Silo Versus Primary Closure for Gastroschisis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01506531
First received: January 2, 2012
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention
Gastroschisis
Procedure: silo
Procedure: Primary closure for gastroschisis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bedside Silo Versus Attempted Operative Closure for Gastroschisis

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Length of hospitalization [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
    The length of time required for meeting discharge criteria


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: primary closure of gastroschisis
attempted primary closure of gastroschisis on presentation
Procedure: Primary closure for gastroschisis
primary closure for gastroschisis if possible
Other Name: primary closure
Experimental: silo for gastroschisis
placement of silo for gastroschisis on presentation
Procedure: silo
silo placed around abdominal contents in gastroschisis patients
Other Name: silo

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.

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 2, 2012
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014