Transumbilical Laparoscopy-assisted Appendectomy | NCT04485247

Studies
Transumbilical Laparoscopy-assisted Appendectomy

NCT04485247

Sponsor

Myongji Hospital

Status

Unknown status

Last Update Posted

Sep 2, 2020Actual

Enrollment

78Estimated

Phase

Not Applicable

Conditions

Appendicitis Acute

Interventions

Transumbilical Laparoscopic-Assisted Appendectomy
3-port laparoscopic appendectomy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2020Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Jul 20, 2020

First Submission Date that Met QC Criteria

Jul 23, 2020

First Posted Date

Jul 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kyung-Goo Lee, Assistant professor, Myongji HospitalPrincipal Investigator

Lead Sponsor

Myongji HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional group	Active Comparator	conventional laparoscopic appendectomy with 3-ports	Procedure: 3-port laparoscopic appendectomy
TULAA group	Experimental	An operator extracts and ligates appendix through umbilical port.	Procedure: Transumbilical Laparoscopic-Assisted Appendectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transumbilical Laparoscopic-Assisted Appendectomy	Procedure	appendectomy performed extracorporeally through umbilical port	TULAA group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operation time	Time from skin incision to skin closure	1 day

Secondary Outcomes

Measure	Description	Time Frame
Postoperative complication rate	Rate of 30 day complication or in-hospital complication	1 month
postoperative hospital stay	postoperative hospital stay

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyung-Goo Lee, MD	Contact	+82-31-810-5445		hashimot@naver.com

Overall Officials

Name	Affiliation	Role
Kyung-Goo Lee, MD	Myongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Myongji Hospital, Hanyang university college of medicine	Recruiting	Goyang-si	Gyeonggi-do	412-826	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30088968	Background	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.
29544230

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases