A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
This project is to evaluate the difference of post-operation adhesion severity and adhesion area of patient received 4DryField after colorectal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2022
CompletedFirst Submitted
Initial submission to the registry
October 9, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2024
CompletedOctober 14, 2022
October 1, 2022
2.5 years
October 9, 2022
October 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adhesion severity
Adhesion severity was scored as grade 0 (no adhesion), grade I (filmy adhesion and blunt dissection), grade II (strong adhesion and sharp dissection), and grade III (very strong vascularized adhesion, sharp dissection, and damage barely preventable)
0 days
Adhesion extent
Adhesion area was scored as grade 0 (no adhesion), grade I (adhesion of less than one-third of the observational area), grade II (adhesion of one-third and two-thirds of the observational area), and grade III (adhesion of more than two-thirds of observational area ).
0 days
Secondary Outcomes (2)
Length of hospital stay
7-14 days
Complication
30 days
Study Arms (2)
Use 4DryField
EXPERIMENTALOne group use 4DryField before wound closure.
Not Use 4DryField
NO INTERVENTIONOne group do not use 4DryField before wound closure.
Interventions
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
You may qualify if:
- Patients undergoing colorectal resection and temporary stoma
You may not qualify if:
- \- Pregnancy, child, psychiatric disorder, behavior disorder, and prisoner. And those patients can't follow the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University Shuang-Ho Hospital
New Taipei City, 235, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tungcheng Chang, PhD
Taipei Medical University Shuang Ho Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of colorectal surgery
Study Record Dates
First Submitted
October 9, 2022
First Posted
October 14, 2022
Study Start
March 5, 2022
Primary Completion
September 4, 2024
Study Completion
September 4, 2024
Last Updated
October 14, 2022
Record last verified: 2022-10