- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485247
Transumbilical Laparoscopy-assisted Appendectomy
August 31, 2020 updated by: Kyung-Goo Lee, Myongji Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kyung-Goo Lee, MD
- Phone Number: +82-31-810-5445
- Email: hashimot@naver.com
Study Locations
-
-
Gyeonggi-do
-
Goyang, Gyeonggi-do, Korea, Republic of, 412-826
- Recruiting
- Myongji Hospital, Hanyang University College of Medicine
-
Contact:
- Kyung-Goo Lee, MD
- Phone Number: +82-31-810-5445
- Email: hashimot@naver.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous abdominal operation
- Generalized peritonitis
- Anticipated extended resection
- Periappendiceal abscess on preoperative exam
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional group
conventional laparoscopic appendectomy with 3-ports
|
appendectomy performed intracorporeally with 3-port
|
Experimental: TULAA group
An operator extracts and ligates appendix through umbilical port.
|
appendectomy performed extracorporeally through umbilical port
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operation time
Time Frame: 1 day
|
Time from skin incision to skin closure
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complication rate
Time Frame: 1 month
|
Rate of 30 day complication or in-hospital complication
|
1 month
|
postoperative hospital stay
Time Frame: 1 month
|
postoperative hospital stay
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kyung-Goo Lee, MD, Myongji Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Dubbers 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.
- Shekherdimian 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2020
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 23, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Myongji Surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
all individual participant data that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
all individual participant data that underlie results in a publication
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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