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

NCT ID: NCT05580471

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-05

Study Completion Date

2024-09-04

Brief Summary

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

Detailed Description

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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

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Adhesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Use 4DryField

One group use 4DryField before wound closure. One group do not use 4DryField before wound closure.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Use 4DryField

One group use 4DryField before wound closure.

Group Type EXPERIMENTAL

Use 4DryField

Intervention Type DEVICE

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.

Not Use 4DryField

One group do not use 4DryField before wound closure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tungcheng Chang

Chief of colorectal surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tungcheng Chang, PhD

Role: STUDY_DIRECTOR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University Shuang-Ho Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tungcheng Chang, PhD

Role: CONTACT

+886-2-22490088 ext. 8123

Facility Contacts

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Tung-Cheng Chang, PhD

Role: primary

+886-2-22490088 ext. 8123

Other Identifiers

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N202106033

Identifier Type: -

Identifier Source: org_study_id

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