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CompletedNCT02168426Updated Sep 1, 2015

Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

A Phase 3 interventional study of Guardix and Seprafilm in Patient Under Going Colorectal and Stomach Cancer Surgery, sponsored by Gachon University Gil Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 25 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-09-01.

Sponsored by Gachon University Gil Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
25 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Patient Under Going Colorectal and Stomach Cancer Surgery

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's enrollment of 200 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 88 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of GI cancer
  • Operable

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Guardix

    6g per body

    Procedure: Guardix · Procedure: Seprafilm

  • Active comparator
    Seprafilm

    1 sheet per body

    Procedure: Guardix · Procedure: Seprafilm

Interventions

  • ProcedureGuardix

    Applying 6g of guardix during abdominal surgery

    Also known as: Guardix, Sami pharmaceutical company, Seprafilm

  • ProcedureSeprafilm

    Applying 1 sheet of seprafilm during abdominal surgery

06

What researchers measure

Primary outcomes

  1. ileus rate

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

    Time frame: within 60 days

Secondary outcomes

  1. adverse effect rate

    Time frame: within 60 days

07

Study locations

1 site
  • Won-Suk Lee
    Incheon, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02168426
Lead sponsor
Gachon University Gil Medical Center
Responsible party
Won-Suk Lee (Won-Suk Lee, Gachon University Gil Medical Center) — Principal investigator
First posted
Jun 20, 2014
Start date
Aug 2013
Primary completion
Dec 2014
Completion
Feb 2015
Last update
Sep 1, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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