NCT02168426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

June 18, 2014

Last Update Submit

August 28, 2015

Conditions

Patient Under Going Colorectal and Stomach Cancer Surgery

Outcome Measures

Primary Outcomes (1)

  • ileus rate

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

    within 60 days

Secondary Outcomes (1)

  • adverse effect rate

    within 60 days

Study Arms (2)

Guardix

ACTIVE COMPARATOR

6g per body

Procedure: GuardixProcedure: Seprafilm

Seprafilm

ACTIVE COMPARATOR

1 sheet per body

Procedure: GuardixProcedure: Seprafilm

Interventions

GuardixPROCEDURE

Applying 6g of guardix during abdominal surgery

Also known as: Guardix, Sami pharmaceutical company, Seprafilm
GuardixSeprafilm
SeprafilmPROCEDURE

Applying 1 sheet of seprafilm during abdominal surgery

GuardixSeprafilm

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of GI cancer
  • Operable

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Won-Suk Lee

Incheon, South Korea

Location

MeSH Terms

Interventions

guardixSeprafilm

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Won-Suk Lee

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

KR(1)