Comparison of Homemade Versus Commercialized Single-access Port Devices for Single-incision Laparoscopic Appendectomy: A Retrospective Comparative Study
Sponsor study identifier
observational
161
0 countries
N/A
Study Start
June 1, 2013
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
April 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2013
Actual (reported)April 30, 2022
Actual (reported)April 30, 2022
Actual (reported)August 31, 2022
Actual (reported)September 6, 2022
Actual (reported)Total surgical complications
Complications were defined by Clavien-Dindo classification and comprehensive complication index.
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
Complications happened within 30 days
Deep/organ SSI
SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification
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.
Complications happened within 30 days
Surgical time
Time from skin incision to application of gauzes
Time to resume 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.
Postoperative length of hospitalization
Postoperative LOH was defined as the duration between leaving the recovery room and discharge.
Total medical costs
From the time patient being brought to emergency room to the time patient being discharged
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)
Two kinds of commercialized single-access port devices were used.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Acute appendicitis patients
Yu-Tso LIAO, MD
NTUH, Hsin-Chu Hospital
161 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2022
First Posted
September 6, 2022
Study Start
June 1, 2013
Actual (reported)Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study
Contact the study team to confirm eligibility.
Primary Completion
April 30, 2022
Actual (reported)Study Completion
April 30, 2022
Actual (reported)Last Updated
September 6, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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