Early Versus Interval Appendectomy for Ruptured Appendicitis in Children - Full Text View

Sponsor:	University of Tennessee
Information provided by:	University of Tennessee
ClinicalTrials.gov Identifier:	NCT00435032

Purpose

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.

Condition	Intervention	Phase
Ruptured Appendicitis	Procedure: early appendectomy Procedure: interval appendectomy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis Surgery

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:

time (days) away from normal activities (or time until returns to normal activities) [ Time Frame: At completion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

complication rates of each treatment arm: [ Time Frame: At completion of study ] [ Designated as safety issue: No ]
Wound infection or dehiscence [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
Intra-abdominal abscess [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
Requires reoperation [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
Bowel obstruction [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
central venous catheter-related infection [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
interventional radiology-related complication [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
Total hospital length of stay [ Time Frame: At study completion ] [ Designated as safety issue: No ]
# patients with central venous line [ Time Frame: At study completion ] [ Designated as safety issue: No ]
# with interventional radiology drainage [ Time Frame: At study completion ] [ Designated as safety issue: No ]
# of return visits to pediatrician, ED, surgery office [ Time Frame: At study completion ] [ Designated as safety issue: No ]
Other complication [ Time Frame: At study completion ] [ Designated as safety issue: No ]
quality of life questionnaire (SF10) [ Time Frame: At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment ] [ Designated as safety issue: No ]
hospital costs [ Time Frame: At study completion ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	October 2006
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Early appendectomy	Procedure: early appendectomy Appendectomy within 24 hours of admission
2: Active Comparator Interval appendectomy	Procedure: interval appendectomy Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Detailed Description:

There are two surgical treatment options for children with ruptured appendicitis. Early appendectomy is one option and typically involves removing the ruptured appendix after several hours of optimizing the patient medically with intravenous fluids and intravenous antibiotics. Another option, interval appendectomy, uses the same initial fluid and antibiotic management, but delays removing the appendix until 6-8 weeks later. The rationale for delaying the appendectomy is to perform the operation at a time when the patient is perhaps more stable and the abdominal cavity is free from contamination. Both of these treatment options are currently used by many pediatric surgeons across the United States and both appear to work well. The two treatment have never been compared in any prospective study. The primary outcome of the study is the time that a patient (and family) is away from normal activities, due to the disease and its treatment. Secondary outcome measures include complication rates, quality of life measures (SF10), hospital cost analysis, and others.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435032

Locations

United States, Tennessee
LeBonheur Children's Medical Center
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

University of Tennessee

Investigators

Principal Investigator:	Martin L Blakely, MD	University of Tennessee Health Science Center, LeBonheur Children's Medical Center
Study Director:	Barbara Culbreath, RN	University of Tennessee Health Science Center, LeBonheur Children's Medical Center

More Information

No publications provided

Responsible Party:	University of Tennessee ( Martin Blakely )
Study ID Numbers:	R073223335
Study First Received:	February 12, 2007
Last Updated:	January 11, 2010
ClinicalTrials.gov Identifier:	NCT00435032 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Tennessee:

ruptured appendicitis
children
surgery
randomized trial

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Appendicitis
Wounds and Injuries
Disorders of Environmental Origin

Rupture
Intestinal Diseases
Gastroenteritis
Cecal Diseases

ClinicalTrials.gov processed this record on February 08, 2010