A, Initial presentation of infant after delivery with eviscerated bowel. B, Abdomen after reduction of contents over time with a silastic silo; the umbilical stalk is then draped over the remaining abdominal wall defect. C, The umbilical stalk is reinforced over the abdominal wall defect with multiple skin-closure strips. D, Skin-closure strips and umbilical remnant are then covered with silver-impregnated foam dressing.
eFigure. Types of Repair and Outcome Measures Over Time
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Witt RG, Zobel M, Padilla B, Lee H, MacKenzie TC, Vu L. Evaluation of Clinical Outcomes of Sutureless vs Sutured Closure Techniques in Gastroschisis Repair. JAMA Surg. 2019;154(1):33–39. doi:10.1001/jamasurg.2018.3216
Is sutureless gastroschisis repair associated with improvements in clinical outcomes when compared with sutured gastroschisis repair?
In this cohort review of 97 neonates who underwent gastroschisis correction, patients who received sutureless closure, compared with those who had sutured closure, had shorter durations of mechanical ventilation, less pain medication use, and higher rates of umbilical hernias requiring surgical repair. No substantial differences were found between the 2 groups in wound infection rates, time to full enteral feeds, total parenteral nutrition duration, length of hospital stay, and serious complication rates.
Sutureless gastroschisis repair may substantially decrease mechanical ventilation duration and pain medication requirement but could increase umbilical hernia risk; multicenter randomized clinical trials are necessary to determine the true advantages of the sutureless approach.
Sutureless gastroschisis repair offers an alternative to the traditional sutured method and has been associated with decreased intubation time. Published study results are inconsistent regarding the advantages of sutureless closure.
To compare the clinical outcomes of sutureless and sutured gastroschisis repair.
Design, Setting, and Participants
A single-center cohort review was performed of all consecutive patients (n = 97) who underwent gastroschisis repair from February 1, 2007, to April 30, 2017, at the University of California, San Francisco. Patients’ medical records were evaluated for clinical characteristics and outcomes. Cases with incomplete data during initial hospitalization were excluded.
Main Outcomes and Measures
Length of hospital stay, time to full enteral feeds, total parenteral nutrition duration, days requiring intravenous analgesia, days intubated, wound infection rate, antibiotic treatment duration, rate of umbilical hernias that required an operation, and readmission rate.
In total, 97 patients (47 [48%] were female and 50 [52%] were male with a mean [SD] age of 2.8 [2.8] days) underwent gastroschisis repair, of which 7 were excluded for incomplete medical record. Of the 90 patients included in the study, 50 (56%) underwent sutured closure and 40 (44%) underwent sutureless closure. No statistical difference was found between the sutured and sutureless groups in length of hospital stay (mean [SD] days, 43.9 [40.4] vs 36.7 [21.2]; P = .71), time to full enteral feeds (mean [SD] days, 31.4 [20.2] vs 27.9 [17.3]; P = .22), total parenteral nutrition duration (mean [SD] days, 33.5 [29.8] vs 27.4 [18.2]; P = .23), wound infection rates (14 [28%] vs 10 [25%]; P = .81), and readmission rates (5 [10%] vs 7 [18%]; P = .36). The sutureless group, compared with the sutured group, had substantially fewer days receiving antibiotics (mean [SD], 7.2 [6.4] vs 12.4 [13.2]; P = .003), fewer days intubated (mean [SD], 2.8 [3.3] vs 6.8 [1.3]; P = .001), fewer days receiving intravenous analgesia (mean [SD], 4.2 [4.0] vs 7.1 [4.5]; P = .003), and fewer patients that required silo reduction (25 [63%] vs 48 [96%]; P < .001). Sutureless closures, compared with the sutured technique, had considerably more umbilical hernias requiring surgical repair (5 [13%] vs 0; P = .02).
Conclusions and Relevance
Sutureless repair of gastroschisis appears to be associated with a statistically significant reduction in mechanical ventilation duration and pain medication requirements but may increase umbilical hernia risk. Multicenter randomized clinical trials are necessary to determine the true advantages of the sutureless approach.
