Minimally Invasive Surgical ProceduresNCT05528003
Homemade Versus Commercialized Single-access Port Devices in Single-incision Laparoscopic Appendectomy
An observational study of Minimally Invasive Surgical Procedures, run by National Taiwan University Hospital.
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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Minimally Invasive Surgical Procedures
- What is being tested?
- Commercialized single-access port devices
- Type of treatment
- Surgery or procedure
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute appendicitis patients
Who may be able to join
- The patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Minimally Invasive Surgical Procedures
- Being tested
- Commercialized single-access port devices
- Keywords
- Single-incision laparoscopic appendectomy, Single-access port device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercialized single-access port devicesProcedure or surgery
Two kinds of commercialized single-access port devices were used.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Commercialized single-access port devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total surgical complications
Complications were defined by Clavien-Dindo classification and comprehensive complication index.
Measured: 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
Measured: Complications happened within 30 days
Deep/organ SSI
SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification
Measured: 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.
Measured: Complications happened within 30 days
Secondary outcomes (4)
Surgical time
Total time needed for completing surgery
Measured: Time from skin incision to application of gauzes
Time to resume soft diet
Total time needed to resume bowel ability to resuming soft diet
Measured: 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
Measured: 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).
Measured: From the time patient being brought to emergency room to the time patient being discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Jun 2013
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Tso LIAO, MD, Principal investigator, NTUH, Hsin-Chu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528003
- Sponsor's protocol ID
- 202104032RINB
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Homemade Versus Commercialized Single-access Port Devices for Single-incision Laparoscopic Appendectomy: A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT05528003
- Acronym / sponsor ID
- 202104032RINB
- Conditions
- Minimally Invasive Surgical Procedures
- Keywords
- Single-incision laparoscopic appendectomy, Single-access port device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: Commercialized single-access port devicesCommercialized single-access port devices including GelPOINT® (Applied Medical, Rancho Santa Margarita, CA, USA) and LAGIPORT® (LAGIS, Taichung, Taiwan) |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute appendicitis patients
Key inclusion criteria (1 listed)
- The patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercialized single-access port devicesTwo kinds of commercialized single-access port devices were used. | Procedure or surgery | Commercialized single-access port devices |
Primary outcome
Total surgical complications
Time frame: Complications happened within 30 days
Complications were defined by Clavien-Dindo classification and comprehensive complication index.
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
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
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.
4 secondary outcomes
Surgical time
Time frame: Time from skin incision to application of gauzes
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.
Postoperative length of hospitalization
Time frame: Postoperative LOH was defined as the duration between leaving the recovery room and discharge.
Total medical costs
Time frame: From the time patient being brought to emergency room to the time patient being discharged
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Tso LIAO, MD principal investigator
NTUH, Hsin-Chu Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Surgical Procedures, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total surgical complications (time frame: Complications happened within 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.