Bedside Silo Versus Operative Closure for Gastroschisis
Primary Purpose
Gastroschisis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bedside Silo
Operative attempt at closure
Sponsored by
About this trial
This is an interventional treatment trial for Gastroschisis focused on measuring Gastroschisis, Silo, Operative closure
Eligibility Criteria
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.
Sites / Locations
- The Children's Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Operative attempt at closure
bedside silo
Outcomes
Primary Outcome Measures
this is a pilot study therefore there is no primary outcome variable
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00404690
First Posted
November 27, 2006
Last Updated
January 27, 2016
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT00404690
Brief Title
Bedside Silo Versus Operative Closure for Gastroschisis
Official Title
Bedside Silo Versus Attempted Operative Closure for Gastroschisis: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Change in referral pattern changed the population we were studying
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroschisis
Keywords
Gastroschisis, Silo, Operative closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Operative attempt at closure
Arm Title
2
Arm Type
Experimental
Arm Description
bedside silo
Intervention Type
Procedure
Intervention Name(s)
Bedside Silo
Intervention Description
silo placed at bedside on admission
Intervention Type
Procedure
Intervention Name(s)
Operative attempt at closure
Intervention Description
go the operating room to attempt closure
Primary Outcome Measure Information:
Title
this is a pilot study therefore there is no primary outcome variable
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bedside Silo Versus Operative Closure for Gastroschisis
We'll reach out to this number within 24 hrs