Transumbilical Laparoscopy-assisted Appendectomy

Appendicitis Acute Clinical Trial

Official title:

Is Transumbilical Laparoscopy-assisted Appendectomy in the Pediatric Acute Uncomplicated Appendicitis Superior to Conventional 3 Port Laparoscopic Appendectomy?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485247
• Other study ID #: Myongji Surgery
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: March 2022

Study information

• Verified date: August 2020
• Source: Myongji Hospital
• Contact: Kyung-Goo Lee, MD
• Phone: +82-31-810-5445
• Email: hashimot[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

Procedure:
• Transumbilical Laparoscopic-Assisted Appendectomy
appendectomy performed extracorporeally through umbilical port
• 3-port laparoscopic appendectomy
appendectomy performed intracorporeally with 3-port

Locations

Country	Name	City	State
Korea, Republic of	Myongji Hospital, Hanyang university college of medicine	Goyang	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Myongji Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Dübbers 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): — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	Time from skin incision to skin closure	1 day
Secondary	Postoperative complication rate	Rate of 30 day complication or in-hospital complication	1 month
Secondary	postoperative hospital stay	postoperative hospital stay	1 month