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Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168426
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Won-Suk Lee, 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.

Condition or disease Intervention/treatment Phase
Patient Under Going Colorectal and Stomach Cancer Surgery Procedure: Guardix Procedure: Seprafilm Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Guardix
6g per body
Procedure: Guardix
Applying 6g of guardix during abdominal surgery
Other Names:
  • Guardix, Sami pharmaceutical company
  • Seprafilm

Procedure: Seprafilm
Applying 1 sheet of seprafilm during abdominal surgery

Active Comparator: Seprafilm
1 sheet per body
Procedure: Guardix
Applying 6g of guardix during abdominal surgery
Other Names:
  • Guardix, Sami pharmaceutical company
  • Seprafilm

Procedure: Seprafilm
Applying 1 sheet of seprafilm during abdominal surgery




Primary Outcome Measures :
  1. ileus rate [ Time Frame: within 60 days ]
    Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations


Secondary Outcome Measures :
  1. adverse effect rate [ Time Frame: within 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168426


Locations
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Korea, Republic of
Won-Suk Lee
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
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Responsible Party: Won-Suk Lee, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT02168426    
Other Study ID Numbers: GDIRB2013-15
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents