Q&A

Watchful waiting is reasonable for gallstone symptoms

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  • BACKGROUND: Do all patients with symptomatic gallstone disease require surgery? Patients with symptomatic gallstones routinely undergo surgery. However, evidence for this treatment is based solely on expert opinion.
  • POPULATION STUDIED: The patients in this study were 137 adult, nonpregnant persons with episodic abdominal pain consistent with gallstone disease who presented to outpatient surgery clinics. The researchers confirmed the clinical diagnosis of gallstone disease with ultrasound. The study included 112 women, 20 to 77 years of age, and 25 men, 27 to 79 years. Of the 338 patients initially considered for the study, 45 were excluded based on defined exclusion criteria (younger than 18 years or older than 80 years, pregnancy, serious comorbid illness, or suspected common bile duct stone). Researchers excluded another 156 patients because of severe symptoms (n=54), patient preference for treatment (n=79), and undefined reasons (n=23).
  • STUDY DESIGN AND VALIDITY: The researchers randomized 137 patients to a cholecystectomy or an observation group. Patients assigned to surgery were operated on as soon as possible. Those assigned to observation received information about their disease and were instructed to avoid foods that aggravated their symptoms. The researchers followed up with patients for a median of 67 months (range, 56–91 months) and lost 1 patient to follow-up in that time.
  • OUTCOMES MEASURED: The primary outcome was the cumulative risk of having a cholecystectomy. Other outcomes measured were complications of gallstone disease and surgery.
  • RESULTS: Thirty-five of 69 patients (51%) randomized to the observation group eventually had cholecystectomies. Sixty of 68 patients (88%) randomized to the cholecystectomy group actually underwent surgery. The risk of having the surgery leveled off after 3 to 4 years. Complications were rare, with 12 of 69 observation patients (17%) and 2 of 68 surgery patients (3%) being admitted for biliary pain during follow-up. Gallstone-related complications (acute cholecystitis, common bile duct stones, or acute pancreatitis) occurred in 3 of the observation patients and 1 of the surgery patients.


 

PRACTICE RECOMMENDATIONS

Not all patients with symptomatic cholelithiasis require surgery. Nearly half of patients with symptomatic but uncomplicated gallstone disease can be managed successfully with observation and minor dietary changes. This option is a safe one we can offer our patients.