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.

Study Overview

• Status: Terminated
• Conditions: Gastroschisis
• Intervention / Treatment: Procedure: Operative attempt at closure; Procedure: Bedside Silo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Operative attempt at closure	Procedure: Operative attempt at closure; go the operating room to attempt closure
Experimental: 2; bedside silo	Procedure: Bedside Silo; silo placed at bedside on admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
this is a pilot study therefore there is no primary outcome variable	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: November 27, 2006
• First Submitted That Met QC Criteria: November 28, 2006
• First Posted (Estimate): November 29, 2006

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Gastroschisis; Silo; Operative closure
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Musculoskeletal Abnormalities; Hernia; Gastroschisis
• Other Study ID Numbers: 06 09 141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO