NCT04485247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

July 20, 2020

Last Update Submit

August 31, 2020

Conditions

Appendicitis Acute

Outcome Measures

Primary Outcomes (1)

  • Operation time

    Time from skin incision to skin closure

    1 day

Secondary Outcomes (2)

  • Postoperative complication rate

    1 month

  • postoperative hospital stay

    1 month

Study Arms (2)

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

Transumbilical Laparoscopic-Assisted AppendectomyPROCEDURE

appendectomy performed extracorporeally through umbilical port

TULAA group
3-port laparoscopic appendectomyPROCEDURE

appendectomy performed intracorporeally with 3-port

Conventional group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous abdominal operation
  • Generalized peritonitis
  • Anticipated extended resection
  • Periappendiceal abscess on preoperative exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Myongji Hospital, Hanyang university college of medicine

Goyang-si, Gyeonggi-do, 412-826, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30088968BACKGROUND

  • 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.

    PMID: 29544230RESULT

  • 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.

    PMID: 21679587RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Kyung-Goo Lee, MD

    Myongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung-Goo Lee, MD

CONTACT

+82-31-810-5445hashimot@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 24, 2020

Study Start

August 3, 2020

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

all individual participant data that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
starting 6 months after publication
Access Criteria
all individual participant data that underlie results in a publication

Locations

KR(1)