Adhesion
Conditions
Keywords
Adhesion, post-operation, 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.
Interventions
DEVICEUse 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.
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Use 4DryField One group use 4DryField before wound closure. One group do not use 4DryField before wound closure.
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 7-14 days | Number of days in hospital after surgery |
| Complication | 30 days | Complications within 30 days after surgery |
Countries
Taiwan
Contacts
Primary ContactTungcheng Chang, PhD
Outcome results
None listed