Gastroschisis
Conditions
Keywords
pediatrics, gastroschisis, silastic spring-loaded silo
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPrimary placement of a spring-loaded silo
PROCEDUREPrimary Closure
primary closure of abdomen
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilation Status | Data collected daily during the first 14 days after the abdominal wall closure (measured in days) | length of time on the ventilator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TPN | Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days) | use of total parenteral nutrition (TPN) |
| Length of Hospital Stay | Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge. | days in hospital |
| Complications During Hospitalization (e.g., Sepsis) | post-surgery to hospital discharge; Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge. | Clinical sepsis confirmed with a positive blood culture |
| Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure | intraabdominal pressure at the time of definitive closure | — |
Countries
Canada
Participant flow
Recruitment details
A total of 195 infants with gastroschisis were admitted to the participating centers between June 2001 and December 2006. After screening for eligibility and obtaining consent for enrollment, 55 patients were randomized. A randomization plan was generated by the lead center through an electronic Web-based randomization program.
Pre-assignment details
55 patients were randomized, 28 infants in the spring-loaded silo group and 27 infants in the primary closure group. One patient in the spring-loaded silo group was excluded from the study because of repeated dislodg-ement of the silo, requiring use of a sewn prosthetic device and inability to perform secondary closure.
Participants by arm
| Arm | Count |
|---|---|
| Silastic Spring-Loaded Silo Group Silastic Spring-Loaded Silo Group
Primary placement of a spring-loaded silo
Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.
Patients were assigned to 1 of the 2 groups using the sealed-envelope method. 28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique. | 27 |
| Primary Closure of Abdomen Group Primary Closure of Abdomen Group
Primary Closure: primary closure of abdomen
Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.
Patients were assigned to 1 of the 2 groups using the sealed-envelope method. 27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure. | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Silastic Spring-Loaded Silo Group | Primary Closure of Abdomen Group | Total |
|---|---|---|---|
| Age, Continuous | 36.4 weeks STANDARD_DEVIATION 1.2 | 36.7 weeks STANDARD_DEVIATION 1 | 36.5 weeks STANDARD_DEVIATION 1.1 |
| Birth weight (g) | 2446 grams STANDARD_DEVIATION 567 | 2382 grams STANDARD_DEVIATION 391 | 2414 grams STANDARD_DEVIATION 479 |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 30 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 2 / 27 | 1 / 27 |
| serious Total, serious adverse events | 1 / 27 | 1 / 27 |
Outcome results
Primary
Ventilation Status
length of time on the ventilator
Time frame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silastic Spring-Loaded Silo Group | Ventilation Status | 3.17 days | Standard Deviation 2.9 |
| Primary Closure of Abdomen Group | Ventilation Status | 5.29 days | Standard Deviation 5.2 |
Secondary
Complications During Hospitalization (e.g., Sepsis)
Clinical sepsis confirmed with a positive blood culture
Time frame: post-surgery to hospital discharge; Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silastic Spring-Loaded Silo Group | Complications During Hospitalization (e.g., Sepsis) | 7 Participants |
| Primary Closure of Abdomen Group | Complications During Hospitalization (e.g., Sepsis) | 6 Participants |
Secondary
Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure
Time frame: intraabdominal pressure at the time of definitive closure
Population: The analysis of lAP at the time of abdominal wall closure was subject to adjustment as the data measured by intragastric catheter were only available for 15 patients in the spring-loaded silo group and 19 patients in the primary closure group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silastic Spring-Loaded Silo Group | Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure | 10.9 mm Hg | Standard Deviation 7 |
| Primary Closure of Abdomen Group | Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure | 14.7 mm Hg | Standard Deviation 5 |
Secondary
Length of Hospital Stay
days in hospital
Time frame: Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silastic Spring-Loaded Silo Group | Length of Hospital Stay | 49.1 days | Standard Deviation 34 |
| Primary Closure of Abdomen Group | Length of Hospital Stay | 43.2 days | Standard Deviation 28 |
Secondary
TPN
use of total parenteral nutrition (TPN)
Time frame: Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silastic Spring-Loaded Silo Group | TPN | 38.8 days | Standard Deviation 33 |
| Primary Closure of Abdomen Group | TPN | 33 days | Standard Deviation 27 |