Bedside Silo Versus Operative Closure for Gastroschisis
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2006 |
| End Date: | October 2008 |
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.
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.
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.
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.
Inclusion Criteria:
- Patients with gastroschisis
Exclusion Criteria:
- Born prior to 34 weeks estimated gestational age
- Another congenital anomaly influencing the respiratory status, gastrointestinal
status, or the length of hospitalization and recovery.
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