Long-term follow-up of a randomized controlled trial of observation versus surgery for acute cholecystitis: Non-operative management is an option in some patients

Abstract

Background. Cholecystectomy is routinely recommended to prevent recurrent disease after an initial episode of acute cholecystitis. Therefore, randomized controlled trials have mainly focused on the timing of surgery, but many patients scheduled for cholecystectomy have deferred surgery with long periods of symptom-free intervals. Our present aim is to examine the long-term feasibility and safety of observation compared with surgery. Methods. Trial of 64 patients with acute cholecystitis previously randomized to observation or cholecystectomy, which examined outcome in terms of completed randomized treatment and appearance of further symptoms and the need for surgical treatment. Thirty-three patients were randomized to observation and 31 patients to cholecystectomy. Median follow-up was 14 years. Results. Of the 33 patients randomized to observation, 11 (33%) experienced a new event of gallstone-related disease (eight (24.2%) had acute cholecystitis) and 11 (33%) were operated. No significant difference (p = 0.565) was found between the two randomized groups with regard to recurrent disease or complications. Virtually no surgery took place after 5 years of follow-up. The difference in completed randomized treatment between the groups was not significant (p = 0.077). Long-term mortality was equal in those operated and in those observed. Conclusions. Twenty-four percent of the patients experienced recurrent cholecystitis, but escalation of disease severity or increased mortality was not observed. Long-term observation after acute cholecystitis was feasible in two-thirds of the patients as the risk for recurrent disease was negligible after 5 years.

Key Words::

• Biliary-clinical
• hepatobiliary-clinical
• laparoscopy

Acknowledgments

The initial phase of the studies was supported by a scholarship from the Centre for Clinical Research, Haukeland University Hospital. The Research Council of Norway, the Research Committee of Stavanger University Hospital, the University of Bergen, Helga Semb's Foundation, and Karla and Arne Oddmar's Foundation gave financial support. We acknowledge the supportive collaboration of the staff at the participating hospitals at the start of the studies. The concluding phase of the studies was given financial support by Haraldsplass Deaconal Hospital and Western Norway Regional Health Authorities through the Centre for Clinical Research at Haukeland University Hospital. The authors are grateful for Professor Odd Søreide's contribution to the earlier phase of this study and to the Department of Surgery at Haukeland University Hospital for allowing us to follow up the patients treated at their hospital. We express our gratitude to Dr. John A. Dumot at the Digestive Disease Institute, Cleveland Clinic Foundation, Ohio, for linguistic advice with the manuscript.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.