NCT02029781

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2.7 years

First QC Date

January 6, 2014

Last Update Submit

May 29, 2016

Conditions

Appendicitis

Keywords

AppendicitisLaparoscopyAppendectomyNegative appendectomyMorbidity

Outcome Measures

Primary Outcomes (1)

  • Negative appendectomy

    Either a histologically proven normal appendix or in case of no appendectomy a 3 months disease free clinical course.

    3 months postoperatively

Secondary Outcomes (1)

  • Missed appendicitis

    3 months

Study Arms (1)

LAPP score

OTHER

Use of the LAPP score during a diagnostic laparoscopy.

Procedure: LAPP score

Interventions

LAPP scorePROCEDURE

Use of the LAPP score during a diagnostic laparoscopy.

LAPP score

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

NL(1)