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With the existing rate of patient accrual, it would take an extensive amount of time to reach the initial target of 88 patients. During this period, other changes in perioperative management of surgical neonates may invalidate the study comparisons.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Silastic Spring-Loaded Silo |
|
| 2 | Active Comparator | Primary Closure of Abdomen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary placement of a spring-loaded silo | Procedure |
| ||
| Primary Closure |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation Status | length of time on the ventilator | Data collected daily during the first 14 days after the abdominal wall closure (measured in days) |
| Measure | Description | Time Frame |
|---|---|---|
| Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure | intraabdominal pressure at the time of definitive closure | |
| TPN | use of total parenteral nutrition (TPN) | Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Langer, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18926212 | Result | Pastor AC, Phillips JD, Fenton SJ, Meyers RL, Lamm AW, Raval MV, Lehman E, Karp TB, Wales PW, Langer JC. Routine use of a SILASTIC spring-loaded silo for infants with gastroschisis: a multicenter randomized controlled trial. J Pediatr Surg. 2008 Oct;43(10):1807-12. doi: 10.1016/j.jpedsurg.2008.04.003. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silastic Spring-Loaded Silo Group | 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. |
| FG001 | Primary Closure of Abdomen Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was terminated in December 2006 (despite not achieving the initial target of 88 patients), the existing rate of patient accrual, would take an extensive amount of time to enter a planned number of patients; and during this period, other changes in perioperative management of surgical neonates may invalidate the study comparisons.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational age (wk) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ventilation Status | length of time on the ventilator | Posted | Mean | Standard Deviation | days | Data collected daily during the first 14 days after the abdominal wall closure (measured in days) |
|
Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silastic Spring-Loaded Silo Group | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Short Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atresia | Gastrointestinal disorders | Systematic Assessment |
Difficulty with patient enrollment because of parent refusal or absence for consent and individual surgeon preference not to randomize patients; this limited the number of patients enrolled and prevented adequate statistical power to be achieved.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jacob C Langer | The Hospital for Sick Children | 416-813-7340 | jacob.langer@sickkids.ca |
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| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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primary closure of abdomen |
|
| Length of Hospital Stay | days in hospital | Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge. |
| Complications During Hospitalization (e.g., Sepsis) | Clinical sepsis confirmed with a positive blood culture | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Birth weight (g) | Mean | Standard Deviation | grams |
|
| OG001 | Primary Closure of Abdomen Group | 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. |
|
|
| Secondary | Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure | 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. | Posted | Mean | Standard Deviation | mm Hg | intraabdominal pressure at the time of definitive closure |
|
|
|
| Secondary | TPN | use of total parenteral nutrition (TPN) | Posted | Mean | Standard Deviation | days | Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days) |
|
|
|
| Secondary | Length of Hospital Stay | days in hospital | Posted | Mean | Standard Deviation | days | Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge. |
|
|
|
| Secondary | Complications During Hospitalization (e.g., Sepsis) | Clinical sepsis confirmed with a positive blood culture | Posted | Count of Participants | Participants | 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. |
|
|
|
| 0 |
| 27 |
| 1 |
| 27 |
| 2 |
| 27 |
| EG001 | Primary Closure of Abdomen Group | 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. | 0 | 27 | 1 | 27 | 1 | 27 |
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| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |