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Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

Primary Purpose

Acute Uncomplicated Appendicitis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
1 gm IV ertapenem at enrollment
1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days
Appendectomy
Sponsored by
Olive View-UCLA Education & Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Uncomplicated Appendicitis focused on measuring appendicitis, non operative management, appendectomy

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult or child ages ≥5 years;
  • Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;
  • Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and
  • Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria:

  • instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

Sites / Locations

  • Olive View-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antibiotics

Appendectomy

Arm Description

Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.

Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.

Outcomes

Primary Outcome Measures

Major Complications
The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.

Secondary Outcome Measures

Recurrent appendicitis
QOL outcomes

Full Information

First Posted
May 14, 2015
Last Updated
April 8, 2018
Sponsor
Olive View-UCLA Education & Research Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02447224
Brief Title
Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis
Official Title
A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Olive View-UCLA Education & Research Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.
Detailed Description
This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Uncomplicated Appendicitis
Keywords
appendicitis, non operative management, appendectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.
Arm Title
Appendectomy
Arm Type
Active Comparator
Arm Description
Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.
Intervention Type
Drug
Intervention Name(s)
1 gm IV ertapenem at enrollment
Intervention Type
Drug
Intervention Name(s)
1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days
Intervention Type
Procedure
Intervention Name(s)
Appendectomy
Primary Outcome Measure Information:
Title
Major Complications
Description
The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Recurrent appendicitis
Time Frame
30 days
Title
QOL outcomes
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult or child ages ≥5 years; Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon; Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and Negative pregnancy test for subjects who are women of childbearing potential. Exclusion Criteria: instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.
Facility Information:
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

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