We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bedside Silo Versus Operative Closure for Gastroschisis

This study has been terminated.
(Change in referral pattern changed the population we were studying)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404690
First Posted: November 29, 2006
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
November 27, 2006
November 29, 2006
January 28, 2016
October 2006
April 2008   (Final data collection date for primary outcome measure)
this is a pilot study therefore there is no primary outcome variable [ Time Frame: 1 year ]
Length of Hospitalization
Complete list of historical versions of study NCT00404690 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
Bedside Silo Versus Operative Closure for Gastroschisis
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastroschisis
  • Procedure: Bedside Silo
    silo placed at bedside on admission
  • Procedure: Operative attempt at closure
    go the operating room to attempt closure
  • Active Comparator: 1
    Operative attempt at closure
    Intervention: Procedure: Operative attempt at closure
  • Experimental: 2
    bedside silo
    Intervention: Procedure: Bedside Silo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
October 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 1 Day   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00404690
06 09 141
No
Not Provided
Plan to Share IPD: No
Shawn St. Peter, Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Shawn D St. Peter, MD The Children's Mercy Hospital
Children's Mercy Hospital Kansas City
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP