Appendicitis AcuteNCT04485247
Transumbilical Laparoscopy-assisted Appendectomy
A study testing Transumbilical Laparoscopic-Assisted Appendectomy and 3-port laparoscopic appendectomy in people with Appendicitis Acute, run by Myongji Hospital at 1 site in South Korea.
Trial summary
transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective studies. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Transumbilical Laparoscopic-Assisted Appendectomy and 3-port laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2020to Mar 2022
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with clinically diagnosed as acute appendicitis
- Age 18 or under
- Lab tests Hemoglobin ≥ 10g/dl White blood cell count ≥ 4,000/mm3 Platelet count ≥ 100,000/mm3 Creatinine ≤ 1.5 mg/dl Aspartate aminotransferase ≤ 100 IU/L Alanine aminotransferase ≤ 100 IU/L
- no significant dysfunction in the heart, lungs, kidneys.
Who cannot join
- Previous abdominal operation
- Generalized peritonitis
- Anticipated extended resection
- Periappendiceal abscess on preoperative exam
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Myongji Hospital, Hanyang university college of medicine
Goyang-si, Gyeonggi-do, 412-826
Kyung-Goo Lee, MD, +82-31-810-5445, hashimot@naver.com
About this study
Official title: Is Transumbilical Laparoscopy-assisted Appendectomy in the Pediatric Acute Uncomplicated Appendicitis Superior to Conventional 3 Port Laparoscopic Appendectomy?
transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective studies. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.
Read the detailed description
Single port appendectomy can be considered as the better option than conventional laparoscopic appendectomy (CLA) for pediatric patients with uncomplicated acute appendicitis in cosmetic aspect. However, this technique has not gained popularity because it has been regarded as a tricky and time-consuming procedure. Recently, the frequency of implementation of transumbilical laparoscopy-assisted appendectomy (TULAA) is increasing in pediatric patients with uncomplicated appendicitis. The reason that this operation is possible in children, is that the length between umbilicus and appendix is shorter than that of an adult, and the abdominal wall is flexible, so that the appendix can be extracted through umbilical incision. It was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to the laparoscopic appendectomy with three conventional ports. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.
- Conditions
- Appendicitis Acute
- Being tested
- Transumbilical Laparoscopic-Assisted Appendectomy, 3-port laparoscopic appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transumbilical Laparoscopic-Assisted AppendectomyProcedure or surgery
appendectomy performed extracorporeally through umbilical port
3-port laparoscopic appendectomyProcedure or surgery
appendectomy performed intracorporeally with 3-port
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | conventional laparoscopic appendectomy with 3-ports Receives: Procedure: 3-port laparoscopic appendectomy |
| TULAA group | Experimental | An operator extracts and ligates appendix through umbilical port. Receives: Procedure: Transumbilical Laparoscopic-Assisted Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Time from skin incision to skin closure
Measured: 1 day
Secondary outcomes (2)
Postoperative complication rate
Rate of 30 day complication or in-hospital complication
Measured: 1 month
postoperative hospital stay
postoperative hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start3 Aug 2020
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung-Goo Lee, Myongji Hospital
- Investigators
- Kyung-Goo Lee, MD, Principal investigator, Myongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485247
- Sponsor's protocol ID
- Myongji Surgery
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie results in a publication
Publications
Sekioka A, Takahashi T, Yamoto M, Miyake H, Fukumoto K, Nakaya K, Nomura A, Yamada Y, Urushihara N. Outcomes of Transumbilical Laparoscopic-Assisted Appendectomy and Conventional Laparoscopic Appendectomy for Acute Pediatric Appendicitis in a Single Institution. J Laparoendosc Adv Surg Tech A. 2018 Dec;28(12):1548-1552. doi: 10.1089/lap.2018.0306. Epub 2018 Aug 8.
PubMed 30088968Dubbers M, Nikolaou E, Fuchs H, Fischer J, Alakus H, Leers J, Bruns C, Cernaianu G. Update on Transumbilical Single-Incision Laparoscopic Assisted Appendectomy (TULAA) - Which Children Benefit and What are the Complications? Klin Padiatr. 2018 Jul;230(4):194-199. doi: 10.1055/s-0044-101622. Epub 2018 Mar 15.
PubMed 29544230Shekherdimian S, DeUgarte D. Transumbilical laparoscopic-assisted appendectomy: an extracorporeal single-incision alternative to conventional laparoscopic techniques. Am Surg. 2011 May;77(5):557-60. doi: 10.1177/000313481107700513.
