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

Primary Purpose

Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis Without Peritonitis

Status

Unknown status

Phase

Not Applicable

Locations

Estonia

Study Type

Interventional

Intervention

Oral versus intravenous administration of antibacterial treatment

About this trial

This is an interventional treatment trial for Acute Appendicitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

North Estonia Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

24 hour intravenous antibacterial therapy

24 hour oral antibacterial therapy

Arm Description

S.Augmentin 1,2g x 3 i/v

T.Augmentin 1g x 3 p/o

Outcomes

Primary Outcome Measures

Infectious complications

Secondary Outcome Measures

Full Information

NCT ID

NCT04947748

First Posted

June 24, 2021

Last Updated

June 24, 2021

Sponsor

North Estonia Medical Centre

Collaborators

Tartu University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04947748

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

North Estonia Medical Centre

Collaborators

Tartu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis Without Peritonitis, Acute Appendicitis With Appendix Abscess, Appendicitis; Perforation, Appendicitis Perforated, Appendicitis Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

RCT

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

24 hour intravenous antibacterial therapy

Arm Type

Active Comparator

Arm Description

S.Augmentin 1,2g x 3 i/v

Arm Title

24 hour oral antibacterial therapy

Arm Type

Experimental

Arm Description

T.Augmentin 1g x 3 p/o

Intervention Type

Other

Intervention Name(s)

Oral versus intravenous administration of antibacterial treatment

Intervention Description

Mode of administration of antibacterial treatment

Primary Outcome Measure Information:

Title

Infectious complications

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Edgar Lipping, MD

Phone

6171520

edgar.lipping@regionaalhaigla.ee

First Name & Middle Initial & Last Name or Official Title & Degree

Sten Saar, MD, PhD

Phone

6171520

sten.saar@regionaalhaigla.ee

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edgar Lipping, MD

Organizational Affiliation

North Estonia Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

North Estonia Medical Centre

City

Tallin

Country

Estonia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edgar Lipping, MD

Phone

6171520

edgar.lipping@regionaalhaigla.ee

First Name & Middle Initial & Last Name & Degree

Sten Saar, MD, PhD

Phone

6171520

sten.saar@regionaalhaigla.ee

First Name & Middle Initial & Last Name & Degree

Edgar Lipping, MD

First Name & Middle Initial & Last Name & Degree

Sten Saar, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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