NCT01094587

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2015

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

5.6 years

First QC Date

March 25, 2010

Last Update Submit

October 12, 2017

Conditions

Gastroschisis

Outcome Measures

Primary Outcomes (2)

  • Time on ventilator

    Up to 1 week

  • Time to initiating enteral feeds

    Up to 4 weeks

Secondary Outcomes (3)

  • Cosmesis

    6 months after hospital discharge

  • Length of hospital stay

    Up to 6 weeks

  • Complications including bowel resection, sepsis, and death.

    Up to 45 days

Study Arms (2)

Sutured closure

ACTIVE COMPARATOR
Procedure: Gastroschisis closure with suture

Sutureless closure

ACTIVE COMPARATOR
Procedure: Gastroschisis closure without suture

Interventions

Gastroschisis closure with suturePROCEDURE
Sutured closure
Gastroschisis closure without suturePROCEDURE
Sutureless closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Gastroschisis

Interventions

Sutures

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Sanjeev Dutta

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

November 1, 2009

Primary Completion

June 24, 2015

Study Completion

June 24, 2015

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)