Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

NCT01022567 | Unknown Results

• 1 other identifier: APPAC
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 6

Brief Summary

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis. The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

• The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis

  A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.

  Up to 10 years

Secondary Outcomes (3)

• The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment

  1 year

• The Direct and Indirect Costs of Both Treatment Arms

  1 year

• The Recurrence of Conservatively Treated Appendicitis

  up to 10 years

Study Arms (2)

Operative treatment

ACTIVE COMPARATOR

Regular open appendicectomy

Procedure: Appendicectomy

Antibiotic treatment

ACTIVE COMPARATOR

Ertapenem 1 g i.v. x 1 three days

Drug: Ertapenem

Interventions

Appendicectomy PROCEDURE

Standard appendicectomy

Operative treatment

Ertapenem DRUG

ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.

Antibiotic treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range from 18 to 60 years
• CT scan diagnosed uncomplicated acute appendicitis

You may not qualify if:

• Age under 18 years or age over 60 years
• Pregnancy or breast-feeding
• Allergy to contrast media or iodine
• Renal insufficiency
• metformin medication (DM)
• Peritonitis (a perforated appendix)
• Lack of co-operation (unable to give consent)
• A severe other medical condition
• CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour

Sponsors & Collaborators

• Turku University Hospital: lead
• Oulu University Hospital: collaborator
• Tampere University Hospital: collaborator
• Mikkeli Central Hospital: collaborator
• Jyväskylä Central Hospital: collaborator
• Seinajoki Central Hospital: collaborator

Study Sites (6)

Keski-Suomi Central Hosptal

Jyväskylä, Finland

Location

Mikkeli Central Hospital

Mikkeli, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (7)

• Paajanen H, Gronroos JM, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Dean K, Jartti A, Mecklin JP, Sand J, Salminen P. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial). BMC Surg. 2013 Feb 8;13:3. doi: 10.1186/1471-2482-13-3.

  PMID: 23394263 BACKGROUND

• Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.

  PMID: 26080338 RESULT

• Salminen P, Salminen R, Kallio J, Hurme S, Nordstrom P, Rantanen T, Paajanen H, Aarnio M, Mecklin JP, Sand J, Gronroos JM, Rautio T. Antibiotic Therapy for Uncomplicated Acute Appendicitis: Ten-Year Follow-Up of the APPAC Randomized Clinical Trial. JAMA. 2026 Jan 21. doi: 10.1001/jama.2025.25921. Online ahead of print.

  PMID: 41563747 DERIVED

• Selanne L, Hurme S, Sippola S, Rautio T, Nordstrom P, Rantanen T, Pinta T, Ilves I, Mattila A, Savela EL, Rintala J, Paajanen H, Gronroos J, Haijanen J, Salminen P. Prognostic factors associated with primary non-responsiveness to antibiotics and appendicitis recurrence for CT-diagnosed uncomplicated acute appendicitis: secondary analysis of two randomized clinical trials. Br J Surg. 2025 Jul 3;112(7):znaf143. doi: 10.1093/bjs/znaf143.

  PMID: 40741675 DERIVED

• Sippola S, Haijanen J, Viinikainen L, Gronroos J, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Jartti A, Salminen P. Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):283-289. doi: 10.1001/jamasurg.2019.6028.

  PMID: 32074268 DERIVED

• Salminen P, Tuominen R, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Virtanen J, Jartti A, Gronroos JM. Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial. JAMA. 2018 Sep 25;320(12):1259-1265. doi: 10.1001/jama.2018.13201.

  PMID: 30264120 DERIVED

• Niiniviita H, Salminen P, Gronroos JM, Rinta-Kiikka I, Hurme S, Kiljunen T, Kulmala J, Teras M, Sippola S, Virtanen J. LOW-DOSE CT PROTOCOL OPTIMIZATION FOR THE ASSESSMENT OF ACUTE APPENDICITIS: THE OPTICAP PHANTOM STUDY. Radiat Prot Dosimetry. 2018 Jan 1;178(1):20-28. doi: 10.1093/rpd/ncx070.

  PMID: 28591824 DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy; Ertapenem

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paulina Salminen
• Organization: Turku University Hospital

paulina.salminen@tyks.fi

+358 2 313 0542

Study Officials

• Paulina Salminen, MD, PhD

  Department of surgery, Turku University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2025
• Last Updated: June 28, 2018
• Results First Posted: February 23, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (6)