NCT04947748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

June 24, 2021

Last Update Submit

June 24, 2021

Conditions

Acute AppendicitisAcute Appendicitis With RuptureAcute Appendicitis Without PeritonitisAcute Appendicitis With Appendix AbscessAppendicitis; PerforationAppendicitis PerforatedAppendicitis Acute

Outcome Measures

Primary Outcomes (1)

  • Infectious complications

    30 days

Study Arms (2)

24 hour intravenous antibacterial therapy

ACTIVE COMPARATOR

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

Other: Oral versus intravenous administration of antibacterial treatment

24 hour oral antibacterial therapy

EXPERIMENTAL

T.Augmentin 1g x 3 p/o

Other: Oral versus intravenous administration of antibacterial treatment

Interventions

Oral versus intravenous administration of antibacterial treatmentOTHER

Mode of administration of antibacterial treatment

24 hour intravenous antibacterial therapy24 hour oral antibacterial therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Estonia Medical Centre

Tallinn, Estonia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37747168DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Edgar Lipping, MD

    North Estonia Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edgar Lipping, MD

CONTACT

6171520edgar.lipping@regionaalhaigla.ee

Sten Saar, MD, PhD

CONTACT

6171520sten.saar@regionaalhaigla.ee

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 1, 2021

Study Start

November 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations

ES(1)