First described in 1733 by Calder,1,2 gastroschisis is a congenital paraumbilical abdominal wall defect in which the eviscerated intestines are exposed to amniotic fluid throughout gestation. In the United States, the prevalence of gastroschisis is estimated to be 3 to 4 cases per 10 000 live births, and the overall incidence appears to be increasing.3
Previously, eviscerated bowel in gastroschisis was reduced primarily immediately after birth or with a staged reduction using a silo, and the abdominal wall defect was sutured closed.4,5 The sutured closure of the abdominal wall is performed under varying tension. Increased intra-abdominal pressure is associated with inadequate ventilation and prolonged intubation.6
In 2004, the sutureless closure of the gastroschisis abdominal wall defect was introduced by Sandler et al.7 This technique uses the remnant umbilical cord to cover the abdominal wall defect, and the umbilical cord is then held in place with an overlying transparent medical dressing (Tegaderm; 3M). The sutureless closure method has the proposed advantages of lower intra-abdominal pressures after closure, limited time under mechanical ventilation, and improved cosmetic outcomes. After its introduction, the sutureless method was adopted in multiple centers, and numerous studies were conducted to compare the sutured and sutureless closure techniques. Results in retrospective studies6,8 and a clinical trial9 were inconsistent regarding the advantages of sutureless repair. Sutureless repair was shown in retrospective studies to be associated with decreased time to extubation and no difference in time to full enteral feeds or length of hospital stay. Prospective randomized clinical trial data demonstrated that sutureless repair was associated with a substantial increase in time to full enteral feeds and time to discharge.9
Because of the ambiguity in the published literature regarding the outcomes of sutured and sutureless gastroschisis closures, we sought to determine the outcomes in our institution and whether a particular technique has important advantages.
We performed a retrospective cohort review of the medical records of all consecutive patients who underwent gastroschisis repair at the University of California, San Francisco, from February 1, 2007, to April 30, 2017. This study was approved by the University of California, San Francisco Institutional Review Board. Written patient consent was obtained from parents of the neonates in this study.
Cases with incomplete data during initial hospitalization were excluded from the study. Patient-specific variables and outcome measures were extracted from the medical record. These data were length of hospital stay, days until enteral feed initiation, days until full enteral feeds, total parenteral nutrition (TPN) duration, rates of TPN cholestasis (defined as direct bilirubin level >0.117 mg/dL at >7 days of age; to convert bilirubin to micromoles per liter, multiply by 17.104), peripherally inserted central catheter duration, wound infections (defined as either positive wound cultures, wound erythema, or purulent wound drainage), antibiotic treatment duration, days until abdominal wall defect closure, days intubated, days receiving intravenous (IV) analgesia after closure, peak direct bilirubin levels, gastrostomy tube placement, presence of umbilical hernia requiring operation, bowel resections, requirement of an acid blocker or prokinetic at discharge, readmission, and mortality. We performed a separate analysis of simple gastroschisis cases (patients without intestinal atresia, perforation, or necrotizing enterocolitis).
Postoperative management in all cases was handled by the neonatal intensive care unit (NICU) team in conjunction with the pediatric surgery team. Conventional supportive therapy was provided for all patients, including initiation of TPN and nasogastric decompression. Orotracheal intubation was performed when deemed necessary by the NICU or surgical team. The gastroschisis repair method was determined by the pediatric attending surgeon managing the patient. Over the course of the study, 6 different pediatric surgeons performed gastroschisis repairs.
In the sutured closure group, repair was performed when deemed technically appropriate by the attending surgeon. Silo reduction was performed prior to closure in cases in which primary closure could not be safely achieved. Silo reduction was achieved with the use of spring-loaded silos placed at the bedside. Sutured repair was performed in the operating room (OR) under general anesthesia and consisted of fascial closure with absorbable sutures and umbilicoplasty.
In the sutureless closure group after reduction of the abdominal contents (either primarily or with a staged silo reduction), the umbilical remnant was draped over the fascial defect and reinforced with multiple skin-closure strips (Steri-Strip; 3M) to maintain the remnant in place. The remnant was covered with silver-impregnated foam dressing (Mepilex; Molnlycke Healthcare) (Figure). Sutureless closure was performed at the bedside in the NICU nursery. Dressings were typically left in place for the first 5 days and then changed twice weekly until appropriate epithelization developed.
The decision to perform sutureless or sutured repair was determined by the attending surgeon. Sutureless repair was initially performed in 2011 at our institution and became the preferred technique after 2013. Sutured repair was performed only if there was inadequate umbilical remnant (too short or desiccated) or in the setting of bowel perforation; presence of bowel atresia did not exclude a patient from sutureless closure.
