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

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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

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.

Condition or disease Intervention/treatment Phase
Ruptured Appendicitis Procedure: early appendectomy Procedure: interval appendectomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)
Study Start Date : October 2006
Actual Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis Tears

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




Primary Outcome Measures :
  1. time (days) away from normal activities (or time until returns to normal activities) [ Time Frame: At completion of study ]

Secondary Outcome Measures :
  1. complication rates of each treatment arm: [ Time Frame: At completion of study ]
  2. Wound infection or dehiscence [ Time Frame: Throughout study period ]
  3. Intra-abdominal abscess [ Time Frame: Throughout study period ]
  4. Requires reoperation [ Time Frame: Throughout study period ]
  5. Bowel obstruction [ Time Frame: Throughout study period ]
  6. central venous catheter-related infection [ Time Frame: Throughout study period ]
  7. interventional radiology-related complication [ Time Frame: Throughout study period ]
  8. Total hospital length of stay [ Time Frame: At study completion ]
  9. # patients with central venous line [ Time Frame: At study completion ]
  10. # with interventional radiology drainage [ Time Frame: At study completion ]
  11. # of return visits to pediatrician, ED, surgery office [ Time Frame: At study completion ]
  12. Other complication [ Time Frame: At study completion ]
  13. quality of life questionnaire (SF10) [ Time Frame: At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment ]
  14. hospital costs [ Time Frame: At study completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435032


Locations
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United States, Tennessee
LeBonheur Children's Medical Center
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
University of Tennessee
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martin Blakely, University of Tennessee
ClinicalTrials.gov Identifier: NCT00435032     History of Changes
Other Study ID Numbers: R073223335
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010
Keywords provided by University of Tennessee:
ruptured appendicitis
children
surgery
randomized trial
Additional relevant MeSH terms:
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Appendicitis
Rupture
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Wounds and Injuries