The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC)

The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC): a Randomized Clinical Trial Interval Appendectomy Versus Follow-up

The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic appendectomy with follow-up MRI in patients with initially successfully treated periappendicular abscess.

Periappendicular abscess is generally initially treated conservatively with antibiotic therapy and if necessary, drainage. Operative treatment in the acute abscess phase is associated with increased morbidity and thus complicated appendicitis with a periappendicular abscess is initially treated conservatively. However, there is debate on whether interval appendectomy is required.

After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular abscess, patients enrolled in the PeriAPPAC study are randomised either to interval appendectomy or to follow-up with MRI at two months after the initial treatment. All patients also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the MRI (outpatient visit at endoscopy unit with information on the MRI).

The primary endpoint is the treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up.

The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital and Seinäjoki Central Hospital.

Study Overview

• Status: Active, not recruiting
• Conditions: Periappendicular Abscess
• Intervention / Treatment: Procedure: Interval appendectomy; Procedure: Follow-up with MRI

Detailed Description

The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic appendectomy with follow-up MRI in patients with initially successfully treated periappendicular abscess.

Periappendicular abscess is generally initially treated conservatively with antibiotic therapy and if necessary, drainage. Operative treatment in the acute abscess phase is associated with increased morbidity and thus complicated appendicitis with a periappendicular abscess is initially treated conservatively. However, there is debate on whether interval appendectomy is required.

After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular abscess, patients enrolled in the PeriAPPAC study are randomised either to interval appendectomy or to follow-up with MRI at two months after the initial treatment. All patients also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the MRI (outpatient visit at endoscopy unit with information on the MRI).

The primary endpoint is the treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up.

The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital and Seinäjoki Central Hospital.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-60 years
• CT- or MRI-diagnosed periappendicular abscess, that has initially undergone successful conservative treatment with antibiotic therapy and drainage, if necessary

Exclusion Criteria:

• Suspicion of a tumour on CT or MRI
• Age under 18 years or over 60 years
• Pregnancy or lactating
• Allergy to contrast media or iodine
• Renal insufficiency
• Metformin medication (DM)
• Unsuccessful initial conservative treatment of periappendicular abscess
• Lack of co-operation (unable to give consent)
• A severe medical condition
• Previous acute appendicitis treated conservatively with antibiotics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interval Appendectomy; The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary. Interval appendectomy is performed at two months after the primary treatment, all patients also undergo colonoscopy prior to appendectomy.	Procedure: Interval appendectomy; Laparoscopic appendectomy
Active Comparator: Follow-up with MRI; The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary. The patients undergo abdominal magnetic resonance imaging at two months after the primary treatment, all patients also undergo colonoscopy right after the MRI.	Procedure: Follow-up with MRI; Abdominal MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	Treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and successful appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up	One year after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Possible appendiceal or colon tumours	The incidence of possible tumours	1-10 years
Possible diagnosis of Crohn's disease	The incidence of possible Crohn's disease	1-10 years
The length of hospital stay	Length of hospital stay	up to one year
Sick leave	Sick leave (days)	up to one year
Overall morbidity	Complications related to disease / intervention	Up to 10 years, time points 1, 3, 5 and 10 years
Mortality	Mortality	Up to 10 years
Treatment costs	Overall treatment costs	Up to 10 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Oulu University Hospital
• Investigators: Principal Investigator: Paulina Salminen, MD, PhD, Turku University Hospital

Publications and helpful links

General Publications

• Mallinen J, Rautio T, Gronroos J, Rantanen T, Nordstrom P, Savolainen H, Ohtonen P, Hurme S, Salminen P. Risk of Appendiceal Neoplasm in Periappendicular Abscess in Patients Treated With Interval Appendectomy vs Follow-up With Magnetic Resonance Imaging: 1-Year Outcomes of the Peri-Appendicitis Acuta Randomized Clinical Trial. JAMA Surg. 2019 Mar 1;154(3):200-207. doi: 10.1001/jamasurg.2018.4373.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2013
• Primary Completion (Actual): September 30, 2017
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: PeriAPPAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No