NCT00435032

Brief Summary

The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

2.9 years

First QC Date

February 12, 2007

Last Update Submit

January 11, 2010

Conditions

Ruptured Appendicitis

Keywords

ruptured appendicitischildrensurgeryrandomized trial

Outcome Measures

Primary Outcomes (1)

  • time (days) away from normal activities (or time until returns to normal activities)

    At completion of study

Secondary Outcomes (14)

  • complication rates of each treatment arm:

    At completion of study

  • Wound infection or dehiscence

    Throughout study period

  • Intra-abdominal abscess

    Throughout study period

  • Requires reoperation

    Throughout study period

  • Bowel obstruction

    Throughout study period

  • +9 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Early appendectomy

Procedure: early appendectomy

2

ACTIVE COMPARATOR

Interval appendectomy

Procedure: interval appendectomy

Interventions

early appendectomyPROCEDURE

Appendectomy within 24 hours of admission

1
interval appendectomyPROCEDURE

Initial antibiotic treatment followed by appendectomy at 6-8 weeks

2

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of ruptured appendicitis

You may not qualify if:

  • Inability to have usual follow up care (e.g. transient to area)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LeBonheur Children's Medical Center

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Blakely ML, Williams R, Dassinger MS, Eubanks JW 3rd, Fischer P, Huang EY, Paton E, Culbreath B, Hester A, Streck C, Hixson SD, Langham MR Jr. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg. 2011 Jun;146(6):660-5. doi: 10.1001/archsurg.2011.6. Epub 2011 Feb 21.

    PMID: 21339413DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Martin L Blakely, MD

    University of Tennessee Health Science Center, LeBonheur Children's Medical Center

    PRINCIPAL INVESTIGATOR

  • Barbara Culbreath, RN

    University of Tennessee Health Science Center, LeBonheur Children's Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 14, 2007

Study Start

October 1, 2006

Primary Completion

September 1, 2009

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

US(1)