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

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

Tracking Information

• First Submitted Date: October 9, 2022
• First Posted Date: October 14, 2022
• Last Update Posted Date: October 14, 2022
• Actual Study Start Date: March 5, 2022
• Estimated Primary Completion Date: September 4, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 12, 2022)

• 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)
• 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 ).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 12, 2022)

• Length of hospital stay [ Time Frame: 7-14 days ]
  Number of days in hospital after surgery
• Complication [ Time Frame: 30 days ]
  Complications within 30 days after surgery

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Adhesion

Intervention

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.

Study Arms

• Experimental: Use 4DryField
  One group use 4DryField before wound closure.
  Intervention: Device: Use 4DryField
• No Intervention: Not Use 4DryField
  One group do not use 4DryField before wound closure.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 12, 2022): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 4, 2024
• Estimated Primary Completion Date: September 4, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT05580471
• Other Study ID Numbers: N202106033
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Tungcheng Chang, Taipei Medical University Shuang Ho Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Taipei Medical University Shuang Ho Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Tungcheng Chang, PhD; Taipei Medical University Shuang Ho Hospital

• PRS Account: Taipei Medical University Shuang Ho Hospital
• Verification Date: October 2022