A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery
NCT ID: NCT05580471
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-03-05
2024-09-04
Brief Summary
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Detailed Description
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4DryField is a powder consisting of sterile hydrophilic microparticles, which is anufactured from highly purified potato starch in a complex process. A unique starch-based medical device is 4DryField® PH (4DryField; PlantTec Medical GmbH, Germany) as it is the only product proven to provide hemostasis and prevent the formation of adhesions. In rat model, the 4DryField acheieve the significant adhesion prevention effectiveness. In gynecologic surgery, 4DryField showed effective adhesion prevention as confirmed at second look laparoscopy. The gel is easilier to applied in the uneven surface of pelvic cavity and peristomy area than other manufacture. The indication of adhesion prevention is approved by TFDA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
One group use 4DryField before wound closure. One group do not use 4DryField before wound closure.
PREVENTION
NONE
Study Groups
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Use 4DryField
One group use 4DryField before wound closure.
Use 4DryField
Patients randomly use 4DryField in Colorectal resection combined with temporary stomy before fascia closure. We observed the adhesion severity and adhesion extent when stomy closure.
Not Use 4DryField
One group do not use 4DryField before wound closure.
No interventions assigned to this group
Interventions
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Use 4DryField
Patients randomly use 4DryField in Colorectal resection combined with temporary stomy before fascia closure. We observed the adhesion severity and adhesion extent when stomy closure.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
100 Years
ALL
No
Sponsors
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Taipei Medical University Shuang Ho Hospital
OTHER
Responsible Party
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Tungcheng Chang
Chief of colorectal surgery
Principal Investigators
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Tungcheng Chang, PhD
Role: STUDY_DIRECTOR
Taipei Medical University Shuang Ho Hospital
Locations
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Taipei Medical University Shuang-Ho Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N202106033
Identifier Type: -
Identifier Source: org_study_id
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