Ruptured AppendicitisPhase 3RAPTORNCT00435032
Early Versus Interval Appendectomy for Ruptured Appendicitis in Children
A Phase 3 study testing early appendectomy and interval appendectomy in people with Ruptured Appendicitis, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Ruptured Appendicitis
- What is being tested?
- early appendectomy and interval appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of ruptured appendicitis
Who cannot join
- Inability to have usual follow up care (e.g. transient to area)
Trial locations and contacts
1 site in 1 country.
United States1 site
LeBonheur Children's Medical Center
Memphis, Tennessee, 38105
About this study
Official title: 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.
Read the 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.
- Conditions
- Ruptured Appendicitis
- Being tested
- early appendectomy, interval appendectomy
- Keywords
- ruptured appendicitis, children, surgery, randomized trial
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early appendectomyProcedure or surgery
Appendectomy within 24 hours of admission
interval appendectomyProcedure or surgery
Initial antibiotic treatment followed by appendectomy at 6-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Early appendectomy Receives: Procedure: early appendectomy |
| 2 | Active comparator | Interval appendectomy Receives: Procedure: interval appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time (days) away from normal activities (or time until returns to normal activities)
Measured: At completion of study
Secondary outcomes (14)
complication rates of each treatment arm:
Measured: At completion of study
Wound infection or dehiscence
Measured: Throughout study period
Intra-abdominal abscess
Measured: Throughout study period
Requires reoperation
Measured: Throughout study period
Bowel obstruction
Measured: Throughout study period
central venous catheter-related infection
Measured: Throughout study period
interventional radiology-related complication
Measured: Throughout study period
Total hospital length of stay
Measured: At study completion
# patients with central venous line
Measured: At study completion
# with interventional radiology drainage
Measured: At study completion
# of return visits to pediatrician, ED, surgery office
Measured: At study completion
Other complication
Measured: At study completion
quality of life questionnaire (SF10)
Measured: At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment
hospital costs
Measured: At study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ruptured AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Investigators
- Martin L Blakely, MD, Principal investigator, University of Tennessee Health Science Center, LeBonheur Children's Medical CenterBarbara Culbreath, RN, Study director, University of Tennessee Health Science Center, LeBonheur Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435032
- Sponsor's protocol ID
- R073223335
- Acronym
- RAPTOR
- Status last verified
- Jan 2010
- First submitted
- 12 Feb 2007
- Last updated
- 12 Jan 2010
- Results posted
- No
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.
PubMed 21339413
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)
- ClinicalTrials.gov ID
- NCT00435032
- Acronym / sponsor ID
- RAPTOR / R073223335
- Conditions
- Ruptured Appendicitis
- Keywords
- ruptured appendicitis, children, surgery, randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2009 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: early appendectomyEarly appendectomy |
| 2 | Active comparator | Procedure: interval appendectomyInterval appendectomy |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of ruptured appendicitis
Key exclusion criteria (1 listed)
- Inability to have usual follow up care (e.g. transient to area)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early appendectomyAppendectomy within 24 hours of admission | Procedure or surgery | 1 |
| interval appendectomyInitial antibiotic treatment followed by appendectomy at 6-8 weeks | Procedure or surgery | 2 |
Primary outcome
time (days) away from normal activities (or time until returns to normal activities)
Time frame: At completion of study
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Derived from this study: PubMed 21339413Blakely 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.
Related trials for Ruptured Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
Active, not recruiting
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Active, not recruitingPhase 2
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Perforated Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin L Blakely, MD principal investigator
University of Tennessee Health Science Center, LeBonheur Children's Medical Center
Barbara Culbreath, RN study director
University of Tennessee Health Science Center, LeBonheur Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing early appendectomy and interval appendectomy in people with Ruptured Appendicitis, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time (days) away from normal activities (or time until returns to normal activities) (time frame: At completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00435032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.