MedPath

Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

Phase 3
Completed
Conditions
Patient Under Going Colorectal and Stomach Cancer Surgery
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

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
Primary Outcome Measures
NameTimeMethod
ileus ratewithin 60 days

Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations

Secondary Outcome Measures
NameTimeMethod
adverse effect ratewithin 60 days

Trial Locations

Locations (1)

Won-Suk Lee

🇰🇷

Incheon, Korea, Republic of

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

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