Acute AppendicitisNCT01348464
A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy
An observational study of Acute Appendicitis, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial Read more about this study
- Who is it for?
- Ages 5 to 85 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- single port appendectomy, three port appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Dec 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 5 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The cohorts will be the residents of Incheon, Korea
Who may be able to join
- age 5~85 years
- any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
- Patient performance status(PS) with greater than 80 or more on Karnofsky PS
- Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Who cannot join
- Pregnant or lactating
- Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study
The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial
Read the detailed description
- primary objective
- complication rate
- secondary objectives
- satisfaction rate
- pain scale difference
- Conditions
- Acute Appendicitis
- Being tested
- single port appendectomy, three port appendectomy
- Keywords
- appendectomy, appendicitis, laparoscopic surgery
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single port appendectomy, three port appendectomyProcedure or surgery
Also called Pain scale, Satisfactory score, complication rate
visual analog scale. questionnaire on wound satisfaction
| Study group | Role | What they receive |
|---|---|---|
| lifestyle, wound satisfaction | single site access three site access for appendectomy Receives: Procedure: single port appendectomy, three port appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
observe complication caused by both procedures
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 weeks
Secondary outcomes (1)
patient satisfaction
Questionarire is given to the patients on postoperative 3days, 1month, 3 months and 6 months
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMar 2010
- Study completionDec 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 Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-Suk Lee, Gachon University Gil Medical Center
- Investigators
- Won-Suk Lee, MD, Principal investigator, Gachon Univ. Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348464
- Sponsor's protocol ID
- girba2339
- Status last verified
- Apr 2012
- First submitted
- 29 Apr 2011
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Raakow R, Jacob DA. Initial experience in laparoscopic single-port appendectomy: a pilot study. Dig Surg. 2011;28(1):74-9. doi: 10.1159/000322921. Epub 2011 Feb 4.
PubMed 21293135
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT01348464
- Acronym / sponsor ID
- girba2339
- Conditions
- Acute Appendicitis
- Keywords
- appendectomy, appendicitis, laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Study completion
- Dec 2011 (actual)
- First posted
- 5 May 2011 (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 study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial
Detailed description
- primary objective
- complication rate
- secondary objectives
- satisfaction rate
- pain scale difference
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle, wound satisfaction | – | Procedure: single port appendectomy, three port appendectomysingle site access three site access for appendectomy |
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The cohorts will be the residents of Incheon, Korea
Key inclusion criteria (4 listed)
- age 5~85 years
- any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
- Patient performance status(PS) with greater than 80 or more on Karnofsky PS
- Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Key exclusion criteria (4 listed)
- Pregnant or lactating
- Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
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 |
|---|---|---|
| single port appendectomy, three port appendectomyAlso: Pain scale, Satisfactory score, complication ratevisual analog scale. questionnaire on wound satisfaction | Procedure or surgery | lifestyle, wound satisfaction |
Primary outcome
Complication rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks
observe complication caused by both procedures
1 secondary outcome
patient satisfaction
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks
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 4 Apr 2012.
- Background: PubMed 21293135Raakow R, Jacob DA. Initial experience in laparoscopic single-port appendectomy: a pilot study. Dig Surg. 2011;28(1):74-9. doi: 10.1159/000322921. Epub 2011 Feb 4.
- laparoscopic surgery teaching siteLink provided by the sponsor.
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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.
Won-Suk Lee, MD principal investigator
Gachon Univ. Gil Medical Center
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 Acute Appendicitis, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 4 inclusion and 4 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 4 Apr 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 South Korea. 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 rate (time frame: participants will be followed for the duration of hospital stay, an expected average of 24 weeks). 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 NCT01348464, 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 4 Apr 2012; AzTrials last refreshed its copy on 31 Oct 2026.