Bedside Silo Versus Operative Closure for Gastroschisis

NCT ID: NCT00404690

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-10-31

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.

Conditions

Gastroschisis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Operative attempt at closure

Group Type: ACTIVE_COMPARATOR

Operative attempt at closure

Intervention Type: PROCEDURE

go the operating room to attempt closure

2

bedside silo

Group Type: EXPERIMENTAL

Bedside Silo

Intervention Type: PROCEDURE

silo placed at bedside on admission

Interventions

Bedside Silo

silo placed at bedside on admission

Intervention Type: PROCEDURE

Operative attempt at closure

go the operating room to attempt closure

Intervention Type: PROCEDURE

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.

• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Shawn St. Peter

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

The Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

06 09 141

Identifier Type: -

Identifier Source: org_study_id