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Completed

NCT Number: NCT05528003

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

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.

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Key information

Conditions

Minimally Invasive Surgical Procedures

Age range

9 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Commercialized single-access port devices

Procedure

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

Primary outcomes

  1. Total surgical complications

    Time frame: Complications happened within 30 days

    Complications were defined by Clavien-Dindo classification and comprehensive complication index.

  2. Superficial incisional surgical site infection (SSI)

    Time frame: Complications happened within 30 days

    SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification

  3. Deep/organ SSI

    Time frame: Complications happened within 30 days

    SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification

  4. Postoperative ileus

    Time frame: 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 outcomes

  1. Surgical time

    Time frame: Time from skin incision to application of gauzes

    Total time needed for completing surgery

  2. Time to resume soft diet

    Time frame: 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

  3. Postoperative length of hospitalization

    Time frame: Postoperative LOH was defined as the duration between leaving the recovery room and discharge.

    Total time to stay in hospital

  4. Total medical costs

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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