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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Medical Centre Groningen
Sponsor:
Collaborator:
University of Groningen
Information provided by (Responsible Party):
JW Haveman, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT02029781
First received: January 6, 2014
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 Intervention
Appendicitis
Procedure: LAPP score

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: APPLE Study (APPendicitis and Laparoscopic Evaluation) Study; Multicenter Prospective Validation of the Laparoscopic APPendicitis (LAPP) Score

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

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


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


Estimated Enrollment: 778
Study Start Date: September 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LAPP score
Use of the LAPP score during a diagnostic laparoscopy.
Procedure: LAPP score
Use of the LAPP score during a diagnostic laparoscopy.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029781

Contacts
Contact: Jan Willem Haveman, MD PHD 0031 503612283 j.w.haveman@umcg.nl
Contact: Jenneke TH Hamminga 0031 50 3614437 j.t.h.hamminga@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: Jan Willem Haveman, MD PhD    0031 50 3612283    j.w.haveman@umcg.nl   
Principal Investigator: Jan Willem Haveman, MD, PhD         
Sponsors and Collaborators
University Medical Centre Groningen
University of Groningen
  More Information

No publications provided

Responsible Party: JW Haveman, MD, PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT02029781     History of Changes
Other Study ID Numbers: Apple study 2013
Study First Received: January 6, 2014
Last Updated: January 14, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Appendicitis
Laparoscopy
Appendectomy
Negative appendectomy
Morbidity

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014