AppendicitisNCT00554008
Comparative Study of Laparoscopic Versus Open Appendectomy in Children
A study testing laparoscopic appendectomy and open appendectomy in people with Appendicitis, run by Oregon Health and Science University at 3 sites in United States.
Trial summary
The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- laparoscopic appendectomy and open appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2007to Jan 2011
- Phase
- Interventional
- 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
- All children under the age of 18 years with diagnosed appendicitis
Who cannot join
- Refusal of consent
- Primary language other than English or Spanish.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Los Angeles
Los Angeles, California, 90027
Emanuel Children's Hospital
Portland, Oregon, 97227
Oregon Health and Sciences University
Portland, Oregon, 97227
About this study
Official title: Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children
The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction.
The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.
- Conditions
- Appendicitis
- Being tested
- laparoscopic appendectomy, open appendectomy
- Keywords
- Appendicitis, laparoscopy, randomized trial, children, pediatric
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomyProcedure or surgery
appendix removal via scope
open appendectomyProcedure or surgery
open operation for removal of appendix
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | children randomized to open appendectomy Receives: Procedure: open appendectomy |
| 2 | Active comparator | children randomized to laparoscopic appendectomy Receives: Procedure: laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications, length of stay, pain medication requirements
Measured: within 30 days of intervention
Secondary outcomes (1)
Patient/family satisfaction
Measured: within 7 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, David Bliss, Oregon Health and Science University
- Investigators
- David Bliss, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554008
- Sponsor's protocol ID
- IRB00002184
- Status last verified
- May 2012
- First submitted
- 5 Nov 2007
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children
- ClinicalTrials.gov ID
- NCT00554008
- Acronym / sponsor ID
- IRB00002184
- Conditions
- Appendicitis
- Keywords
- Appendicitis, laparoscopy, randomized trial, children, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Nov 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 study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction.
The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: open appendectomychildren randomized to open appendectomy |
| 2 | Active comparator | Procedure: laparoscopic appendectomychildren randomized to laparoscopic appendectomy |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children under the age of 18 years with diagnosed appendicitis
Key exclusion criteria (2 listed)
- Refusal of consent
- Primary language other than English or Spanish.
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 |
|---|---|---|
| laparoscopic appendectomyappendix removal via scope | Procedure or surgery | 2 |
| open appendectomyopen operation for removal of appendix | Procedure or surgery | 1 |
Primary outcome
Surgical complications, length of stay, pain medication requirements
Time frame: within 30 days of intervention
1 secondary outcome
Patient/family satisfaction
Time frame: within 7 days of intervention
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 30 May 2012.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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.
David Bliss, M.D. principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic appendectomy and open appendectomy in people with Appendicitis, run by Oregon Health and Science University at 3 sites 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 2 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 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Surgical complications, length of stay, pain medication requirements (time frame: within 30 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2012.