Transumbilical Laparoscopy-assisted Appendectomy
Primary Purpose
Appendicitis Acute
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transumbilical Laparoscopic-Assisted Appendectomy
3-port laparoscopic appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis Acute
Eligibility Criteria
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
Sites / Locations
- Myongji Hospital, Hanyang university college of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional group
TULAA group
Arm Description
conventional laparoscopic appendectomy with 3-ports
An operator extracts and ligates appendix through umbilical port.
Outcomes
Primary Outcome Measures
Operation time
Time from skin incision to skin closure
Secondary Outcome Measures
Postoperative complication rate
Rate of 30 day complication or in-hospital complication
postoperative hospital stay
postoperative hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04485247
Brief Title
Transumbilical Laparoscopy-assisted Appendectomy
Official Title
Is Transumbilical Laparoscopy-assisted Appendectomy in the Pediatric Acute Uncomplicated Appendicitis Superior to Conventional 3 Port Laparoscopic Appendectomy?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Myongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
conventional laparoscopic appendectomy with 3-ports
Arm Title
TULAA group
Arm Type
Experimental
Arm Description
An operator extracts and ligates appendix through umbilical port.
Intervention Type
Procedure
Intervention Name(s)
Transumbilical Laparoscopic-Assisted Appendectomy
Intervention Description
appendectomy performed extracorporeally through umbilical port
Intervention Type
Procedure
Intervention Name(s)
3-port laparoscopic appendectomy
Intervention Description
appendectomy performed intracorporeally with 3-port
Primary Outcome Measure Information:
Title
Operation time
Description
Time from skin incision to skin closure
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Postoperative complication rate
Description
Rate of 30 day complication or in-hospital complication
Time Frame
1 month
Title
postoperative hospital stay
Description
postoperative hospital stay
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung-Goo Lee, MD
Phone
+82-31-810-5445
Email
hashimot@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Goo Lee, MD
Organizational Affiliation
Myongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myongji Hospital, Hanyang university college of medicine
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
412-826
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung-Goo Lee, MD
Phone
+82-31-810-5445
Email
hashimot@naver.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30088968
Citation
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.
Results Reference
background
PubMed Identifier
29544230
Citation
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.
Results Reference
result
PubMed Identifier
21679587
Citation
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.
Results Reference
result
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Transumbilical Laparoscopy-assisted Appendectomy
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