Optimized treatment for uncomplicated acute appendicitis - active observation with or without antibiotic treatment. A phase IV consecutive clinical treatment trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001578-71-SE

Enrollment

320

Registered

2018-06-26

Start date

2018-07-30

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute appendicitis

Interventions

Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: Piperacillin Other descriptive name: PIPERACILLIN SODIUM Concentration unit: g gram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients presenting with symptoms of clinical acute appendicitis Age >18 =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Evident or suspected pregnancy Known allergic reaction towards penicillin or similar antibiotics Precence of intercurrent disease that are judged relevant for the patient Contraindications of antibiotic treatment (disease, medication or organ dysfunction) Dyscompliance (lack of id, language understnding etc.

Design outcomes

Primary

Measure	Time frame
Main Objective: Antibiotic is a safe and effective treatment of uncomplicated appendicitis, a fact that has been established in our own and in international studies. The results have however raised the question whether acute appendicitis can heal spontaneously in a majority of cases, thus making antibiotic administration a form of over-treatment. This approach has been used in Swedish hospitals through conservative treatment with active observation, and repeated clinical examinations to exclude the need of surgery. The present trial therefore aim to test if early antibiotic treatment is a more effective treatment option superior to active observation to avoid a surgical intervention in a selected group of patients with assumed acute appendicitis. ;Secondary Objective: Not applicable;Primary end point(s): Treatment failure. Evaluated as final proportion of patients in each group that need acute appendectomy, despite initial observation or observation+antibiotics. ;Timepoint(s) of evaluation of this end point: At 30 Days and 1 year following inclusion.	—

Measure

Time frame

Main Objective: Antibiotic is a safe and effective treatment of uncomplicated appendicitis, a fact that has been established in our own and in international studies. The results have however raised the question whether acute appendicitis can heal spontaneously in a majority of cases, thus making antibiotic administration a form of over-treatment. This approach has been used in Swedish hospitals through conservative treatment with active observation, and repeated clinical examinations to exclude the need of surgery. The present trial therefore aim to test if early antibiotic treatment is a more effective treatment option superior to active observation to avoid a surgical intervention in a selected group of patients with assumed acute appendicitis. ;Secondary Objective: Not applicable;Primary end point(s): Treatment failure. Evaluated as final proportion of patients in each group that need acute appendectomy, despite initial observation or observation+antibiotics. ;Timepoint(s) of evaluation of this end point: At 30 Days and 1 year following inclusion.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactKir.Metabol lab

Göteborgs Universitet

kent.lundholm@surgery.gu.se463134210003678

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026