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Homemade Versus Commercialized Single-access Port Devices in Single-incision Laparoscopic Appendectomy

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National Taiwan University

Status

Completed

Conditions

Minimally Invasive Surgical Procedures

Treatments

Procedure: Commercialized single-access port devices

Study type

Observational

Funder types

Other

Identifiers

NCT05528003
202104032RINB

Details and patient eligibility

About

Homemade and commercialized single-assess port devices are two kinds of port devices commonly used for single-incision laparoscopic appendectomy. This study aimed to compare these two port devices in terms of short-term surgical outcomes and medical costs.

Full description

The advantages of homemade port devices include accessibility of the composites and lower equipment costs to the patients; however, the potential disadvantage is the easy leakage of CO2, ballooning of the surgical glove, and device instability, leading to difficult maneuverability. On the other hand, commercialized port devices have relatively easy maneuverability, flexibility for instrument changes, and port stability for long-duration surgery ; however, their higher equipment cost is a disadvantage.

Enrollment

161 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy

Exclusion criteria

  • The patient was not diagnosed as acute appendicitis based on surgical finding or pathological findings
  • The patients underwent surgery other than single-incision laparoscopic surgery

Trial design

161 participants in 2 patient groups

Handmade single-access port device
Description:
The homemade single-access device was composed of a wound protector, sterile surgical glove, and three trocars inserted into and secured over three digits of the glove
Commercialized single-access port devices
Description:
Commercialized single-access port devices including GelPOINT® (Applied Medical, Rancho Santa Margarita, CA, USA) and LAGIPORT® (LAGIS, Taichung, Taiwan)
Treatment:
Procedure: Commercialized single-access port devices

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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