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

Minimally Invasive Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528003
• Other study ID #: 202104032RINB
• Status: Completed
• Start date: June 1, 2013
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Minimally Invasive Surgical Procedures
• Surgical Wound

Intervention

Procedure:
• Commercialized single-access port devices
Two kinds of commercialized single-access port devices were used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total surgical complications	Complications were defined by Clavien-Dindo classification and comprehensive complication index.	Complications happened within 30 days
Primary	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
Primary	Deep/organ SSI	SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification	Complications happened within 30 days
Primary	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	Surgical time	Total time needed for completing surgery	Time from skin incision to application of gauzes
Secondary	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.
Secondary	Postoperative length of hospitalization	Total time to stay in hospital	Postoperative LOH was defined as the duration between leaving the recovery room and discharge.
Secondary	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