Trial Outcomes & Findings for Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis (NCT NCT00539292)

NCT ID: NCT00539292

Last Updated: 2024-06-24

Results Overview

length of time on the ventilator

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 88 participants
• Primary outcome timeframe: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)
• Results posted on: 2024-06-24

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	28	27
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Silastic Spring-Loaded Silo Group n=27 Participants 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.	Primary Closure of Abdomen Group n=27 Participants 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.	Total n=54 Participants Total of all reporting groups
Age, Continuous	36.4 weeks STANDARD_DEVIATION 1.2 • n=5 Participants	36.7 weeks STANDARD_DEVIATION 1.0 • n=7 Participants	36.5 weeks STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Birth weight (g)	2446 grams STANDARD_DEVIATION 567 • n=5 Participants	2382 grams STANDARD_DEVIATION 391 • n=7 Participants	2414 grams STANDARD_DEVIATION 479 • n=5 Participants

PRIMARY outcome

Timeframe: Data collected daily during the first 14 days after the abdominal wall closure (measured in days)

length of time on the ventilator

Outcome measures

Measure	Silastic Spring-Loaded Silo Group n=27 Participants 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.	Primary Closure of Abdomen Group n=27 Participants 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.
Ventilation Status	3.17 days Standard Deviation 2.9	5.29 days Standard Deviation 5.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Silastic Spring-Loaded Silo Group n=15 Participants 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.	Primary Closure of Abdomen Group n=19 Participants 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.
Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure	10.9 mm Hg Standard Deviation 7	14.7 mm Hg Standard Deviation 5

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Silastic Spring-Loaded Silo Group n=27 Participants 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.	Primary Closure of Abdomen Group n=27 Participants 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.
TPN	38.8 days Standard Deviation 33	33 days Standard Deviation 27

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Silastic Spring-Loaded Silo Group n=27 Participants 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.	Primary Closure of Abdomen Group n=27 Participants 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.
Length of Hospital Stay	49.1 days Standard Deviation 34	43.2 days Standard Deviation 28

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Silastic Spring-Loaded Silo Group n=27 Participants 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.	Primary Closure of Abdomen Group n=27 Participants 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.
Complications During Hospitalization (e.g., Sepsis)	7 Participants	6 Participants

Adverse Events

Silastic Spring-Loaded Silo Group

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Primary Closure of Abdomen Group

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Silastic Spring-Loaded Silo Group n=27 participants at risk 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.	Primary Closure of Abdomen Group n=27 participants at risk 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.
Gastrointestinal disorders Short Bowel Syndrome	3.7% 1/27 • Number of events 1 • Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)	3.7% 1/27 • Number of events 1 • Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)

Other adverse events

Measure	Silastic Spring-Loaded Silo Group n=27 participants at risk 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.	Primary Closure of Abdomen Group n=27 participants at risk 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.
Gastrointestinal disorders Atresia	7.4% 2/27 • Number of events 2 • Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)	3.7% 1/27 • Number of events 1 • Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)

Additional Information

Dr Jacob C Langer

The Hospital for Sick Children

Phone: 416-813-7340

Email: jacob.langer@sickkids.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place