GastroschisisNCT00404690
Bedside Silo Versus Operative Closure for Gastroschisis
A study testing Bedside Silo and Operative attempt at closure in people with Gastroschisis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay. The primary outcome variable between the two techniques will be determined from this study that can then be used to develop a definitive study. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Gastroschisis
- What is being tested?
- Bedside Silo and Operative attempt at closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2008
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with gastroschisis
Who cannot join
- Born prior to 34 weeks estimated gestational age
- Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Bedside Silo Versus Attempted Operative Closure for Gastroschisis: A Pilot Study
The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.
The primary outcome variable between the two techniques will be determined from this study that can then be used to develop a definitive study. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.
Read the detailed description
A strategy of blocked randomization will be utilized. The randomization will be blocked in groups of 4. Randomization sequence will be kept by the principal investigator. After permission is obtained, the next assignment will be obtained. This method assures that the physician obtaining permission will be blind to the treatment group.
The treatment groups will consist of the same medical management, feeding regimen and discharge criteria.
The interventions will be either bedside silo or operative attempt at closure. During attempt at primary closure, the abdomen will be closed completely if the staff anesthesiologist and surgeon agree the belly is not too tight based on ventilatory parameters, vital signs and appearance. If either the surgeon or anesthesiologist should feel the closed abdomen is too tight, a ringed silo will be placed in the operating room, the same silo used in the bedside treatment arm, and the child will continue in the study. When a silo is placed either in the operating room due to inability to close the abdomen or at the bedside, they will be managed the same way. The skin will be dressed in the standard fashion (betadine jelly, xeroform and kerlix). The dressing allows visualization of the bowel. No reductions will be done the day of placement. After one night of observation a tie will be gently placed to apply downward pressure on the bowel. This pressure will not be allowed to increase the peak ventilator pressure by more than 2 cm H2O. One tie will be placed each subsequent day until the tie is within 2 cm of the skin at which point the patient will be scheduled for operative closure the day following the placement of the tie.
The medical management is controlled for resuscitation, sedation, ventilation and feeding between groups.
- Conditions
- Gastroschisis
- Being tested
- Bedside Silo, Operative attempt at closure
- Keywords
- Gastroschisis, Silo, Operative closure
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside SiloProcedure or surgery
silo placed at bedside on admission
Operative attempt at closureProcedure or surgery
go the operating room to attempt closure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Operative attempt at closure Receives: Procedure: Operative attempt at closure |
| 2 | Experimental | bedside silo Receives: Procedure: Bedside Silo |
What is being measured
The primary outcome is the main question the study is designed to answer.
this is a pilot study therefore there is no primary outcome variable
Measured: 1 year
Secondary outcomes (1)
Time to full feeds, time of ventilation, hospital charges, total time in the operating room, number of operations, fluid resuscitation, total transfusion volume, fluid re
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionOct 2008
Why it stopped: Change in referral pattern changed the population we were studying
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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404690
- Sponsor's protocol ID
- 06 09 141
- Status last verified
- Jan 2016
- First submitted
- 27 Nov 2006
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Silo Versus Attempted Operative Closure for Gastroschisis: A Pilot Study
- ClinicalTrials.gov ID
- NCT00404690
- Acronym / sponsor ID
- 06 09 141
- Conditions
- Gastroschisis
- Keywords
- Gastroschisis, Silo, Operative closure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in referral pattern changed the population we were studying
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Nov 2006 (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 hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.
The primary outcome variable between the two techniques will be determined from this study that can then be used to develop a definitive study. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.
Detailed description
A strategy of blocked randomization will be utilized. The randomization will be blocked in groups of 4. Randomization sequence will be kept by the principal investigator. After permission is obtained, the next assignment will be obtained. This method assures that the physician obtaining permission will be blind to the treatment group.
The treatment groups will consist of the same medical management, feeding regimen and discharge criteria.
The interventions will be either bedside silo or operative attempt at closure. During attempt at primary closure, the abdomen will be closed completely if the staff anesthesiologist and surgeon agree the belly is not too tight based on ventilatory parameters, vital signs and appearance. If either the surgeon or anesthesiologist should feel the closed abdomen is too tight, a ringed silo will be placed in the operating room, the same silo used in the bedside treatment arm, and the child will continue in the study. When a silo is placed either in the operating room due to inability to close the abdomen or at the bedside, they will be managed the same way. The skin will be dressed in the standard fashion (betadine jelly, xeroform and kerlix). The dressing allows visualization of the bowel. No reductions will be done the day of placement. After one night of observation a tie will be gently placed to apply downward pressure on the bowel. This pressure will not be allowed to increase the peak ventilator pressure by more than 2 cm H2O. One tie will be placed each subsequent day until the tie is within 2 cm of the skin at which point the patient will be scheduled for operative closure the day following the placement of the tie.
The medical management is controlled for resuscitation, sedation, ventilation and feeding between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Operative attempt at closureOperative attempt at closure |
| 2 | Experimental | Procedure: Bedside Silobedside silo |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with gastroschisis
Key exclusion criteria (2 listed)
- Born prior to 34 weeks estimated gestational age
- Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
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 |
|---|---|---|
| Bedside Silosilo placed at bedside on admission | Procedure or surgery | 2 |
| Operative attempt at closurego the operating room to attempt closure | Procedure or surgery | 1 |
Primary outcome
this is a pilot study therefore there is no primary outcome variable
Time frame: 1 year
1 secondary outcome
Time to full feeds, time of ventilation, hospital charges, total time in the operating room, number of operations, fluid resuscitation, total transfusion volume, fluid re
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Change in referral pattern changed the population we were studying). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside Silo and Operative attempt at closure in people with Gastroschisis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 28 Jan 2016. 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: Change in referral pattern changed the population we were studying). 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?
this is a pilot study therefore there is no primary outcome variable (time frame: 1 year). 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 28 Jan 2016.