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

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ClinicalTrials.gov Identifier: NCT03013686
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
Paulina Salminen, Turku University Hospital

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.


Condition or disease Intervention/treatment Phase
Periappendicular Abscess Procedure: Interval appendectomy Procedure: Follow-up with MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC): a Randomized Clinical Trial Interval Appendectomy Versus Follow-up
Study Start Date : February 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013686


Sponsors and Collaborators
Turku University Hospital
Oulu University Hospital
Investigators
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Principal Investigator: Paulina Salminen, MD, PhD Turku University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulina Salminen, Principal investigator, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03013686    
Other Study ID Numbers: PeriAPPAC
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Abscess
Suppuration
Infection
Inflammation
Pathologic Processes