Rozh Noel1, Urban Arnelo2, Lars Lundell2, Folke Hammarqvist2, Hanaz Jumaa3, Lars Enochsson4, Gabriel Sandblom5. 1. Division of Surgery, CLINTEC, Karolinska Institutet, Department of Surgery, Södertälje Hospital, Stockholm, Sweden. Electronic address: rozh.noel@sll.se. 2. Division of Surgery, CLINTEC, Karolinska Institutet, Center for Digestive Diseases, Karolinska University Hospital, Stockholm Sweden. 3. Department of Surgery, Mälarsjukhuset, Eskilstuna, Sweden. 4. Department of Surgical and Perioperative Sciences, Sunderby Research Unit, Umeå University, 971 80 Luleå, Sweden. 5. Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden; Department of Surgery, Södersjukhuset, Stockholm, Sweden.
Abstract
BACKGROUND:Delayed cholecystectomy is associated with increased risk of biliary events. The objectives of the study were to confirm the superiority of index cholecystectomy over delayed operation in mild gallstone pancreatitis. METHODS:Patients with mild gallstone pancreatitis were randomized into index-or delayed cholecystectomy (IC vs. DC). IC was performed within 48 h from randomization provided a stable or improved clinical condition. The primary outcome was gallstone-related events. Secondary outcomes were rates of cholecystectomy complications, common bile duct stones (CBDS) detected at cholecystectomy and patient reported quality-of-life and pain. RESULTS:Sixty-six patients were randomized into IC (n = 32) or DC (n = 34) between May 2009 and July 2017. There were significantly higher rates of gallstone-related events in the DC compared with the IC group (nine patients vs. one patient, p = 0.013). No statistically significant differences could be demonstrated in cholecystectomy complications (p = 0.605) and CBDS discovered during cholecystectomy (p = 0.302) between the groups. Pain and emotional well-being measured by SF-36 were improved significantly in the IC group at follow-up. CONCLUSIONS:Delayed cholecystectomy in mild gallstone pancreatitis can no longer be recommended since it is associated with an increased risk for recurrent gallstone-related events and impaired patient's reported outcomes. TRIAL REGISTRATION NUMBER: clinicaltrials.gov (ID: NCT02630433).
RCT Entities:
BACKGROUND: Delayed cholecystectomy is associated with increased risk of biliary events. The objectives of the study were to confirm the superiority of index cholecystectomy over delayed operation in mild gallstone pancreatitis. METHODS:Patients with mild gallstone pancreatitis were randomized into index-or delayed cholecystectomy (IC vs. DC). IC was performed within 48 h from randomization provided a stable or improved clinical condition. The primary outcome was gallstone-related events. Secondary outcomes were rates of cholecystectomy complications, common bile duct stones (CBDS) detected at cholecystectomy and patient reported quality-of-life and pain. RESULTS: Sixty-six patients were randomized into IC (n = 32) or DC (n = 34) between May 2009 and July 2017. There were significantly higher rates of gallstone-related events in the DC compared with the IC group (nine patients vs. one patient, p = 0.013). No statistically significant differences could be demonstrated in cholecystectomy complications (p = 0.605) and CBDS discovered during cholecystectomy (p = 0.302) between the groups. Pain and emotional well-being measured by SF-36 were improved significantly in the IC group at follow-up. CONCLUSIONS: Delayed cholecystectomy in mild gallstone pancreatitis can no longer be recommended since it is associated with an increased risk for recurrent gallstone-related events and impaired patient's reported outcomes. TRIAL REGISTRATION NUMBER: clinicaltrials.gov (ID: NCT02630433).
Authors: Pablo Giuffrida; David Biagiola; Agustín Cristiano; Victoria Ardiles; Martín de Santibañes; Rodrigo Sanchez Clariá; Juan Pekolj; Eduardo de Santibañes; Oscar Mazza Journal: Updates Surg Date: 2020-02-03
Authors: Madeleine Clout; Jane Blazeby; Chris Rogers; Barnaby Reeves; Michelle Lazaroo; Kerry Avery; Natalie S Blencowe; Ravi Vohra; Neil Jennings; William Hollingworth; Joanna Thorn; Marcus Jepson; Jane Collingwood; Ashley Guthrie; Elizabeth Booth; Samir Pathak; Ian Beckingham; Lucy Culliford; Ewen A Griffiths; Raneem Albazaz; Giles Toogood Journal: BMJ Open Date: 2021-06-29 Impact factor: 2.692