Acute AppendicitisNCT04947748
Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous
A study testing Oral versus intravenous administration of antibacterial treatment in people with Acute Appendicitis and Acute Appendicitis With Rupture, run by North Estonia Medical Centre at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis Without Peritonitis
- What is being tested?
- Oral versus intravenous administration of antibacterial treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Nov 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with acute appendicitis and are candidates for laparoscopic appendectomy.
Who cannot join
- Patients with compromised immune system (HIV, diabetes), ongoing or completed radio-chemotherapy in past 5 years, prosthetic heart valve, vascular prosthesis, pregnancy.
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
North Estonia Medical Centre
Tallinn
Edgar Lipping, MD, 6171520, edgar.lipping@regionaalhaigla.ee
Sten Saar, MD, PhD, 6171520, sten.saar@regionaalhaigla.ee
About this study
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.
- Conditions
- Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis Without Peritonitis, Acute Appendicitis With Appendix Abscess, Appendicitis; Perforation, Appendicitis Perforated
- Being tested
- Oral versus intravenous administration of antibacterial treatment
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral versus intravenous administration of antibacterial treatmentOther
Mode of administration of antibacterial treatment
| Study group | Role | What they receive |
|---|---|---|
| 24 hour intravenous antibacterial therapy | Active comparator | S.Augmentin 1,2g x 3 i/v Receives: Other: Oral versus intravenous administration of antibacterial treatment |
| 24 hour oral antibacterial therapy | Experimental | T.Augmentin 1g x 3 p/o Receives: Other: Oral versus intravenous administration of antibacterial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Nov 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Estonia Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Tartu University Hospital
- Responsible party
- Sponsor
- Investigators
- Edgar Lipping, MD, Principal investigator, North Estonia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947748
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37747168
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous
- ClinicalTrials.gov ID
- NCT04947748
- Acronym / sponsor ID
- 1
- Conditions
- Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis Without Peritonitis, Acute Appendicitis With Appendix Abscess, Appendicitis; Perforation, Appendicitis Perforated
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- North Estonia Medical CentreUniversity, hospital or other
- Collaborators
- Tartu University Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| 24 hour intravenous antibacterial therapy | Active comparator | Other: Oral versus intravenous administration of antibacterial treatmentS.Augmentin 1,2g x 3 i/v |
| 24 hour oral antibacterial therapy | Experimental | Other: Oral versus intravenous administration of antibacterial treatmentT.Augmentin 1g x 3 p/o |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with acute appendicitis and are candidates for laparoscopic appendectomy.
Key exclusion criteria (1 listed)
- Patients with compromised immune system (HIV, diabetes), ongoing or completed radio-chemotherapy in past 5 years, prosthetic heart valve, vascular prosthesis, pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral versus intravenous administration of antibacterial treatmentMode of administration of antibacterial treatment | Other | 24 hour intravenous antibacterial therapy, 24 hour oral antibacterial therapy |
Primary outcome
Infectious complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 37747168Lipping 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.
- Individual participant dataSharing planned: Undecided
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar Lipping, MD principal investigator
North Estonia Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral versus intravenous administration of antibacterial treatment in people with Acute Appendicitis and Acute Appendicitis With Rupture, run by North Estonia Medical Centre at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edgar Lipping, MD (6171520, edgar.lipping@regionaalhaigla.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.