Transumbilical Laparoscopy-assisted Appendectomy

NCT ID: NCT04485247

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2022-03-31

Brief Summary

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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

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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

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Appendicitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional group

conventional laparoscopic appendectomy with 3-ports

Group Type ACTIVE_COMPARATOR

3-port laparoscopic appendectomy

Intervention Type PROCEDURE

appendectomy performed intracorporeally with 3-port

TULAA group

An operator extracts and ligates appendix through umbilical port.

Group Type EXPERIMENTAL

Transumbilical Laparoscopic-Assisted Appendectomy

Intervention Type PROCEDURE

appendectomy performed extracorporeally through umbilical port

Interventions

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Transumbilical Laparoscopic-Assisted Appendectomy

appendectomy performed extracorporeally through umbilical port

Intervention Type PROCEDURE

3-port laparoscopic appendectomy

appendectomy performed intracorporeally with 3-port

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyung-Goo Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung-Goo Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Myongji Hospital

Locations

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Myongji Hospital, Hanyang university college of medicine

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung-Goo Lee, MD

Role: CONTACT

+82-31-810-5445

Facility Contacts

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Kyung-Goo Lee, MD

Role: primary

+82-31-810-5445

References

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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.

Reference Type BACKGROUND
PMID: 30088968 (View on PubMed)

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.

Reference Type RESULT
PMID: 29544230 (View on PubMed)

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.

Reference Type RESULT
PMID: 21679587 (View on PubMed)

Other Identifiers

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Myongji Surgery

Identifier Type: -

Identifier Source: org_study_id

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