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Sutureless vs Sutured Gastroschisis Closure

This study has been terminated.
(Enrollment difficulty)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01094587
First Posted: March 29, 2010
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matias Bruzoni, Stanford University
  Purpose
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

Condition Intervention
Gastroschisis Procedure: Gastroschisis closure with suture Procedure: Gastroschisis closure without suture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sutureless vs Sutured Gastroschisis Closure

Resource links provided by NLM:


Further study details as provided by Matias Bruzoni, Stanford University:

Primary Outcome Measures:
  • Time on ventilator [ Time Frame: Up to 1 week ]
  • Time to initiating enteral feeds [ Time Frame: Up to 4 weeks ]

Secondary Outcome Measures:
  • Cosmesis [ Time Frame: 6 months after hospital discharge ]
  • Length of hospital stay [ Time Frame: Up to 6 weeks ]
  • Complications including bowel resection, sepsis, and death. [ Time Frame: Up to 45 days ]

Enrollment: 39
Actual Study Start Date: November 2009
Study Completion Date: June 24, 2015
Primary Completion Date: June 24, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sutured closure Procedure: Gastroschisis closure with suture
Active Comparator: Sutureless closure Procedure: Gastroschisis closure without suture

Detailed Description:

This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.

Exclusion Criteria:Exclusion criteria are infants with other major abnormalities or medical conditions, grade IV intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.

  Contacts and Locations
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): NCT01094587


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sanjeev Dutta Stanford University
  More Information

Responsible Party: Matias Bruzoni, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01094587     History of Changes
Other Study ID Numbers: SU-10142009-4180
IRB Protocol: 16918
First Submitted: March 25, 2010
First Posted: March 29, 2010
Last Update Posted: October 13, 2017
Last Verified: October 2017

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