AppendicitisNCT00908804
Open Versus Laparoscopic Appendectomy
A study testing open appendectomy and laparoscopic appendectomy in people with Appendicitis, run by North Karelia Central Hospital at 1 site in Finland.
Trial summary
The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- open appendectomy and laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Start not givento not given
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age over 15 years
- suspected acute appendicitis
- suitability for laparoscopy
Who cannot join
- patients refusal to participate
- lack of a laparoscopic surgeon
Trial locations and contacts
1 site in 1 country.
Finland1 site
North Karelia Central Hospital, Clinic of Surgery
Joensuu, 80210
About this study
Official title: Open Versus Laparoscopic Appendectomy in Suspected Acute Appendicitis - a Prospective Randomised Clinical Trial With With 10-Year Follow-up
The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.
- Conditions
- Appendicitis
- Being tested
- open appendectomy, laparoscopic appendectomy
- Keywords
- acute appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open appendectomyProcedure or surgery
laparoscopic appendectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| open appendectomy | Active comparator | Not described Receives: Procedure: open appendectomy |
| laparoscopic appendectomy | Active comparator | Not described Receives: Procedure: laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication; wound problem or other primary complication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
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 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 N/A
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908804
- Sponsor's protocol ID
- NKCH-surg-004
- Status last verified
- May 2009
- First submitted
- 26 May 2009
- Last updated
- 27 May 2009
- Results posted
- No
Publications
Kouhia ST, Heiskanen JT, Huttunen R, Ahtola HI, Kiviniemi VV, Hakala T. Long-term follow-up of a randomized clinical trial of open versus laparoscopic appendicectomy. Br J Surg. 2010 Sep;97(9):1395-400. doi: 10.1002/bjs.7114.
PubMed 20632312
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Laparoscopic Appendectomy in Suspected Acute Appendicitis - a Prospective Randomised Clinical Trial With With 10-Year Follow-up
- ClinicalTrials.gov ID
- NCT00908804
- Acronym / sponsor ID
- NKCH-surg-004
- Conditions
- Appendicitis
- Keywords
- acute appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- First posted
- 27 May 2009 (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 aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open appendectomy | Active comparator | Procedure: open appendectomy |
| laparoscopic appendectomy | Active comparator | Procedure: laparoscopic appendectomy |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age over 15 years
- suspected acute appendicitis
- suitability for laparoscopy
Key exclusion criteria (2 listed)
- patients refusal to participate
- lack of a laparoscopic surgeon
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 |
|---|---|---|
| open appendectomy | Procedure or surgery | open appendectomy |
| laparoscopic appendectomy | Procedure or surgery | laparoscopic appendectomy |
Primary outcome
Complication; wound problem or other primary complication
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 27 May 2009.
- Derived from this study: PubMed 20632312Kouhia ST, Heiskanen JT, Huttunen R, Ahtola HI, Kiviniemi VV, Hakala T. Long-term follow-up of a randomized clinical trial of open versus laparoscopic appendicectomy. Br J Surg. 2010 Sep;97(9):1395-400. doi: 10.1002/bjs.7114.
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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?
A study testing open appendectomy and laparoscopic appendectomy in people with Appendicitis, run by North Karelia Central Hospital at 1 site in Finland.
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 3 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 27 May 2009. 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 Finland. 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?
Complication; wound problem or other primary complication. 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 NCT00908804, 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 27 May 2009.