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Silo Versus Primary Closure for Gastroschisis

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ClinicalTrials.gov Identifier: NCT01506531
Recruitment Status : Recruiting
First Posted : January 10, 2012
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroschisis Procedure: silo for gastroschisis Procedure: Primary closure of gastroschisis Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bedside Silo Versus Attempted Operative Closure for Gastroschisis
Study Start Date : January 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: primary closure of gastroschisis
Attempt primary skin closure of gastroschisis shortly after birth
Procedure: Primary closure of gastroschisis
Primary closure of gastroschisis, if possible

Active Comparator: silo for gastroschisis
Surgical placement of silo over gastroschisis shortly after birth
Procedure: silo for gastroschisis
silo placed around abdominal contents in gastroschisis patients




Primary Outcome Measures :
  1. Length of hospitalization [ Time Frame: 1-6 weeks ]
    The length of time required for meeting discharge criteria



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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506531


Contacts
Contact: Shawn D St. Peter, MD 816 983-6479 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816-983-6670 swsharp@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD    816-983-6479    sspeter@cmh.edu   
Contact: Susan W Sharp, PhD    816-983-6670    swsharp@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics

Responsible Party: Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01506531     History of Changes
Other Study ID Numbers: 11 09-156
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
gastroschisis
silo
primary closure

Additional relevant MeSH terms:
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical