Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

Phase 3

Completed

• Conditions: Patient Under Going Colorectal and Stomach Cancer Surgery
• Interventions: Procedure: Guardix; Procedure: Seprafilm

• Registration Number: NCT02168426
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-20
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-28
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seprafilm	Seprafilm	1 sheet per body
Guardix	Guardix	6g per body
Guardix	Seprafilm	6g per body
Seprafilm	Guardix	1 sheet per body

Primary Outcome Measures

Name	Time	Method
ileus rate	within 60 days	Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations

Secondary Outcome Measures

Name	Time	Method
adverse effect rate	within 60 days

Trial Locations

Locations (1)

Won-Suk Lee; 🇰🇷 Incheon, Korea, Republic of