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Acute Appendicitis: Active Observation With and Without Antibiotics

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).
Active observation
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with suspected appendicitis.
  • Age<60 years.
  • C-reactive protein < 60 mg/L.
  • White blod cell Count (leucocytes) < 13 e9 /L.

Exclusion criteria:

  • Pregnant

Sites / Locations

  • Department of surgery, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Antibiotic treatment

Clinical observation

Arm Description

Patients will receive in-hospital intravenous antibiotics (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). Surgery if no symptom relif occur.

Patients are followed by in-hospital "Active observation" (watchful waiting) according to clinical routine. Patients are observed until either, recovery and dismissal from hospital, or decision for intervention (surgery) is taken.

Outcomes

Primary Outcome Measures

Number of participants with no symptom relief
No symptom relief and surgery is deemed necessary.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2018
Last Updated
August 13, 2022
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT03985514
Brief Title
Acute Appendicitis: Active Observation With and Without Antibiotics
Official Title
Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluates if early provision of antibiotics is a superior treatment compared to "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated appendicitis.
Detailed Description
Recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence. However, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital conditions. A certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective. The hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Selected patients with assumed uncomplicated acute appendicitis are allocated to groups "Active observation" or "Antibiotic treatment" in a 1:1 ratio.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic treatment
Arm Type
Active Comparator
Arm Description
Patients will receive in-hospital intravenous antibiotics (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). Surgery if no symptom relif occur.
Arm Title
Clinical observation
Arm Type
Other
Arm Description
Patients are followed by in-hospital "Active observation" (watchful waiting) according to clinical routine. Patients are observed until either, recovery and dismissal from hospital, or decision for intervention (surgery) is taken.
Intervention Type
Drug
Intervention Name(s)
Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).
Other Intervention Name(s)
Piperacillin/Tazobactam, Ciprofloxacin, Flagyl
Intervention Description
Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.
Intervention Type
Other
Intervention Name(s)
Active observation
Intervention Description
In-hospital observation without antibiotics
Primary Outcome Measure Information:
Title
Number of participants with no symptom relief
Description
No symptom relief and surgery is deemed necessary.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with suspected appendicitis. Age<60 years. C-reactive protein < 60 mg/L. White blod cell Count (leucocytes) < 13 e9 /L. Exclusion criteria: Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Lundholm, Professor
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of surgery, Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acute Appendicitis: Active Observation With and Without Antibiotics

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