PubMed 21679587
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Transumbilical Laparoscopy-assisted Appendectomy in the Pediatric Acute Uncomplicated Appendicitis Superior to Conventional 3 Port Laparoscopic Appendectomy?
- ClinicalTrials.gov ID
- NCT04485247
- Acronym / sponsor ID
- Myongji Surgery
- Conditions
- Appendicitis Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Myongji HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 24 Jul 2020 (actual)
- 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.
transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective studies. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.
Detailed description
Single port appendectomy can be considered as the better option than conventional laparoscopic appendectomy (CLA) for pediatric patients with uncomplicated acute appendicitis in cosmetic aspect. However, this technique has not gained popularity because it has been regarded as a tricky and time-consuming procedure. Recently, the frequency of implementation of transumbilical laparoscopy-assisted appendectomy (TULAA) is increasing in pediatric patients with uncomplicated appendicitis. The reason that this operation is possible in children, is that the length between umbilicus and appendix is shorter than that of an adult, and the abdominal wall is flexible, so that the appendix can be extracted through umbilical incision. It was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to the laparoscopic appendectomy with three conventional ports. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Procedure: 3-port laparoscopic appendectomyconventional laparoscopic appendectomy with 3-ports |
| TULAA group | Experimental | Procedure: Transumbilical Laparoscopic-Assisted AppendectomyAn operator extracts and ligates appendix through umbilical port. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with clinically diagnosed as acute appendicitis
- Age 18 or under
- Lab tests Hemoglobin ≥ 10g/dl White blood cell count ≥ 4,000/mm3 Platelet count ≥ 100,000/mm3 Creatinine ≤ 1.5 mg/dl Aspartate aminotransferase ≤ 100 IU/L Alanine aminotransferase ≤ 100 IU/L
- no significant dysfunction in the heart, lungs, kidneys.
Key exclusion criteria (4 listed)
- Previous abdominal operation
- Generalized peritonitis
- Anticipated extended resection
- Periappendiceal abscess on preoperative exam
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 |
|---|---|---|
| Transumbilical Laparoscopic-Assisted Appendectomyappendectomy performed extracorporeally through umbilical port | Procedure or surgery | TULAA group |
| 3-port laparoscopic appendectomyappendectomy performed intracorporeally with 3-port | Procedure or surgery | Conventional group |
Primary outcome
Operation time
Time frame: 1 day
Time from skin incision to skin closure
2 secondary outcomes
Postoperative complication rate
Time frame: 1 month
postoperative hospital stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 30088968Sekioka A, Takahashi T, Yamoto M, Miyake H, Fukumoto K, Nakaya K, Nomura A, Yamada Y, Urushihara N. Outcomes of Transumbilical Laparoscopic-Assisted Appendectomy and Conventional Laparoscopic Appendectomy for Acute Pediatric Appendicitis in a Single Institution. J Laparoendosc Adv Surg Tech A. 2018 Dec;28(12):1548-1552. doi: 10.1089/lap.2018.0306. Epub 2018 Aug 8.
- Results publication: PubMed 29544230Dubbers M, Nikolaou E, Fuchs H, Fischer J, Alakus H, Leers J, Bruns C, Cernaianu G. Update on Transumbilical Single-Incision Laparoscopic Assisted Appendectomy (TULAA) - Which Children Benefit and What are the Complications? Klin Padiatr. 2018 Jul;230(4):194-199. doi: 10.1055/s-0044-101622. Epub 2018 Mar 15.
- Results publication: PubMed 21679587Shekherdimian S, DeUgarte D. Transumbilical laparoscopic-assisted appendectomy: an extracorporeal single-incision alternative to conventional laparoscopic techniques. Am Surg. 2011 May;77(5):557-60. doi: 10.1177/000313481107700513.
- Individual participant dataSharing planned: Yes. all individual participant data that underlie results in a publication
Related trials for Appendicitis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Active, not recruitingObservational study
Retrospective Acute Care Appendectomy Study
Acute Appendicitis
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute 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.
Kyung-Goo Lee, MD principal investigator
Myongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transumbilical Laparoscopic-Assisted Appendectomy and 3-port laparoscopic appendectomy in people with Appendicitis Acute, run by Myongji Hospital 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Goo Lee, MD (+82-31-810-5445, hashimot@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: 1 day). 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 NCT04485247, which also lists 3 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 2 Sep 2020.