Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

Gachon University Gil Medical Center

Status and phase: Completed; Phase 3

Conditions: Patient Under Going Colorectal and Stomach Cancer Surgery

Treatments: Procedure: Guardix; Procedure: Seprafilm

Study type: Interventional

Funder types: Other

Identifiers

NCT02168426

GDIRB2013-15

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days postoperatively.

Enrollment: 200 patients

Sex: All

Ages: 25 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of GI cancer
• Operable

Exclusion criteria

• Withdrew consent
• Pregnant
• Ascites
• Distant metastasis
• Liver dysfunction (serum total bilirubin >2.0 mg/dL)
• Renal failure (serum creatinine >1.5 mg/dL)
• A past history of small bowel obstruction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Guardix

Active Comparator group

Description:

6g per body

Treatment:

Procedure: Seprafilm

Procedure: Guardix

Seprafilm

Active Comparator group

Description:

1 sheet per body

Treatment:

Procedure: Seprafilm

Procedure: Guardix