The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic) study: Multicenter randomized, double-blind, controlled trial of laparoscopic (LC) versus open (LTC) surgery for acute cholecystitis (AC) in adults

Abstract

Background: In some randomized trials successful laparoscopic cholecystectomy for cholecystitis is associated with an earlier recovery and shorter hospital stay when compared with open cholecystectomy. Other studies did not confirm these results and showed that the potential advantages of laparoscopic cholecystectomy for cholecystitis can be offset by a high conversion rate to open surgery. Moreover in these studies a similar postoperative programme to optimize recovery comparing laparoscopic and open approaches was not standardized. These studies also do not report all eligible patients and are not double blinded.

Open versus laparoscopic cholecystectomy in acute cholecystitis. Systematic review and meta-analysis

“…Only one study (25) reported common bile duct injuries with 1 injury for each group among 200 cholecystectomies. The other 3 studies [13,23,27] reported no bile duct injuries.…”

“…Four studies reported data on bile leakage [23,26,28,29] and only one was randomized [23]. 326 patients were treated with OC and 343 with LC (Fig.…”

Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis

“…A search of the literature published between January 2013 and December 2016, after the publication of TG13, and using the keywords “acute cholecystitis,” “laparoscopic cholecystectomy,” and “open cholecystectomy” returned papers on one systematic review and one randomized controlled trial. In terms of the incidence of surgical complications, the team producing these guidelines performed a meta‐analysis using a random‐effects model on four randomized controlled studies because the systematic review used a fixed‐effects model even though various differences in the research papers were detected. The odds ratio for the incidence of surgical complications is 0.34 (95% CI: 0.07–1.60), which suggests that laparoscopic surgery may be effective but the difference between Lap‐C and open cholecystectomy is not statistically significant (Fig.…”

Laparoscopic cholecystectomy: consensus conference-based guidelines

“…The populationbased outcome research showed also lower morbidity and mortality [103]. An additional trial, published after that consensus [104], confirmed those findings. A further randomized controlled study demonstrated that the laparoscopic cholecystectomy caused less surgical trauma and immunosuppression (by measuring serum C-reactive protein and tumor necrosis factor-a -TNF-a-secretion of peripheral blood mononuclear cells) and also confirmed that it was associated with a shorter hospital stay [105] (LE2).…”