GastroschisisNCT01094587
Sutureless vs Sutured Gastroschisis Closure
A study testing Gastroschisis closure with suture and Gastroschisis closure without suture in people with Gastroschisis, run by Stanford University at 1 site in United States.
Trial summary
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroschisis
- What is being tested?
- Gastroschisis closure with suture and Gastroschisis closure without suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 24 Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria:Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.
Exclusion Criteria:Exclusion criteria are infants with other major abnormalities or medical conditions, grade IV intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.
Read the detailed description
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.
In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.
- Conditions
- Gastroschisis
- Being tested
- Gastroschisis closure with suture, Gastroschisis closure without suture
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastroschisis closure with sutureProcedure or surgery
Gastroschisis closure without sutureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sutured closure | Active comparator | Not described Receives: Procedure: Gastroschisis closure with suture |
| Sutureless closure | Active comparator | Not described Receives: Procedure: Gastroschisis closure without suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time on ventilator
Measured: Up to 1 week
Time to initiating enteral feeds
Measured: Up to 4 weeks
Secondary outcomes (3)
Cosmesis
Measured: 6 months after hospital discharge
Length of hospital stay
Measured: Up to 6 weeks
Complications including bowel resection, sepsis, and death.
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startNov 2009
- Primary completion24 Jun 2015
- Study completion24 Jun 2015
Why it stopped: Enrollment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Bruzoni, Stanford University
- Investigators
- Sanjeev Dutta, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094587
- Sponsor's protocol ID
- SU-10142009-4180
- Other IDs
- IRB Protocol: 16918
- Status last verified
- Oct 2017
- First submitted
- 25 Mar 2010
- Last updated
- 13 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless vs Sutured Gastroschisis Closure
- ClinicalTrials.gov ID
- NCT01094587
- Acronym / sponsor ID
- SU-10142009-4180
- Conditions
- Gastroschisis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulty
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- 24 Jun 2015 (actual)
- Study completion
- 24 Jun 2015 (actual)
- First posted
- 29 Mar 2010 (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.
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.
Detailed description
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.
In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sutured closure | Active comparator | Procedure: Gastroschisis closure with suture |
| Sutureless closure | Active comparator | Procedure: Gastroschisis closure without suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Gastroschisis closure with suture | Procedure or surgery | Sutured closure |
| Gastroschisis closure without suture | Procedure or surgery | Sutureless closure |
Primary outcome
Time on ventilator
Time frame: Up to 1 week
Time to initiating enteral feeds
Time frame: Up to 4 weeks
3 secondary outcomes
Cosmesis
Time frame: 6 months after hospital discharge
Length of hospital stay
Time frame: Up to 6 weeks
Complications including bowel resection, sepsis, and death.
Time frame: Up to 45 days
Results and safety
The study was stopped early (reason given: Enrollment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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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.
Sanjeev Dutta principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastroschisis closure with suture and Gastroschisis closure without suture in people with Gastroschisis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Enrollment difficulty). Results are not available in the source record.
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?
Time on ventilator (time frame: Up to 1 week). The study lists 2 primary outcomes in all. 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 13 Oct 2017.