NCT00414375

Brief Summary

The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess. The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 3, 2009

Status Verified

March 1, 2009

Enrollment Period

2.2 years

First QC Date

December 19, 2006

Last Update Submit

March 2, 2009

Conditions

Appendiceal Abscess

Keywords

Perforated AppendicitisAbscessAppendectomy

Outcome Measures

Primary Outcomes (1)

  • Pilot

    3 months

Secondary Outcomes (1)

  • PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drainage with interval appendectomy

Procedure: Drainage and Interval Appendectomy

2

EXPERIMENTAL

appendectomy on presentation

Procedure: Operation on Admission

Interventions

Operation on AdmissionPROCEDURE

Laparoscopic appendectomy on admission

2
Drainage and Interval AppendectomyPROCEDURE

drainage with interval appendectomy

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
  • Children of any age will be included.

You may not qualify if:

  • Patients with immune deficiency
  • Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
  • Acute sepsis or severe pain from perforation not allowing for delayed management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

AppendicitisAbscess

Interventions

Drainage

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesSuppurationInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

March 3, 2009

Record last verified: 2009-03

Locations

US(1)