After either surgical technique, the patient was monitored closely for evidence of wound infection or repair failure. Repair technique did not factor into the decision regarding initiation or advancement of feeds, which was determined on the basis of bowel function by the attending surgeon.
The χ2 or Fisher exact test was used to compare categorical variables. The Wilcoxon rank sum test was used to compare nonparametric continuous variables. Multiple grouped data were evaluated using the analysis of variance with the Tukey honest significant difference test. Univariate analysis was performed to determine the association with length of hospital stay. Variables found to be important on univariate analysis were then used in multivariate regression analysis using the linear least squares method to estimate the unknown variables within the linear regression model. Missing variables were excluded from statistical analyses. A 2-sided P < .05 was deemed statistically significant. Data are represented as mean (SD) unless otherwise specified, and CIs are reported at the 95% level. Statistical analysis was performed using JMP Pro, version 13 (SAS Institute Inc).
A total of 97 patients (47 [48%] were female and 50 [52%] were male with a mean [SD] age of 2.8 [2.8] days) underwent gastroschisis repair during the study period. Seven patients were excluded for incomplete medical records. Of the remaining 90 patients, 50 (56%) underwent traditional sutured closure and 40 (44%) underwent sutureless repair. No substantial differences were found between the 2 groups in maternal age, gestational age, delivery method, presence of intestinal atresia, or birth weight (Table 1). Age at repair was considerably older in the sutured group compared with the sutureless group (mean [SD], 4.2 [2.6] days vs 1.4 [2.3] days; P < .001), and the need for silo reduction was greater in the sutured group than in the sutureless group (48 [96%] patients vs 25 [63%]; P < .001).
No deaths occurred in the study cohort. Length of hospital stay (mean [SD] days, 43.9 [40.4] vs 36.7 [21.2]; P = .71), time to enteral feed initiation (mean [SD] days, 19.0 [14.8] vs 17.2 [12.2]; P = .16), time to full enteral feeds (mean [SD] days, 31.4 [20.2] vs 27.9 [17.3]; P = .22), TPN duration (mean [SD] days, 33.5 [29.8] vs 27.4 [18.2]; P = .23), and peripherally inserted central catheter duration (mean [SD] days, 26.0 [28.0] vs 25.4 [17.5]; P = .48) were similar between the sutured and sutureless groups (Table 2). Antibiotic duration (mean [SD] days, 7.2 [6.4] vs 12.4 [13.2]; P = .003), days intubated (mean [SD] days, 2.8 [3.3] vs 6.8 [1.3]; P = .001), and days requiring IV analgesia (mean [SD] days, 4.2 [4.0] vs 7.1 [4.5]; P = .003) were all substantially less in the sutureless group than in the sutured group. Sixteen (40%) of the 40 patients in the sutureless group did not require intubation, whereas all 50 patients in the sutured group did.
Overall rates of wound infection (14 [28%] vs 10 [25%]; P = .81), positive blood cultures (6 [12%] vs 2 [5%]; P = .29), TPN cholestasis (12 [24%] vs 8 [20%]; P = .80), adhesions requiring an operation (6 [12%] vs 5 [13%]; P > .99), development of enterocolitis (2 [5%] vs 2 [5%]; P > .99), inguinal hernia (0 vs 3 [8%]; P = .08), and readmission (5 [10%] vs 7 [18%]; P = .36) were not different between the sutured and sutureless methods (Table 3). The sutureless group did have a considerably higher rate of umbilical herniorrhaphy compared with the sutured group (5 [13%] vs 0; P = .02). The median (SD) age of umbilical herniorrhaphy was 13 (23) months. Two patients underwent hernia repair at 4 years of age and 1 at 1 month of age during an operation to correct an incarcerated inguinal hernia; 2 patients were closed at 6 and 13 months for very large fascial defects.
Multivariate regression was performed to determine which factors correlated with length of hospital stay. Presence of intestinal atresia and age at full enteral feeds were independently and statistically significantly associated with longer hospitalization (Table 4).
