The Treatment of Periappendicular Abscess After the Acute Phase

NCT03013686 | Active Not Recruiting

• 1 other identifier: PeriAPPAC
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periappendicular Abscess

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Possible appendiceal or colon tumours

  1-10 years

• Possible diagnosis of Crohn's disease

  1-10 years

• The length of hospital stay

  up to one year

• Sick leave

  up to one year

• Overall morbidity

  Up to 10 years, time points 1, 3, 5 and 10 years

Study Arms (2)

Interval Appendectomy

ACTIVE COMPARATOR

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

Follow-up with MRI

ACTIVE COMPARATOR

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

Interventions

Interval appendectomy PROCEDURE

Laparoscopic appendectomy

Interval Appendectomy

Follow-up with MRI PROCEDURE

Abdominal MRI

Follow-up with MRI

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• Oulu University Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 30484824 DERIVED

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Paulina Salminen, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

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: Principal investigator

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: January 6, 2017
• Study Start: January 15, 2013
• Primary Completion: September 30, 2017
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share