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Sutureless vs Sutured Gastroschisis Closure

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ClinicalTrials.gov Identifier: NCT01094587
Recruitment Status : Terminated (Enrollment difficulty)
First Posted : March 29, 2010
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Matias Bruzoni, Stanford University

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date October 13, 2017
Actual Study Start Date  ICMJE November 2009
Actual Primary Completion Date June 24, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • Time on ventilator [ Time Frame: Up to 1 week ]
  • Time to initiating enteral feeds [ Time Frame: Up to 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • Time on ventilator
  • Time to initiating enteral feeds
Change History Complete list of historical versions of study NCT01094587 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • Cosmesis [ Time Frame: 6 months after hospital discharge ]
  • Length of hospital stay
  • Complications including bowel resection, sepsis, and death.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sutureless vs Sutured Gastroschisis Closure
Official Title  ICMJE Sutureless vs Sutured Gastroschisis Closure
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroschisis
Intervention  ICMJE
  • Procedure: Gastroschisis closure with suture
  • Procedure: Gastroschisis closure without suture
Study Arms  ICMJE
  • Active Comparator: Sutured closure
    Intervention: Procedure: Gastroschisis closure with suture
  • Active Comparator: Sutureless closure
    Intervention: Procedure: Gastroschisis closure without suture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 12, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2010)
54
Actual Study Completion Date  ICMJE June 24, 2015
Actual Primary Completion Date June 24, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094587
Other Study ID Numbers  ICMJE SU-10142009-4180
IRB Protocol: 16918
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matias Bruzoni, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjeev Dutta Stanford University
PRS Account Stanford University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP