NCT05580471

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

A Randomized Control Study of 4DryField PH Anti-Adhesion Agent After Colorectal Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adhesion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-05
• Primary completion: 2024-09-04
• Completion: 2024-09-04
• First posted: 2022-10-14
• Last updated: 2022-10-14

Locations

1 site across 1 country: Taiwan