Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02168426

Enrollment

200

Registered

2014-06-20

Start date

2013-08-31

Completion date

2015-02-28

Last updated

2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Under Going Colorectal and Stomach Cancer Surgery

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.

Interventions

PROCEDUREGuardix

Applying 6g of guardix during abdominal surgery

PROCEDURESeprafilm

Applying 1 sheet of seprafilm during abdominal surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

25 Years to 90 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
adverse effect rate	within 60 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026