Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

NCT ID: NCT00435032

Last Updated: 2010-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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.

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.

Conditions

Ruptured Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Early appendectomy

Group Type: ACTIVE_COMPARATOR

early appendectomy

Intervention Type: PROCEDURE

Appendectomy within 24 hours of admission

2

Interval appendectomy

Group Type: ACTIVE_COMPARATOR

interval appendectomy

Intervention Type: PROCEDURE

Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Interventions

early appendectomy

Appendectomy within 24 hours of admission

Intervention Type: PROCEDURE

interval appendectomy

Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of ruptured appendicitis

Exclusion Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

University of Tennessee

Principal Investigators

Martin L Blakely, MD

Role: PRINCIPAL_INVESTIGATOR

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

Barbara Culbreath, RN

Role: STUDY_DIRECTOR

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

Locations

LeBonheur Children's Medical Center

Memphis, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21339413 (View on PubMed)

Other Identifiers

R073223335

Identifier Type: -

Identifier Source: org_study_id