of preoperative GC administration. Importantly, the safety of this intervention has not been conclusively determined. METHODS: A systematic review and quantitative meta-analysis was conducted of all RCTs exploring preoperative GC administration in major abdominal surgery for the endpoints of complications, hospital length of stay (LOS) and serum IL-6 on postoperative day one...

IMPORTANCE: The optimal management of treatment for patients at intermediate risk of a common duct stone (including increased liver function tests but bilirubin <4 mg/dL and no cholangitis) is a matter of debate. Many stones migrate spontaneously into the duodenum, making preoperative common duct investigations unnecessary. OBJECTIVE: To compare strategies of cholecystectomy first vs a sequential endoscopic common duct assessment and cholecystectomy for the management of patients with an intermediate risk of a common duct stone...