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

Comparison of Homemade Versus Commercialized Single-access Port Devices for Single-incision Laparoscopic Appendectomy: A Retrospective Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Minimally Invasive Surgical Procedures
• Intervention / Treatment: Procedure: Commercialized single-access port devices

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.

• Study Type: Observational
• Enrollment (Actual): 161

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute appendicitis patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
Commercialized single-access port devices; Commercialized single-access port devices including GelPOINT® (Applied Medical, Rancho Santa Margarita, CA, USA) and LAGIPORT® (LAGIS, Taichung, Taiwan)	Procedure: Commercialized single-access port devices; Two kinds of commercialized single-access port devices were used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total surgical complications	Complications were defined by Clavien-Dindo classification and comprehensive complication index.	Complications happened within 30 days
Superficial incisional surgical site infection (SSI)	SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification	Complications happened within 30 days
Deep/organ SSI	SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification	Complications happened within 30 days
Postoperative ileus	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.	Complications happened within 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical time	Total time needed for completing surgery	Time from skin incision to application of gauzes
Time to resume soft diet	Total time needed to resume bowel ability to resuming 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.
Postoperative length of hospitalization	Total time to stay in hospital	Postoperative LOH was defined as the duration between leaving the recovery room and discharge.
Total medical costs	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).	From the time patient being brought to emergency room to the time patient being discharged

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yu-Tso LIAO, MD, NTUH, Hsin-Chu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Single-incision laparoscopic appendectomy; Single-access port device
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 202104032RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No