AppendicitisPhase 1NCT00816933
Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
A Phase 1 study testing appendectomy in people with Appendicitis and Pain, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Appendicitis is the most common benign inflammatory disease that requires an operation. Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. Read more about this study
- Who is it for?
- Ages 8 to 75 years
- Conditions the study is for
- Appendicitis, Pain, Complications
- What is being tested?
- appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jan 2010
- Phase
- Phase 1
- 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 8 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Appendicitis (clinical or radilogical diagnosis)
- ASA < 4
Who cannot join
- Appendicitis with palpable mass( clinical or radilogical diagnosis)
- Patient has bleeding tendency
- Pregnant
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dept. of Surgery, Holy Family Hospital, College of Medicine, The Catholic University of Korea
Bucheon-si, Gyunggi Do, 420-717
Wook Kim, professor, +82-32-340-7022, kimwook@catholic.ac.kr
Junhyun Lee, Instructor, +82-32-340-7026, surgeryjun@catholic.ac.kr
About this study
Official title: Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
Appendicitis is the most common benign inflammatory disease that requires an operation.
Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.
- Conditions
- Appendicitis, Pain, Complications
- Being tested
- appendectomy
- Keywords
- pain, operative times, complication, time to return for normal life, pain using VAS score
- Medical subject headings
- Appendicitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendectomyProcedure or surgery
appendectomy according to the number of trocar
| Study group | Role | What they receive |
|---|---|---|
| one port | Experimental | Patients undergo one port appectomy. Skin incision about 2cm size is made upon umbilicus and dissection is performed to make opening. Then, wound retractcor(Alexis) is iserted on opening site and wound is extended. Rubber glove built-in three 5mm trocars is applied over wound retractor. Pneumoperitoneum is achieved via trocar and appendectomy is performed. After appendectomy, wound is repaired. Receives: Procedure: appendectomy |
| Three ports | Active comparator | Paitents will undergo three port appendectomy. 10 mm trocar is inserted on umbilicus, and two 5mm trocas is inserted low abdomen, left flank respectively.
Appendectomy is performed vis these trocas. After operation, wounds are repaired. Receives: Procedure: appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
Measured: For 7days
Secondary outcomes (1)
cosmetic effect
Measured: for 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816933
- Sponsor's protocol ID
- HFHAPPE 01
- Status last verified
- Jan 2009
- First submitted
- 2 Jan 2009
- Last updated
- 6 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kye BH, Lee J, Kim W, Kim D, Lee D. Comparative study between single-incision and three-port laparoscopic appendectomy: a prospective randomized trial. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):431-6. doi: 10.1089/lap.2012.0284. Epub 2013 Mar 8.
PubMed 23473061Lee J, Baek J, Kim W. Laparoscopic transumbilical single-port appendectomy: initial experience and comparison with three-port appendectomy. Surg Laparosc Endosc Percutan Tech. 2010 Apr;20(2):100-3. doi: 10.1097/SLE.0b013e3181d84922.
PubMed 20393336
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT00816933
- Acronym / sponsor ID
- HFHAPPE 01
- Conditions
- Appendicitis, Pain, Complications
- Keywords
- pain, operative times, complication, time to return for normal life, pain using VAS score
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 5 Jan 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.
Appendicitis is the most common benign inflammatory disease that requires an operation.
Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one port | Experimental | Procedure: appendectomyPatients undergo one port appectomy. Skin incision about 2cm size is made upon umbilicus and dissection is performed to make opening. Then, wound retractcor(Alexis) is iserted on opening site and wound is extended. Rubber glove built-in three 5mm trocars is applied over wound retractor. Pneumoperitoneum is achieved via trocar and appendectomy is performed. After appendectomy, wound is repaired. |
| Three ports | Active comparator | Procedure: appendectomyPaitents will undergo three port appendectomy. 10 mm trocar is inserted on umbilicus, and two 5mm trocas is inserted low abdomen, left flank respectively. Appendectomy is performed vis these trocas. After operation, wounds are repaired. |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Appendicitis (clinical or radilogical diagnosis)
- ASA < 4
Key exclusion criteria (3 listed)
- Appendicitis with palpable mass( clinical or radilogical diagnosis)
- Patient has bleeding tendency
- Pregnant
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 |
|---|---|---|
| appendectomyappendectomy according to the number of trocar | Procedure or surgery | Three ports, one port |
Primary outcome
post-operative pain
Time frame: For 7days
1 secondary outcome
cosmetic effect
Time frame: for 14days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2009.
- Derived from this study: PubMed 23473061Kye BH, Lee J, Kim W, Kim D, Lee D. Comparative study between single-incision and three-port laparoscopic appendectomy: a prospective randomized trial. J Laparoendosc Adv Surg Tech A. 2013 May;23(5):431-6. doi: 10.1089/lap.2012.0284. Epub 2013 Mar 8.
- Derived from this study: PubMed 20393336Lee J, Baek J, Kim W. Laparoscopic transumbilical single-port appendectomy: initial experience and comparison with three-port appendectomy. Surg Laparosc Endosc Percutan Tech. 2010 Apr;20(2):100-3. doi: 10.1097/SLE.0b013e3181d84922.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing appendectomy in people with Appendicitis and Pain, run by The Catholic University of Korea 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Jan 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wook Kim, professor (+82-32-340-7022, kimwook@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: For 7days). 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 NCT00816933, which also lists 2 linked publications.
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 Jan 2009.