NCT04168866

Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.

Detailed description

Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.

Conditions

• Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Operative management	Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
OTHER	Drainage or antibiotics	If an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.

Timeline

• Start date: 2020-03-11
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2019-11-19
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States