Silo Versus Primary Closure for Gastroschisis

NCT ID: NCT01506531

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2018-04-30

Brief Summary

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The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.

Detailed Description

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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 length of hospitalization. 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.

Conditions

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Gastroschisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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primary closure of gastroschisis

Attempt primary skin closure of gastroschisis shortly after birth

Group Type ACTIVE_COMPARATOR

Primary closure of gastroschisis

Intervention Type PROCEDURE

Primary closure of gastroschisis, if possible

silo for gastroschisis

Surgical placement of silo over gastroschisis shortly after birth

Group Type ACTIVE_COMPARATOR

silo for gastroschisis

Intervention Type PROCEDURE

silo placed around abdominal contents in gastroschisis patients

Interventions

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silo for gastroschisis

silo placed around abdominal contents in gastroschisis patients

Intervention Type PROCEDURE

Primary closure of gastroschisis

Primary closure of gastroschisis, if possible

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Infants 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.
* Inability to get parental permission before treatment.
Minimum Eligible Age

5 Minutes

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Shawn St. Peter

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital and Clinics

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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11 09-156

Identifier Type: -

Identifier Source: org_study_id

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