ABSTRACT
BACKGROUND: Two strategies for same-admission cholecystectomy in mild gallstone pancreatitis (MGP) exist: early surgery (within 48-72 h from admission) and delayed surgery until resolution of symptoms and normalization of pancreatic tests. METHODS: This was a single-center, open-label RCT. Patients with MGP according to revised Atlanta classification-2012 and SIRS criteria were randomly assigned to early laparoscopic cholecystectomy (E-LC) within 72 h from admission or delayed laparoscopic cholecystectomy (D-LC). Laparoscopic-endoscopic rendezvous was performed when common bile duct stones were found at systematic intraoperative cholangiography. The primary outcome was length of stay (LOS), and the secondary outcomes were complications at 90 days, need for ERCP/choledocolithiasis, conversion, and re-admission. One year of follow-up was carried-on. RESULTS: At interim analysis, 52 patients were randomized (26 E-LC, 26 D-LC). E-LC versus D-LC was associated with a significantly shorter LOS (median 58 versus 167 h; P = 0.001). There were no differences in ERCP necessity for choledocolithiasis between the two approaches (E-LC 26.9% versus D-LC 23.1%, P = 1.00). No differences in postoperative complications were found. CONCLUSIONS: E-LC approach in patients with MGP significantly reduced LOS and was not associated with clinically relevant postoperative complications. TRIAL REGISTRATION: clinicaltrials.gov (NCT02590978).
Subject(s)
Cholecystectomy, Laparoscopic , Gallstones/surgery , Length of Stay , Pancreatitis/surgery , Postoperative Complications/epidemiology , Time-to-Treatment , Adult , Aged , Cholangiopancreatography, Endoscopic Retrograde , Choledocholithiasis/diagnosis , Choledocholithiasis/epidemiology , Female , Gallstones/complications , Gallstones/diagnosis , Humans , Male , Middle Aged , Pancreatitis/complications , Pancreatitis/diagnosis , Patient Readmission , Postoperative Complications/diagnosis , Severity of Illness Index , Treatment Outcome , Young AdultABSTRACT
OBJECTIVE: To evaluate a new magnetic surgical system during reduced-port laparoscopic cholecystectomy in a prospective, multicenter clinical trial. BACKGROUND: Laparoscopic instrumentation coupled by magnetic fields may enhance surgeon performance by allowing for shaft-less retraction and mobilization. The movements can be performed under direct visualization, generating different angles of traction and reducing the number of trocars to perform the procedure. This may reduce well-known associated complications of trocars, including incisional pain, scarring, infection, bowel, and vascular injuries, among others. METHODS: A prospective, multicenter, single-arm, open-label study was performed to assess the safety and performance of a magnetic surgical system (Levita Magnetics' Surgical System). The investigational device was used during a 3-port laparoscopic technique. The primary endpoints evaluated were safety and feasibility of the device to adequately mobilize the gallbladder to achieve effective exposure of the targeted surgical site. Patients were followed for 30 days postprocedure. RESULTS: Between January 2014 and March 2015, 50 patients presenting with benign gallbladder disease were recruited. Forty-five women and 5 men with an average age of 39 years (18-59), average body mass index of 27 kg/m (20.4-34.1) and an average abdominal wall thickness of 2.6 cm (1.8-4.6). The procedures were successfully performed in all 50 patients. No device-related serious adverse events were reported. Surgeons rated as "excellent" (90%) or "sufficient" (10%) the exposure of the surgical site. CONCLUSIONS: This clinical trial shows that this new magnetic surgical system is safe and effective in reduced-port laparoscopic cholecystectomy.