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| Sponsored by: |
Children's Mercy Hospital Kansas City |
|---|---|
| Information provided by: | Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00404690 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastroschisis |
Procedure: Bedside Silo Procedure: Operative attempt at closure |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Bedside Silo Versus Attempted Operative Closure for Gastroschisis: A Pilot Study |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | October 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Operative attempt at closure
|
Procedure: Operative attempt at closure
go the operating room to attempt closure
|
|
2: Experimental
bedside silo
|
Procedure: Bedside Silo
silo placed at bedside on admission
|
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.
Eligibility| Ages Eligible for Study: | up to 1 Day |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shawn D St. Peter, MD | (816)234-3575 ext 6465 | sspeter@cmh.edu |
| Contact: Daniel J Ostlie, MD | (816)234-3575 ext 3884 | dostlie@cmh.edu |
| United States, Missouri | |
| The Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Shawn D St. Peter, MD 816-234-3575 ext 6465 sspeter@cmh.edu | |
| Principal Investigator: Shawn D St. Peter, MD | |
| Sub-Investigator: George W Holcomb III, MD | |
| Sub-Investigator: Daniel J Ostlie, MD | |
| Sub-Investigator: Susan W Sharp, PhD | |
| Principal Investigator: | Shawn D St. Peter, MD | The Children's Mercy Hospital |
More Information
| Study ID Numbers: | 06 09 141 |
| Study First Received: | November 27, 2006 |
| Last Updated: | November 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00404690 |
| Health Authority: | United States: Institutional Review Board |
|
Gastroschisis Silo Operative closure |
|
Pathological Conditions, Anatomical Musculoskeletal Diseases Hernia Hernia, Abdominal |
Gastroschisis Congenital Abnormalities Musculoskeletal Abnormalities |
