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OpenTrials
Completed

NCT Number: NCT02168426

Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

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.

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Key information

Conditions

Patient Under Going Colorectal and Stomach Cancer Surgery

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Won-Suk Lee

Incheon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guardix

Procedure

Applying 6g of guardix during abdominal surgery

Other names: Guardix, Sami pharmaceutical company, Seprafilm

Seprafilm

Procedure

Applying 1 sheet of seprafilm during abdominal surgery

Primary outcomes

  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 outcomes

  1. adverse effect rate

    Time frame: within 60 days

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 20, 2014
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.