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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05528003
Enrollment
161
Registered
2022-09-06
Start date
2013-06-01
Completion date
2022-04-30
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally Invasive Surgical Procedures

Keywords

Single-incision laparoscopic appendectomy, Single-access port device

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.

Interventions

PROCEDURECommercialized single-access port devices

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative ileusComplications happened within 30 daysPostoperative 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.
Total surgical complicationsComplications happened within 30 daysComplications were defined by Clavien-Dindo classification and comprehensive complication index.
Superficial incisional surgical site infection (SSI)Complications happened within 30 daysSSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification
Deep/organ SSIComplications happened within 30 daysSSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification

Secondary

MeasureTime frameDescription
Surgical timeTime from skin incision to application of gauzesTotal time needed for completing surgery
Time to resume soft dietThe 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
Postoperative length of hospitalizationPostoperative LOH was defined as the duration between leaving the recovery room and discharge.Total time to stay in hospital
Total medical costsFrom the time patient being brought to emergency room to the time patient being dischargedMedical 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026