Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03013686

The Treatment of Periappendicular Abscess After the Acute Phase

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

interval appendectomy

Procedure

Laparoscopic appendectomy

Follow-up with MRI

Procedure

Abdominal MRI

Primary outcomes

  1. Treatment success

    Time frame: One year after the intervention

    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

Secondary outcomes

  1. Possible appendiceal or colon tumours

    Time frame: 1-10 years

    The incidence of possible tumours

  2. Possible diagnosis of Crohn's disease

    Time frame: 1-10 years

    The incidence of possible Crohn's disease

  3. The length of hospital stay

    Time frame: up to one year

    Length of hospital stay

  4. Sick leave

    Time frame: up to one year

    Sick leave (days)

  5. Overall morbidity

    Time frame: Up to 10 years, time points 1, 3, 5 and 10 years

    Complications related to disease / intervention

  6. Mortality

    Time frame: Up to 10 years

    Mortality

  7. Treatment costs

    Time frame: Up to 10 years

    Overall treatment costs

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Oulu University Hospital

Registry information

Official study title

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

Acronym: PeriAPPAC

Important dates

Study start
2013
Primary completion
2017
Study completion
2030
First posted
Jan 6, 2017
Registry last updated
Nov 12, 2020

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.

Published trials that share one or more normalized conditions with this study.