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The Laparoscopic Appendicitis Score; a Multicenter Validation Study (APPLE)

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ClinicalTrials.gov Identifier: NCT02029781
Recruitment Status : Terminated (Delayed/poor inclusion rate.)
First Posted : January 8, 2014
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
University of Groningen
Information provided by (Responsible Party):
JW Haveman, University Medical Center Groningen

Brief Summary:

SUMMARY

Rationale: A diagnostic laparoscopy is a frequently used method to confirm the diagnosis appendicitis. However until recently evidence-based laparoscopic criteria for determining appendicitis were not defined. If there is any doubt about the presence of appendicitis the appendix is usually removed. In a single centre prospective pilot study on 134 patients the investigators were able to define the Laparoscopic APPendicitis (LAPP) score. In the current study the investigators will validate the LAPP score in order to decrease the negative appendectomy rate by 50%. Eventually the score should lead to a decrease in morbidity.

Objective: To decrease the negative appendectomy rate by 50%.

Study design: A multicenter prospective validation study

Study population: All patients, ≥18 years, operated with a diagnostic laparoscopy for the clinical suspicion appendicitis. Sample size calculation, performed by a statistician/ epidemiologist of the Trial Coordination Centre, showed the need to analyse 778 patients.

Intervention (if applicable): Patients operated on appendicitis in 2008 and 2009 (n=843), were retrospectively analysed for negative appendectomies. This cohort will serve as the control group. In this control group no intervention was given, as the LAPP score was not yet defined.

In the 778 prospective analysed patients, the LAPP score will be used during a diagnostic laparoscopy. With the LAPP score the investigators intend to halve the number of negative appendectomies.

Main study parameters/endpoints: A decrease in the negative appendectomy rate from 9% to 5%. This decrease should not lead to an increase in missed appendicitis (occurring within 30 days), defined as requiring a surgical re-intervention or as an appendicitis or appendicular infiltrate on an ultrasound or CT-scan.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of implementation of the LAPP score is minimal. In theory, the use of the LAPP score might lead to an increase risk in missed appendicitis. This might lead to an increase in morbidity.


Condition or disease Intervention/treatment Phase
Appendicitis Procedure: LAPP score Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: APPLE Study (APPendicitis and Laparoscopic Evaluation) Study; Multicenter Prospective Validation of the Laparoscopic APPendicitis (LAPP) Score
Study Start Date : September 2013
Actual Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arm Intervention/treatment
LAPP score
Use of the LAPP score during a diagnostic laparoscopy.
Procedure: LAPP score
Use of the LAPP score during a diagnostic laparoscopy.



Primary Outcome Measures :
  1. Negative appendectomy [ Time Frame: 3 months postoperatively ]
    Either a histologically proven normal appendix or in case of no appendectomy a 3 months disease free clinical course.


Secondary Outcome Measures :
  1. Missed appendicitis [ Time Frame: 3 months ]
    In case the appendix was not removed and the patients developed appendicitis or an infiltrate or appendicular abscess within 3 months after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients operated for the clinical suspicion of acute appendicitis that will undergo a diagnostic laparoscopy.
  • Age ≥ 18 years.
  • Written informed consent

Exclusion Criteria:

  • Diagnostic laparoscopy and planned appendectomy for an appendectomy a froid.
  • Primarily chosen for an open appendectomy.
  • Not able to give informed consent (for example language barrier or legally incapable).
  • Refused informed consent.

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): NCT02029781


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
University of Groningen

Responsible Party: JW Haveman, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02029781     History of Changes
Other Study ID Numbers: Apple study 2013
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by JW Haveman, University Medical Center Groningen:
Appendicitis
Laparoscopy
Appendectomy
Negative appendectomy
Morbidity

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases