Transumbilical Laparoscopy-assisted Appendectomy

Myongji Hospital

Status: Unknown

Conditions: Appendicitis Acute

Treatments: Procedure: Transumbilical Laparoscopic-Assisted Appendectomy; Procedure: 3-port laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04485247

Myongji Surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Conventional group

Active Comparator group

Description:

conventional laparoscopic appendectomy with 3-ports

Treatment:

Procedure: 3-port laparoscopic appendectomy

TULAA group

Experimental group

Description:

An operator extracts and ligates appendix through umbilical port.

Treatment:

Procedure: Transumbilical Laparoscopic-Assisted Appendectomy