Intraabdominal AbscessNCT01657565
Appendectomy in Children Performed by Residents in the Era of Laparoscopic Surgery
An observational study of Intraabdominal Abscess and Wound Infection, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic appendectomy (LA). The investigators wanted to elucidate the outcome of childhood appendicitis treated primarily by residents in a university hospital. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Intraabdominal Abscess, Wound Infection
- How many people
- 390 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jan 2011
- Phase
- Observational
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children 0-15 years of age having an appendectomy
Who may be able to join
- age below 16 years. operated on suspicion of appendicitis
Who cannot join
- appendectomy for causes other than suspicion of appendicitis
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic appendectomy (LA). The investigators wanted to elucidate the outcome of childhood appendicitis treated primarily by residents in a university hospital.
Material and methods: All children (age<16 years) treated surgically with appendectomy in our department between January 2006 and January 2011 were retrospectively identified. Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were considered as non-satisfactory outcomes.
- Conditions
- Intraabdominal Abscess, Wound Infection
- Keywords
- LOS, Ileus, Fever, reoperation
- Medical subject headings
- Wound Infection, Ileus, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| open appendectomy | Not described | |
| laparscopic appendectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJan 2006
- Primary completionJan 2011
- Study completionJan 2011
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 Intraabdominal AbscessStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolaj Markus Stilling, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657565
- Sponsor's protocol ID
- ED209
- Other IDs
- Appendectomy in children
- Status last verified
- Aug 2012
- First submitted
- 2 Aug 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stilling NM, Fristrup C, Gabers T, Qvist N, Rasmussen L. Acceptable outcome after laparoscopic appendectomy in children. Dan Med J. 2013 Jan;60(1):A4564.
PubMed 23340188
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appendectomy in Children Performed by Residents in the Era of Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01657565
- Acronym / sponsor ID
- ED209
- Conditions
- Intraabdominal Abscess, Wound Infection
- Keywords
- LOS, Ileus, Fever, reoperation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Aug 2012 (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.
Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic appendectomy (LA). The investigators wanted to elucidate the outcome of childhood appendicitis treated primarily by residents in a university hospital.
Material and methods: All children (age<16 years) treated surgically with appendectomy in our department between January 2006 and January 2011 were retrospectively identified. Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were considered as non-satisfactory outcomes.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open appendectomy | – | – |
| laparscopic appendectomy | – | – |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children 0-15 years of age having an appendectomy
Key inclusion criteria (1 listed)
- age below 16 years. operated on suspicion of appendicitis
Key exclusion criteria (1 listed)
- appendectomy for causes other than suspicion of appendicitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical complications
Time frame: 30 days
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 6 Aug 2012.
- Derived from this study: PubMed 23340188Stilling NM, Fristrup C, Gabers T, Qvist N, Rasmussen L. Acceptable outcome after laparoscopic appendectomy in children. Dan Med J. 2013 Jan;60(1):A4564.
Related trials for Intraabdominal Abscess
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute Appendicitis
RecruitingObservational study
Re-assessment of Appendicitis Evaluation During Laparoscopic Appendectomy, Peritoneal Irrigation During Laparoscopic Appendectomy Does the Grade of Contamination Matter?
Appendicitis, Appendectomy
RecruitingPhase 4
APPI-Cost Trial for Perforated Appendicitis
Perforated Appendicitis
Recruiting
Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Abscess and Wound Infection, run by Odense University Hospital at 1 site in Denmark.
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 6 Aug 2012. 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 Denmark. 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 (time frame: 30 days). 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 NCT01657565, 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 6 Aug 2012.