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

Completed

• Conditions: Minimally Invasive Surgical Procedures
• Interventions: Procedure: Commercialized single-access port devices

• Registration Number: NCT05528003
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-06-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Deep/organ SSI	Complications happened within 30 days	SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification
Total surgical complications	Complications happened within 30 days	Complications were defined by Clavien-Dindo classification and comprehensive complication index.
Superficial incisional surgical site infection (SSI)	Complications happened within 30 days	SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification
Postoperative ileus	Complications happened within 30 days	Postoperative ileus was defined as the presence of symptoms and signs of abdominal distention, nausea, or vomiting combined with abdominal radiography, such as plain radiography or CT, within 30 days after SILA.

Secondary Outcome Measures

Name	Time	Method
Surgical time	Time from skin incision to application of gauzes	Total time needed for completing surgery
Total medical costs	From the time patient being brought to emergency room to the time patient being discharged	Medical costs were defined as the medical fees paid by the National Health Insurance and did not include the self-paid equipment fees needed in SILA (e.g., commercialized single-access port devices, or wound protector).
Postoperative length of hospitalization	Postoperative LOH was defined as the duration between leaving the recovery room and discharge.	Total time to stay in hospital
Time to resume soft diet	The time to resume a soft diet was measured as the duration between the time leaving the recovery room and the time to resume a soft diet recorded in the nursing note.	Total time needed to resume bowel ability to resuming soft diet