An observational study in Minimally Invasive Surgical Procedures, sponsored by National Taiwan University Hospital. Completed. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by National Taiwan University Hospital · Observational
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.
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.
National Taiwan University Hospital is the lead sponsor of 2,609 studies on the registry; 574 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Acute appendicitis patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
Total surgical complications
Complications were defined by Clavien-Dindo classification and comprehensive complication index.
Time frame: 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
Time frame: Complications happened within 30 days
Deep/organ SSI
SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification
Time frame: 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.
Time frame: Complications happened within 30 days
Surgical time
Total time needed for completing surgery
Time frame: Time from skin incision to application of gauzes
Time to resume soft diet
Total time needed to resume bowel ability to resuming 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
Total time to stay in hospital
Time frame: 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).
Time frame: From the time patient being brought to emergency room to the time patient being discharged
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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