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

NCT ID: NCT04947748

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24 hour intravenous antibacterial therapy

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

Group Type ACTIVE_COMPARATOR

Oral versus intravenous administration of antibacterial treatment

Intervention Type OTHER

Mode of administration of antibacterial treatment

24 hour oral antibacterial therapy

T.Augmentin 1g x 3 p/o

Group Type EXPERIMENTAL

Oral versus intravenous administration of antibacterial treatment

Intervention Type OTHER

Mode of administration of antibacterial treatment

Interventions

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Oral versus intravenous administration of antibacterial treatment

Mode of administration of antibacterial treatment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tartu University Hospital

OTHER

Sponsor Role collaborator

North Estonia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edgar Lipping, MD

Role: PRINCIPAL_INVESTIGATOR

North Estonia Medical Centre

Locations

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North Estonia Medical Centre

Tallinn, , Estonia

Site Status RECRUITING

Countries

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Estonia

Central Contacts

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Edgar Lipping, MD

Role: CONTACT

Sten Saar, MD, PhD

Role: CONTACT

Facility Contacts

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Edgar Lipping, MD

Role: primary

Sten Saar, MD, PhD

Role: backup

References

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Lipping E, Saar S, Reinsoo A, Bahhir A, Kirsimagi U, Lepner U, Talving P. Short Postoperative Intravenous Versus Oral Antibacterial Therapy in Complicated Acute Appendicitis: A Pilot Noninferiority Randomized Trial. Ann Surg. 2024 Feb 1;279(2):191-195. doi: 10.1097/SLA.0000000000006103. Epub 2023 Sep 25.

Reference Type DERIVED
PMID: 37747168 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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