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Completed

NCT Number: NCT00469430

Study of Conservative Versus Surgical Treatment of Appendicitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Göteborg University, Sahlgrenska Universitetssjukhuset

Gothenburg, Göteborg, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected appendicitis in patients over 18 years

Exclusion criteria

  • Under 18 years

Treatment and study plan

cefotaxim and metronidazol

Drug

iv administration for at least 24 h

Primary outcomes

  1. treatment efficacy

    Time frame: one year

Secondary outcomes

  1. complications

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
May 4, 2007
Registry last updated
Apr 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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