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

NCT ID: NCT05528003

Last Updated: 2022-09-06

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

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-01

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Minimally Invasive Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Handmade single-access port device

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

No interventions assigned to this group

Commercialized single-access port devices

Commercialized single-access port devices including GelPOINT® (Applied Medical, Rancho Santa Margarita, CA, USA) and LAGIPORT® (LAGIS, Taichung, Taiwan)

Commercialized single-access port devices

Intervention Type PROCEDURE

Two kinds of commercialized single-access port devices were used.

Interventions

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Commercialized single-access port devices

Two kinds of commercialized single-access port devices were used.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Tso LIAO, MD

Role: PRINCIPAL_INVESTIGATOR

NTUH, Hsin-Chu Hospital

Other Identifiers

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202104032RINB

Identifier Type: -

Identifier Source: org_study_id

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