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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00435032
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
University of Tennessee

Tracking Information
First Submitted Date  ICMJE February 12, 2007
First Posted Date  ICMJE February 14, 2007
Last Update Posted Date January 12, 2010
Study Start Date  ICMJE October 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2009)
time (days) away from normal activities (or time until returns to normal activities) [ Time Frame: At completion of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2007)
time (days) away from normal activities (or time until returns to normal activities)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2009)
  • complication rates of each treatment arm: [ Time Frame: At completion of study ]
  • Wound infection or dehiscence [ Time Frame: Throughout study period ]
  • Intra-abdominal abscess [ Time Frame: Throughout study period ]
  • Requires reoperation [ Time Frame: Throughout study period ]
  • Bowel obstruction [ Time Frame: Throughout study period ]
  • central venous catheter-related infection [ Time Frame: Throughout study period ]
  • interventional radiology-related complication [ Time Frame: Throughout study period ]
  • Total hospital length of stay [ Time Frame: At study completion ]
  • # patients with central venous line [ Time Frame: At study completion ]
  • # with interventional radiology drainage [ Time Frame: At study completion ]
  • # of return visits to pediatrician, ED, surgery office [ Time Frame: At study completion ]
  • Other complication [ Time Frame: At study completion ]
  • quality of life questionnaire (SF10) [ Time Frame: At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment ]
  • hospital costs [ Time Frame: At study completion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2007)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Versus Interval Appendectomy for Ruptured Appendicitis in Children
Official Title  ICMJE Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ruptured Appendicitis
Intervention  ICMJE
  • Procedure: early appendectomy
    Appendectomy within 24 hours of admission
  • Procedure: interval appendectomy
    Initial antibiotic treatment followed by appendectomy at 6-8 weeks
Study Arms  ICMJE
  • Active Comparator: 1
    Early appendectomy
    Intervention: Procedure: early appendectomy
  • Active Comparator: 2
    Interval appendectomy
    Intervention: Procedure: interval appendectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 13, 2007)
128
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

  • Inability to have usual follow up care (e.g. transient to area)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00435032
Other Study ID Numbers  ICMJE R073223335
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Blakely, University of Tennessee
Study Sponsor  ICMJE University of Tennessee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Tennessee
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP