Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2006-12-31

Brief Summary

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This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.

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Detailed Description

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Standard treatment of the infant with gastroschisis consists of , the bowel being reduced into the abdomen, when possible,and the abdominal wall defect being closed in the operating room. When complete reduction of the eviscerated contents is not possible, a silastic " silo" is sewn on the abdominal wall and its contents are gradually reduced into the abdomen over several days. Once reduction is obtained, the silo is removed and the abdominal defect is closed.

Current methods of treatment are associated with significant morbidity, prolonged hospitalization, and high costs. Gastroschisis closure continues to be accompanied by a number of complications ranging from ileus, sepsis, TPN-related liver damage, necrotizing enterocolitis, respiratory insufficiency, and death. The optimal timing and method of closure, including primary versus secondary closure, continues to be debated. No prospective randomized studies to date have examined the routine use of the spring-loaded silo.

Conditions

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Gastroschisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Silastic Spring-Loaded Silo

Group Type EXPERIMENTAL

Primary placement of a spring-loaded silo

Intervention Type PROCEDURE

2

Primary Closure of Abdomen

Group Type ACTIVE_COMPARATOR

Primary Closure

Intervention Type PROCEDURE

primary closure of abdomen

Interventions

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Primary placement of a spring-loaded silo

Intervention Type PROCEDURE

Primary Closure

primary closure of abdomen

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Gastroschisis
* Birth Weight ≥ 1500 grams
* Gestational Age ≥ 34 weeks

Exclusion Criteria

* Birth Weight \< 1500 grams
* Gestational Age \< 34 weeks
* Presence of Bowel Ischemia or Necrosis
* Abdominal wall defect too small
* Major associated anomalies or medical condition
* Presence of Intracranial Hemorrhage (grade IV)
* Parent Refusal for Randomization

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No