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Early Versus Interval Appendectomy for Ruptured Appendicitis in Children (RAPTOR)

Primary Purpose

Ruptured Appendicitis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

early appendectomy

interval appendectomy

About this trial

This is an interventional treatment trial for Ruptured Appendicitis focused on measuring ruptured appendicitis, children, surgery, randomized trial

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

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

Sites / Locations

LeBonheur Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Early appendectomy

Interval appendectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

complication rates of each treatment arm:

Wound infection or dehiscence

Intra-abdominal abscess

Requires reoperation

Bowel obstruction

central venous catheter-related infection

interventional radiology-related complication

Total hospital length of stay

# patients with central venous line

# with interventional radiology drainage

# of return visits to pediatrician, ED, surgery office

Other complication

quality of life questionnaire (SF10)

hospital costs

Full Information

NCT ID

NCT00435032

First Posted

February 12, 2007

Last Updated

January 11, 2010

Sponsor

University of Tennessee

1. Study Identification

Unique Protocol Identification Number

NCT00435032

Brief Title

Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

Acronym

RAPTOR

Official Title

Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Tennessee

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ruptured Appendicitis

Keywords

ruptured appendicitis, children, surgery, randomized trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Early appendectomy

Arm Title

Arm Type

Active Comparator

Arm Description

Interval appendectomy

Intervention Type

Procedure

Intervention Name(s)

early appendectomy

Intervention Description

Appendectomy within 24 hours of admission

Intervention Type

Procedure

Intervention Name(s)

interval appendectomy

Intervention Description

Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

At completion of study

Secondary Outcome Measure Information:

Title

complication rates of each treatment arm:

Time Frame

At completion of study

Title

Wound infection or dehiscence

Time Frame

Throughout study period

Title

Intra-abdominal abscess

Time Frame

Throughout study period

Title

Requires reoperation

Time Frame

Throughout study period

Title

Bowel obstruction

Time Frame

Throughout study period

Title

central venous catheter-related infection

Time Frame

Throughout study period

Title

interventional radiology-related complication

Time Frame

Throughout study period

Title

Total hospital length of stay

Time Frame

At study completion

Title

# patients with central venous line

Time Frame

At study completion

Title

# with interventional radiology drainage

Time Frame

At study completion

Title

# of return visits to pediatrician, ED, surgery office

Time Frame

At study completion

Title

Other complication

Time Frame

At study completion

Title

quality of life questionnaire (SF10)

Time Frame

At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment

Title

hospital costs

Time Frame

At study completion

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of ruptured appendicitis Exclusion Criteria: Inability to have usual follow up care (e.g. transient to area)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin L Blakely, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Barbara Culbreath, RN

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

LeBonheur Children's Medical Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21339413

Citation

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.

Results Reference

derived

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Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

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