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

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

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.

Study Overview

• Status: Completed
• Conditions: Ruptured Appendicitis
• Intervention / Treatment: Procedure: early appendectomy; Procedure: interval appendectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Early appendectomy	Procedure: early appendectomy; Appendectomy within 24 hours of admission
Active Comparator: 2; Interval appendectomy	Procedure: interval appendectomy; Initial antibiotic treatment followed by appendectomy at 6-8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time (days) away from normal activities (or time until returns to normal activities)	At completion of study

Secondary Outcome Measures

Outcome Measure	Time Frame
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
central venous catheter-related infection	Throughout study period
interventional radiology-related complication	Throughout study period
Total hospital length of stay	At study completion
# patients with central venous line	At study completion
# with interventional radiology drainage	At study completion
# of return visits to pediatrician, ED, surgery office	At study completion
Other complication	At study completion
quality of life questionnaire (SF10)	At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment
hospital costs	At study completion

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: February 12, 2007
• First Submitted That Met QC Criteria: February 13, 2007
• First Posted (Estimate): February 14, 2007

Study Record Updates

• Last Update Posted (Estimate): January 12, 2010
• Last Update Submitted That Met QC Criteria: January 11, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: randomized trial; surgery; children; ruptured appendicitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: R073223335