To better understand management practices and their evolution over the course of this study, we evaluated the number of sutureless cases performed from the study initiation on February 1, 2007, to April 30, 2017 (eFigure in the Supplement). Sutureless repairs were first performed in 2011 and became the dominant method of closure by 2013. From 2011 to 2013, personal surgeon preference determined which patients received sutured or sutureless closure. From 2013 onward, sutureless closure was used in all cases with adequate umbilical remnant for coverage unless a bowel perforation was present. Patients underwent sutured repair if they had a bowel perforation or if their umbilical remnant was too small for adequate coverage. After sutureless closure was adopted as the preferred method, the number of days intubated dropped and so did days until attempted closure. Use of IV analgesia decreased overall during the course of the study.
The sutureless approach to gastroschisis closure was introduced to lower intra-abdominal pressures associated with sutured closure, decrease operative complications, and reduce hospital costs while allowing for improved cosmetic outcomes.7 The initial sutureless repair study treated 10 patients and had no comparison to standard sutured closure. Multiple retrospective studies have been published since, but no consensus exists regarding the outcomes of each closure approach.6,8,10,11 A randomized clinical trial was performed by Brunzoni et al9 from 2009 to 2014, and its results differed from findings in retrospective studies. No difference was seen in time to extubation, and the sutureless group had increased time to full enteral feeds and mean time to discharge. The sutureless group had a trend toward substantially shorter intubation duration compared with the sutured group (mean [SD], 1.89 days [1.7] vs 3.15 days [2.37]; P = .06), but the study may have lacked adequate power because of poor enrollment (17 families refused randomization and were excluded). It is unclear why time to full enteral feeding was longer in the sutureless group, but the nonstandardized approach in silo reduction was suggested as a possible reason.
The cohort for the present study who received sutureless closure demonstrated decreased antibiotic use, a finding not seen in previous studies.6,8 However, one study did show lower infection rates after sutureless closure on multivariate analysis but not on bivariate analysis.10 We found no differences in wound infection rates but a substantial decrease in antibiotic use, which likely reflects the changes in practice patterns rather than the differences between the 2 treatment groups. In 2013, standardized antibiotic practices were implemented at our institution. Antibiotics are now used only during silo reduction unless other clinical indications are present to justify continued antibiotic coverage. Also in 2013, sutureless repair became the preferred closure technique (eFigure in the Supplement). Therefore, drawing conclusions is difficult regarding the association of gastroschisis closure technique with antibiotic duration.
In agreement with other studies, we found that patients with sutureless closures had shorter duration on mechanical ventilation. Adoption of the sutureless closure can reduce the need to intubate a portion of patients, which eliminates the need for general anesthesia and decreases the need for IV analgesia. The effects of prolonged general anesthesia on neurocognitive function early in life remain unclear, with multiple studies showing detrimental associations in preclinical models.12-14 Because of this ambiguity, sutureless repair becomes an attractive option. In our study, 16 patients in the sutureless group did not require intubation. In addition, the repair can be performed at the bedside, eliminating the risks associated with patient transfer and the cost of OR use. We did not perform a cost-benefit analysis of the 2 treatment options, but we expect that sutureless repair had reduced hospital costs given the shorter mechanical ventilation duration and no OR expense; however, future research is needed on the association between mechanical ventilation duration and OR expense. The sutureless technique may be valuable in resource-limited settings in which access to ORs and ventilators is minimal.
We found higher rates of umbilical hernias that required operative correction in the sutureless group, which has also been demonstrated in other studies.6,15 In the sutureless method, the fascial defect remains after skin closure, and an umbilical hernia is an expected outcome. However, only 13% of the patients developed umbilical hernias that were surgically repaired within the study time frame. This percentage is slightly higher than the reported prevalence of 3% to 10% at age 1 year in the general pediatric population,16 but overall it is lower than previously reported for the sutureless repair.10 In comparison, no patients in the sutured group had umbilical hernias that required an operation despite a longer follow-up period. Of the 5 umbilical repairs, 2 had delayed closure with a silo and 3 had primary closure. The morbidity associated with elective umbilical hernia repair is low16 and is considered preferable to an operation during the neonatal period.
We found no substantial difference in TPN duration, time to enteral feed initiation, and time to full enteral feeds. Enteral intolerance in gastroschisis is believed to arise from bowel inflammation and dysmotility secondary to exposure to amniotic fluid in utero.17,18 Closure technique is unlikely to be associated with differences in enteral tolerance as neither type of repair addresses the underlying problem. Our institution implemented feeding recommendations in 2013, which included the involvement of a dedicated dietitian in each case of gastroschisis and earlier initiation of enteral feeds with slow titrations of feeds. Despite these changes, no substantial difference in feeding outcomes has been observed.
