NCT04780737

Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy

Detailed description

This is a retrospective study based on 230 Si-NENs candidates to the primary tumor resection. Patients were divided into two arms: PC and OC. Propensity score matching was performed, reporting the d value. The primary outcome was the re-hospitalization rate for any cause. The secondary endpoints were the re-hospitalization rate for biliary stone disease (BSD), the mean number of re-hospitalization (any cause and BSD), the complication rate (all and severe), and the total costs. A P-value \< 0.05 was considered significant, and NNT\< 10 was considered clinically relevant.

Conditions

• Neuroendocrine Tumors
• Surgery
• Gut Tumor

Interventions

Type	Name	Description
PROCEDURE	Cholecystectomy	Laparoscopic or laparotomic cholecystectomy

Timeline

• Start date: 2000-01-01
• Primary completion: 2019-12-01
• Completion: 2020-07-01
• First posted: 2021-03-03
• Last updated: 2021-03-03