Operative management for Appendicitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
AppendicitisOperative management - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare early surgery to non-operative management for people with appendicitis who also have an infection.

Treatment Effectiveness

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: More than 7 days after index admission but within 60 days of randomization.

30 days after randomization.
Gastrointestinal (GI) quality of life
Day 60
Intra-abdominal abscess
One year after randomization.
GI quality of life
Day 60
Complications
Days of disability
Failed attempted procedure.
Need for bowel resection
Need for bowel resection.
Number of hospital days
Number of interventions for abscess
Within one year of index admission.
Occurrence of delayed appendectomy
Presence of malignancy in any resected specimen
Recurrence
Within one year of the index admission.
Need for additional intervention for appendicitis

Trial Safety

Trial Design

2 Treatment Groups

Non-operative management
1 of 2
Surgery
1 of 2

Active Control

Experimental Treatment

180 Total Participants · 2 Treatment Groups

Primary Treatment: Operative management · No Placebo Group · N/A

Surgery
Procedure
Experimental Group · 1 Intervention: Operative management · Intervention Types: Procedure
Non-operative management
Other
ActiveComparator Group · 1 Intervention: Drainage or antibiotics · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Operative management
2012
N/A
~230

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: more than 7 days after index admission but within 60 days of randomization.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,679 Previous Clinical Trials
21,087,873 Total Patients Enrolled
1 Trials studying Appendicitis
20 Patients Enrolled for Appendicitis

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: