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

Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580471
• Other study ID #: N202106033
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2022
• Est. completion date: September 4, 2024

Study information

• Verified date: October 2022
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Tungcheng Chang, PhD
• Phone: +886-2-22490088
• Email: rotring810[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 4, 2024
• Est. primary completion date: September 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesion
• Tissue Adhesions

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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang-Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of hospital stay	Number of days in hospital after surgery	7-14 days
Secondary	Complication	Complications within 30 days after surgery	30 days