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Study of Conservative Versus Surgical Treatment of Appendicitis

G

Göteborg University

Status and phase

Completed
Phase 2

Conditions

Appendicitis

Treatments

Drug: cefotaxim and metronidazol

Study type

Interventional

Funder types

Other

Identifiers

NCT00469430
1-Hansson

Details and patient eligibility

About

The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.

Full description

Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. It is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction.

In our study we will compare antibiotic as the only treatment with traditional surgical treatment. Patients with "suspected appendicitis" are randomized to either surgery or antibiotics according to their birth date.

Patients in "the surgery group" are treated according to standard routines. Patients in "the antibiotic group" are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated.

Parameters that will be analyzed are:

  • primary healing in the antibiotic group
  • frequency of relapse in appendicitis in the antibiotic group
  • complications in both groups
  • economical analysis (hospital stay, sick leave time, time off work) in both groups

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Suspected appendicitis in patients over 18 years

Exclusion criteria

  • Under 18 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

360 participants in 2 patient groups

Op
No Intervention group
Description:
traditional surgery
Ab
Experimental group
Description:
antibiotic treatment
Treatment:
Drug: cefotaxim and metronidazol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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