Intestinal ObstructionNCT00130715
Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
A study testing Seprafilm Bioresorbable Membrane in people with Intestinal Obstruction and Digestive System Surgical Procedures, run by Genzyme, a Sanofi Company at 21 sites in 5 countries.
Trial summary
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intestinal Obstruction, Digestive System Surgical Procedures
- What is being tested?
- Seprafilm Bioresorbable Membrane
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 21 sitesin 5 countries
- Study dates
- Jun 1998to Aug 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction
Who cannot join
- Patients with any medical condition or disease where 5-year survival was not expected
- Patients undergoing laparoscopy
- Patients undergoing surgery for treatment of acute abdominal trauma
- Patients with an abscess (abdominal or pelvic) present during the initial surgery
- Patients with a history of pulmonary embolus or deep vein thrombosis (DVT) within 1 year of surgery
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States16 sites
Johns Hopkins Medical Center
Baltimore, Maryland
Boston Medical Center
Boston, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts
Cleveland Clinic
Cleveland, Ohio
Duke University Medical Center
Durham, North Carolina
University of Texas Medical School
Houston, Texas
Kaiser Permanente Medical Center
Los Angeles, California
USC School of Medicine
Los Angeles, California
Mount Sinai School of Medicine
New York, New York
Mayo Medical Center
Rochester, Minnesota
Colon & Rectal Surgery Associates
Saint Paul, Minnesota
Mayo Clinic
Scottsdale, Arizona
Washington University School of Medicine
St Louis, Missouri
Harbor UCLA
Torrence, California
Washington Hospital Center
Washington D.C., District of Columbia
Cleveland Clinic
Weston, Florida
United Kingdom2 sites
University of Hull
Hull
St. Mary's Hospital
London
About this study
Official title: A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.
- Being tested
- Seprafilm Bioresorbable Membrane
- Keywords
- Patients undergoing a variety of abdominal surgical procedures
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seprafilm Bioresorbable MembraneDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2005 (estimated)
- Study startJun 1998
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130715
- Sponsor's protocol ID
- SF97-0601
- Status last verified
- Mar 2015
- First submitted
- 15 Aug 2005
- Last updated
- 12 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
- ClinicalTrials.gov ID
- NCT00130715
- Acronym / sponsor ID
- SF97-0601
- Keywords
- Patients undergoing a variety of abdominal surgical procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Study completion
- Aug 2003
- First posted
- 16 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction
Key exclusion criteria (5 listed)
- Patients with any medical condition or disease where 5-year survival was not expected
- Patients undergoing laparoscopy
- Patients undergoing surgery for treatment of acute abdominal trauma
- Patients with an abscess (abdominal or pelvic) present during the initial surgery
- Patients with a history of pulmonary embolus or deep vein thrombosis (DVT) within 1 year of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seprafilm Bioresorbable Membrane | Device | – |
Primary outcome
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seprafilm Bioresorbable Membrane in people with Intestinal Obstruction and Digestive System Surgical Procedures, run by Genzyme, a Sanofi Company at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, Canada, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2015.