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Completed

NCT Number: NCT00435032

Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

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.

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Key information

Conditions

Ruptured Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LeBonheur Children's Medical Center

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of ruptured appendicitis

Exclusion criteria

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

Treatment and study plan

early appendectomy

Procedure

Appendectomy within 24 hours of admission

interval appendectomy

Procedure

Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Primary outcomes

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

    Time frame: At completion of study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

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

Acronym: RAPTOR

Important dates

Study start
2006
Primary completion
2009
First posted
Feb 14, 2007
Registry last updated
Jan 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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