Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous

June 24, 2021 updated by: North Estonia Medical Centre
Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous is a prospective randomized controlled trial comparing 24 hour intravenous antibacterial therapy to 24 hour oral antibacterial therapy after surgery in complicated appendicitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients diagnosed with acute appendicitis and are candidates for laparoscopic appendectomy.

Exclusion Criteria:

Patients with compromised immune system (HIV, diabetes), ongoing or completed radio-chemotherapy in past 5 years, prosthetic heart valve, vascular prosthesis, pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 24 hour intravenous antibacterial therapy
S.Augmentin 1,2g x 3 i/v
Other: Oral versus intravenous administration of antibacterial treatment
Mode of administration of antibacterial treatment
Experimental: 24 hour oral antibacterial therapy
T.Augmentin 1g x 3 p/o
Other: Oral versus intravenous administration of antibacterial treatment
Mode of administration of antibacterial treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infectious complications
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Estonia Medical Centre

Collaborators

Tartu University Hospital

Investigators

  • Principal Investigator: Edgar Lipping, MD, North Estonia Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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