Transumbilical Laparoscopy-assisted Appendectomy

Not Applicable

• Conditions: Appendicitis Acute
• Interventions: Procedure: Transumbilical Laparoscopic-Assisted Appendectomy; Procedure: 3-port laparoscopic appendectomy

• Registration Number: NCT04485247
• Lead Sponsor: Myongji Hospital

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.

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-24
• Status Verified: 2020-08
• Study Start: 2020-08-03
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TULAA group	Transumbilical Laparoscopic-Assisted Appendectomy	An operator extracts and ligates appendix through umbilical port.
Conventional group	3-port laparoscopic appendectomy	conventional laparoscopic appendectomy with 3-ports

Primary Outcome Measures

Name	Time	Method
Operation time	1 day	Time from skin incision to skin closure

Secondary Outcome Measures

Name	Time	Method
Postoperative complication rate	1 month	Rate of 30 day complication or in-hospital complication
postoperative hospital stay	1 month	postoperative hospital stay

Trial Locations

Locations (1)

Myongji Hospital, Hanyang university college of medicine; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of