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

• ClinicalTrials.gov Identifier: NCT00435032
• Recruitment Status: Completed
• First Posted: February 14, 2007
• Last Update Posted: January 12, 2010
• Sponsor: University of Tennessee
• Information provided by: University of Tennessee

Tracking Information

• First Submitted Date: February 12, 2007
• First Posted Date: February 14, 2007
• Last Update Posted Date: January 12, 2010
• Study Start Date: October 2006
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: February 13, 2007): time (days) away from normal activities (or time until returns to normal activities)

Current Secondary Outcome Measures (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 (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: Early Versus Interval Appendectomy for Ruptured Appendicitis in Children
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ruptured Appendicitis

Intervention

• Procedure: early appendectomy
  Appendectomy within 24 hours of admission
• Procedure: interval appendectomy
  Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: February 13, 2007): 128
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00435032
• Other Study ID Numbers: R073223335
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Martin Blakely, University of Tennessee
• Study Sponsor: University of Tennessee
• Collaborators: Not Provided

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

• PRS Account: University of Tennessee
• Verification Date: January 2010