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

Sponsor

North Estonia Medical Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04947748

Collaborator

Tartu University Hospital (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Appendicitis Acute Appendicitis With Rupture Acute Appendicitis Without Peritonitis Acute Appendicitis With Appendix Abscess Appendicitis; Perforation Appendicitis Perforated Appendicitis Acute	Other: Oral versus intravenous administration of antibacterial treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RCTRCT

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Infectious complications [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Estonia Medical Centre	Tallin		Estonia

Sponsors and Collaborators

North Estonia Medical Centre
Tartu University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

North Estonia Medical Centre

ClinicalTrials.gov Identifier:

NCT04947748

Other Study ID Numbers:

First Posted:

Jul 1, 2021

Last Update Posted:

Jul 1, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anti-Bacterial Agents

Study Results

No Results Posted as of Jul 1, 2021