Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

NCT ID: NCT02168426

Last Updated: 2015-09-01

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Patient Under Going Colorectal and Stomach Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Guardix

6g per body

Group Type ACTIVE_COMPARATOR

Guardix

Intervention Type PROCEDURE

Applying 6g of guardix during abdominal surgery

Seprafilm

Intervention Type PROCEDURE

Applying 1 sheet of seprafilm during abdominal surgery

Seprafilm

1 sheet per body

Group Type ACTIVE_COMPARATOR

Guardix

Intervention Type PROCEDURE

Applying 6g of guardix during abdominal surgery

Seprafilm

Intervention Type PROCEDURE

Applying 1 sheet of seprafilm during abdominal surgery

Interventions

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Guardix

Applying 6g of guardix during abdominal surgery

Intervention Type PROCEDURE

Seprafilm

Applying 1 sheet of seprafilm during abdominal surgery

Intervention Type PROCEDURE

Other Intervention Names

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Guardix, Sami pharmaceutical company Seprafilm

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won-Suk Lee

Won-Suk Lee

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Won-Suk Lee

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GDIRB2013-15

Identifier Type: -

Identifier Source: org_study_id

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