Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicentre, Observational Study (PERFECT – Trial)

Objective To determine the prevalence of functional dyspepsia (FD) and irritable bowel syndrome (IBS) in patients eligible for cholecystectomy and to investigate the association between presence of FD/IBS and resolution of biliary colic and a pain-free state. Summary background data More than 30% of patients with symptomatic cholecystolithiasis reports persisting pain post-cholecystectomy. Co-existence of FD/IBS may contribute to this unsatisfactory outcome. Methods We conducted a multicentre, prospective, observational study (PERFECT-trial). Patients ≥18 years with abdominal pain and gallstones were included at five surgical outpatient clinics between 01/2018-04/2019. Follow-up was six months. Primary outcomes were prevalence of FD/IBS, and the difference between resolution of biliary colic and pain-free state in patients with and without FD/IBS. FD/IBS was defined by the Rome IV criteria, biliary colic by the Rome III criteria, and pain-free by an Izbicki Pain Score ≤10 and visual analogue scale ≤4. Results We included 401 patients with abdominal pain and gallstones (assumed eligible for cholecystectomy), mean age 52 years, 76% females. Of these, 34.9% fulfilled criteria for FD/IBS. 64.1% fulfilled criteria for biliary colic and 74.9% underwent cholecystectomy, with similar operation rates in patients with and without FD/IBS. Post-cholecystectomy, 6.1% of patients fulfilled criteria for biliary colic, with no significant difference between those with and without FD/IBS at baseline (4.9% vs. 8.6%, p = 0.22). Of all patients, 56.8% was pain-free after cholecystectomy, 40.7% of FD/IBS-group vs. 64.4% of no FD/IBS-group, p Conclusion One-third of patients eligible for cholecystectomy fulfil criteria for FD/IBS. Biliary colic is reported by only a few patients post-cholecystectomy, whereas non-biliary abdominal pain persists in >40%, particularly in those with FD/IBS pre-cholecystectomy. Clinicians should take these symptom-dependent outcomes into account in their shared decision making process. Trial registration The Netherlands Trial Register NTR-7307. Registered on 18 June 2018.