APPAC: Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

• Sponsor: Turku University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01022567
• Collaborator: Oulu University Hospital (Other), Tampere University Hospital (Other), Mikkeli Central Hospital (Other), Jyväskylä Central Hospital (Other), Seinajoki Central Hospital (Other)
• Enrollment: 530
• Locations: 6
• Arms: 2
• Duration (Months): 193
• Patients Per Site: 88.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Appendicitis	Procedure: Appendicectomy; Drug: Ertapenem	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 530 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Operative treatment Regular open appendicectomy	Procedure: Appendicectomy; Standard appendicectomy
Active Comparator: Antibiotic treatment Ertapenem 1 g i.v. x 1 three days	Drug: Ertapenem; 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.

Outcome Measures

Primary Outcome Measures

1. The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis [Up to 10 years]

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

Secondary Outcome Measures

1. The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment [1 year]

2. The Direct and Indirect Costs of Both Treatment Arms [1 year]

3. The Recurrence of Conservatively Treated Appendicitis [up to 10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age range from 18 to 60 years

• CT scan diagnosed uncomplicated acute appendicitis

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keski-Suomi Central Hosptal	Jyväskylä		Finland
2	Mikkeli Central Hospital	Mikkeli		Finland
3	Oulu University Hospital	Oulu		Finland
4	Seinäjoki Central Hospital	Seinäjoki		Finland
5	Tampere University Hospital	Tampere		Finland
6	Turku University Hospital	Turku		Finland

Sponsors and Collaborators

• Turku University Hospital
• Oulu University Hospital
• Tampere University Hospital
• Mikkeli Central Hospital
• Jyväskylä Central Hospital
• Seinajoki Central Hospital

Investigators

• Principal Investigator: Paulina Salminen, MD, PhD, Department of surgery, Turku University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Paajanen H, Grönroos JM, Rautio T, Nordström 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.

• Responsible Party: Paulina Salminen, MD, PhD, Turku University Hospital
• ClinicalTrials.gov Identifier: NCT01022567
• Other Study ID Numbers: APPAC
• First Posted: Dec 1, 2009
• Last Update Posted: Jun 28, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Appendicitis; Ertapenem

Study Results

Participant Flow

Arm/Group Title	Appendectomy	Antibiotic Therapy
Arm/Group Description	Open appendectomy	Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.
Period Title: Overall Study
STARTED	273	257
COMPLETED	272	242
NOT COMPLETED	1	15

Baseline Characteristics

Arm/Group Title	Operative Treatment	Antibiotic Treatment	Total
Arm/Group Description	Regular open appendicectomy Appendicectomy: Standard appendicectomy	Ertapenem 1 g i.v. x 1 three days Ertapenem: 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.	Total of all reporting groups
Overall Participants	273	257	530
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	273 100%	257 100%	530 100%
>=65 years	0 0%	0 0%	0 0%
Sex/Gender, Customized (participants) [Number]
Female	99 36.3%	102 39.7%	201 37.9%
Male	174 63.7%	155 60.3%	329 62.1%
Region of Enrollment (participants) [Number]
Finland	273 100%	257 100%	530 100%

Outcome Measures

1. Primary Outcome

Title	The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
Description	A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Time Frame	Up to 10 years

Outcome Measure Data

Analysis Population Description

Treatment success

Arm/Group Title	Appendectomy	Antibiotic Therapy
Arm/Group Description
Measure Participants	273	257
Number (95% Confidence Interval) [percentage of successful treatment]	99.6	72.7

2. Secondary Outcome

Title	The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	The Direct and Indirect Costs of Both Treatment Arms
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	The Recurrence of Conservatively Treated Appendicitis
Time Frame	up to 10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Appendectomy		Antibiotic Therapy
Arm/Group Description	Open appendectomy		Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days
All Cause Mortality
	Appendectomy		Antibiotic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Appendectomy		Antibiotic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/273 (0%)		0/257 (0%)
Other (Not Including Serious) Adverse Events
	Appendectomy		Antibiotic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/273 (16.5%)		6/257 (2.3%)
Infections and infestations
Overall morbidity	45/273 (16.5%)		6/257 (2.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.