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

Not Applicable

Recruiting

• Conditions: Adhesion
• Interventions: Device: Use 4DryField

• Registration Number: NCT05580471
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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 Timeline

• Study Start: 2022-03-05
• Status Verified: 2022-10
• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-09-04
• Study Completion: 2024-09-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use 4DryField	Use 4DryField	One group use 4DryField before wound closure.

Primary Outcome Measures

Name	Time	Method
Adhesion severity	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	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

Name	Time	Method
Length of hospital stay	7-14 days	Number of days in hospital after surgery
Complication	30 days	Complications within 30 days after surgery

Trial Locations

Locations (1)

Taipei Medical University Shuang-Ho Hospital; 🇨🇳 New Taipei City, Taiwan