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A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT05580471
Recruitment Status : Recruiting
First Posted : October 14, 2022
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Tungcheng Chang, Taipei Medical University Shuang Ho Hospital

Study Description
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Brief Summary:
This project is to evaluate the difference of post-operation adhesion severity and adhesion area of patient received 4DryField after colorectal surgery.

Condition or disease Intervention/treatment Phase
Adhesion Device: Use 4DryField Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Use 4DryField

One group use 4DryField before wound closure. One group do not use 4DryField before wound closure.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Control Study of 4DryField PH Anti-Adhesion Agent After Colorectal Surgery
Actual Study Start Date : March 5, 2022
Estimated Primary Completion Date : September 4, 2024
Estimated Study Completion Date : September 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Use 4DryField
One group use 4DryField before wound closure.
 Device: 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.
No Intervention: Not Use 4DryField
One group do not use 4DryField before wound closure.


Outcome Measures
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Primary Outcome Measures :
  1. Adhesion severity [ Time Frame: 0 days ]
    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)

  2. Adhesion extent [ Time Frame: 0 days ]
    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 :
  1. Length of hospital stay [ Time Frame: 7-14 days ]
    Number of days in hospital after surgery

  2. Complication [ Time Frame: 30 days ]
    Complications within 30 days after surgery


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05580471


Contacts
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Contact: Tungcheng Chang, PhD +886-2-22490088 ext 8123 rotring810@yahoo.com.tw

Locations
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Taiwan
Taipei Medical University Shuang-Ho Hospital Recruiting
New Taipei City, Taiwan, 235
Contact: Tung-Cheng Chang, PhD    +886-2-22490088 ext 8123    roussekimo@yahoo.com.tw   
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Study Director: Tungcheng Chang, PhD Taipei Medical University Shuang Ho Hospital
More Information
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Responsible Party: Tungcheng Chang, Chief of colorectal surgery, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT05580471    
Other Study ID Numbers: N202106033
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tungcheng Chang, Taipei Medical University Shuang Ho Hospital:
Adhesion
post-operation
Colorectal surgery
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes