Bedside Silo Versus Operative Closure for Gastroschisis

Gastroschisis Clinical Trial

Official title:

Bedside Silo Versus Attempted Operative Closure for Gastroschisis: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00404690
• Other study ID #: 06 09 141
• Status: Terminated
• Phase: N/A
• First received: November 27, 2006
• Last updated: January 27, 2016
• Start date: October 2006
• Est. completion date: October 2008

Study information

• Verified date: January 2016
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroschisis

Intervention

Procedure:
• Bedside Silo
silo placed at bedside on admission
• Operative attempt at closure
go the operating room to attempt closure

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	this is a pilot study therefore there is no primary outcome variable		1 year
Secondary	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		1 year