Sutureless vs Sutured Gastroschisis Closure

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Sanjeev Dutta, Stanford University
ClinicalTrials.gov Identifier:
NCT01094587
First received: March 25, 2010
Last updated: June 21, 2013
Last verified: June 2013
  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: Sutureless gastroschisis closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sutureless vs Sutured Gastroschisis Closure

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Time on ventilator [ Designated as safety issue: No ]
  • Time to initiating enteral feeds [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cosmesis [ Time Frame: 6 months after hospital discharge ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Designated as safety issue: No ]
  • Complications including bowel resection, sepsis, and death. [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: November 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sutured closure Procedure: Sutureless gastroschisis closure
Active Comparator: Sutureless closure Procedure: Sutureless gastroschisis closure

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

Genders Eligible for Study:   Both
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
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: NCT01094587

Contacts
Contact: Sanjeev Dutta, MD (650) 723-6439 sdutta1@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Sanjeev Dutta, MD    650-723-6439    sdutta1@stanford.edu   
Contact: Susan Hintz, MD    (650) 497-8800    srhintz@stanford.edu   
Principal Investigator: Sanjeev Dutta         
Sub-Investigator: Susan Hintz         
Sub-Investigator: Matias Bruzoni, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sanjeev Dutta Stanford University
  More Information

No publications provided

Responsible Party: Sanjeev Dutta, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01094587     History of Changes
Other Study ID Numbers: SU-10142009-4180, IRB Protocol: 16918
Study First Received: March 25, 2010
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014