The British journal of surgery
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Randomized Controlled Trial Multicenter Study Comparative Study
Outcomes of laparoscopic gastric bypass in a randomized clinical trial compared with a concurrent national database.
RCTs are the standard for assessing medical interventions, but they may not be feasible and their external validity is sometimes questioned. This study aimed to compare results from an RCT on mesenteric defect closure during laparoscopic gastric bypass with those from a national database containing data on the same procedure, to shed light on the external validity of the RCT. ⋯ The efficacy of mesenteric defect closure was similar in the RCT and national registry, providing evidence for the external validity of the RCT.
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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study).
Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter hospital stay and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided. ⋯ This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual. Registration number: NCT00874224 ( https://www.clinicaltrials.gov).
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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized clinical trial comparing standard diet with perioperative oral immunonutrition in total gastrectomy for gastric cancer.
Total gastrectomy for gastric cancer is associated with excessive weight loss and decreased calorie intake. Nutritional support using eicosapentaenoic acid modulates immune function and limits catabolism in patients with advanced cancer, but its impact in the perioperative period is unclear. ⋯ Immunonutrition based on an eicosapentaenoic acid-enriched oral diet did not reduce bodyweight loss after total gastrectomy for gastric cancer compared with a standard diet. Registration number: UMIN000006380 ( http://www.umin.ac.jp/).
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Randomized Controlled Trial Multicenter Study
Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis.
Few studies have investigated the effects of preoperative dexamethasone in acute surgical patients. This study examined the effects of 8 mg dexamethasone administered intravenously 30 min before surgery for suspected acute appendicitis. ⋯ Preoperative dexamethasone did not reduce PONV by the target level of 50 per cent. Registration number: NCT02415335 ( http://www.clinicaltrials.gov).
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Randomized Controlled Trial Multicenter Study
Randomized clinical trial of sacral nerve stimulation for refractory constipation.
Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT. ⋯ These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).