Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 1\. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
Locations
United States
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Contact Information
Primary
Kevin Schuster, MD, MPH
kevin.schuster@yale.edu
203 785 2572
Time Frame
Start Date: 2020-03-11
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 180
Treatments
Experimental: Surgery
Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures.
Active_comparator: Non-operative management
If a patient chooses non-operative management and 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.
Related Therapeutic Areas
Sponsors
Leads: Yale University