The sutured closure group had more cases who had silo reduction and had an overall increased time before definitive closure. This finding may indicate a more complex disease process in the sutured closure group, but baseline clinical characteristics were not substantially different between the 2 groups, and a separate analysis of the simple gastroschisis cases showed similar results when compared with all gastroschisis cases. We believe the extended duration before closure and the higher instance of silo use in the sutured group are likely multifactorial. One factor that may be associated with the duration before closure is the need for OR time. Sutureless closures can be performed at any time of the day with limited staff, but the sutured method needs general anesthesia and a full OR team, which may have added to the time before closure in the sutured group. Surgeon preference likely played a role as well. In the sutureless closure, the fascia remains open and the overall risk of abdominal compartment syndrome is, theoretically, less. Therefore, a surgeon may be more inclined to attempt definitive closure earlier with the sutureless technique. In addition, primary closure may be more successful in a surgical strategy in which using sutureless closure is prioritized.
In 2013, our institution transitioned to primarily sutureless closures. The sutureless closure technique is used in all patients with adequate umbilical remnants who do not have bowel perforations. The sutured closure is reserved for patients whose umbilical remnant is not adequate for coverage because the cord is either short or becoming desiccated and no longer mobile enough. To avoid desiccation of the cord in delayed closures, we tuck the umbilical remnant into the abdomen during silo reduction, allowing many patients who underwent silo reductions to still have sutureless closures many days later. This preferential approach to sutureless closure may have skewed recent sutured cases to represent more complex cases of gastroschisis, but we performed a separate statistical analysis of only simple gastroschisis cases to account for this variability.
The differences in study design and the variation in the sutureless repair technique make comparing our results with results of other studies difficult. Our sutureless approach uses full-length skin-closure strips to drape the umbilical remnant over the fascial defect with an overlying absorptive dressing (Figure). We believe the use of skin-closure strips allows for an easier reapproximation of the abdominal wall defect. The sutureless closure is performed slightly differently at each institution, which makes the comparison of outcomes between centers difficult. Each institution, and even each surgeon, has nuances regarding how they performed the closure.
Because this study was retrospective and not randomized, the results are potentially biased, as sutureless repairs were performed more recently than sutured repairs (eFigure in the Supplement). Therefore, we expect our treatment groups to have undergone subtly different management in the NICU that is difficult to quantify. Despite this expectation, when evaluating days of mechanical ventilation by year, we found a sharp decrease in ventilator duration that directly coincides with the increase in sutureless cases. In comparison, IV analgesia requirements showed a slower trend downward over time and may represent changes in NICU management. Cosmetic outcomes were not specifically evaluated in the study, but anecdotally and according to another study,19 sutureless repair may be associated with excellent cosmesis.
This study appears to demonstrate that sutureless closure of gastroschisis repair achieves outcomes that are similar to sutured closure outcomes. It also may decrease the need for mechanical ventilation and IV analgesia but at the expense of an increased risk of umbilical hernias that require operative correction. To our knowledge, this is the largest retrospective study evaluating sutureless and sutured gastroschisis repair. The study is retrospective; therefore, a portion of the differences reported may reflect improvements in NICU management of gastroschisis patients over time. Multicenter randomized clinical trials are necessary to determine the advantages of the sutureless approach.
Accepted for Publication: June 2, 2018.
Corresponding Author: Lan Vu, MD, Division of Pediatric Surgery, Department of Surgery, University of California, San Francisco, 550 16th St, Fifth Floor, San Francisco, CA 94158-0570 (firstname.lastname@example.org).
Published Online: September 19, 2018. doi:10.1001/jamasurg.2018.3216
Author Contributions: Drs Vu and Witt had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Witt, Zobel, Padilla, Lee, Vu.
Acquisition, analysis, or interpretation of data: Witt, Zobel, MacKenzie, Vu.
Drafting of the manuscript: Witt, Zobel, Vu.
Critical revision of the manuscript for important intellectual content: Zobel, Padilla, Lee, MacKenzie, Vu.
Statistical analysis: Witt, Zobel.
Administrative, technical, or material support: Lee.
Supervision: Padilla, MacKenzie, Vu.
Conflict of Interest Disclosures: None reported.
Meeting Presentation: This paper was presented at the 89th Annual Meeting of the Pacific Coast Surgical Association; February 17, 2018; Napa, California.
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