A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery
Primary Purpose
Adhesion
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Use 4DryField
Sponsored by
About this trial
This is an interventional prevention trial for Adhesion focused on measuring Adhesion, post-operation, Colorectal surgery
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing colorectal resection and temporary stoma
Exclusion Criteria:
- - Pregnancy, child, psychiatric disorder, behavior disorder, and prisoner. And those patients can't follow the protocol
Sites / Locations
- Taipei Medical University Shuang-Ho HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Use 4DryField
Not Use 4DryField
Arm Description
One group use 4DryField before wound closure.
One group do not use 4DryField before wound closure.
Outcomes
Primary Outcome Measures
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)
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 ).
Secondary Outcome Measures
Length of hospital stay
Number of days in hospital after surgery
Complication
Complications within 30 days after surgery
Full Information
NCT ID
NCT05580471
First Posted
October 9, 2022
Last Updated
October 12, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05580471
Brief Title
A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery
Official Title
A Randomized Control Study of 4DryField PH Anti-Adhesion Agent After Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2022 (Actual)
Primary Completion Date
September 4, 2024 (Anticipated)
Study Completion Date
September 4, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is to evaluate the difference of post-operation adhesion severity and adhesion area of patient received 4DryField after colorectal surgery.
Detailed Description
This proposal will investigate the effect of the newly anti-adhesive agent 4DryField. Stoma creation is common in complicated colorectal disease. Hartman procedure (End colostomy) is used in patients advanced rectal cancer or severe diverticulitis. Loop colostomy or ileostomy is used in patients need stool diversion for prevent leakage related infection.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesion
Keywords
Adhesion, post-operation, Colorectal surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Use 4DryField
One group use 4DryField before wound closure. One group do not use 4DryField before wound closure.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Use 4DryField
Arm Type
Experimental
Arm Description
One group use 4DryField before wound closure.
Arm Title
Not Use 4DryField
Arm Type
No Intervention
Arm Description
One group do not use 4DryField before wound closure.
Intervention Type
Device
Intervention Name(s)
Use 4DryField
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adhesion severity
Description
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)
Time Frame
0 days
Title
Adhesion extent
Description
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 ).
Time Frame
0 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Number of days in hospital after surgery
Time Frame
7-14 days
Title
Complication
Description
Complications within 30 days after surgery
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing colorectal resection and temporary stoma
Exclusion Criteria:
- Pregnancy, child, psychiatric disorder, behavior disorder, and prisoner. And those patients can't follow the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tungcheng Chang, PhD
Phone
+886-2-22490088
Ext
8123
Email
rotring810@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tungcheng Chang, PhD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University Shuang-Ho Hospital
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tung-Cheng Chang, PhD
Phone
+886-2-22490088
Ext
8123
Email
roussekimo@yahoo.com.tw
12. IPD Sharing Statement
Learn more about this trial
A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery
We'll reach out to this number within 24 hrs