Abstract
Background:
Malrotation is a common congenital anomaly that can lead to bowel obstruction and ischemia if not corrected with a Ladd procedure. Controversy exists between open and laparoscopic approaches. We sought to compare postoperative outcomes and determine risk factors for conversion to an open procedure.
Methods:
The National Surgical Quality Improvement Program (NSQIP)-Pediatric was used to identify patients undergoing Ladd procedures from 2013 to 2018. Propensity score matching was used to account for differences in patient characteristics between open and laparoscopically treated cohorts. Chi-square tests and adjusted logistic regression analysis were used to determine patient outcomes differences between treatment groups and factors associated with conversion.
Results:
A total of 2437 patients were identified, 1889 (77.5%) open, 548 (22.5%) laparoscopic, and 193 (35.2%) laparoscopic converted to open. Patients undergoing laparoscopic compared with open procedures had shorter length of stay (5 versus 7 days, P < .001) and lower overall complication rates (13.1% versus 18.1%, P = .025), despite longer operative times (108.9 versus 93.7 minutes, P < .001). Patients requiring conversion were more likely to be younger, have an urgent/emergent case, sepsis/septic shock, and nutritional support requirement.
Conclusions:
After risk adjustment, laparoscopic Ladd procedure is associated with decreased complications and minimal operative time increases compared with an open approach. Risk factors associated with conversion should be considered during operative planning.
Introduction
Malrotation is a congenital malformation that occurs in 1 in 500 live births.1,2 Although often clinically asymptomatic, it can lead to obstruction, poor feeding tolerance, and intestinal ischemia in the setting of midgut volvulus. 3 Standard treatment for malrotation is surgical correction with the Ladd procedure—detorsion of the bowel (in the case of volvulus), lysis of peritoneal bands, widening of the mesentery and reorientation of the colon and small bowel with the cecum in the abdomen's left upper quadrant, and appendectomy.1,4 However, controversy exists between choice of open versus laparoscopic approach.1,5
The original laparoscopic technique for the Ladd procedure was developed in 1995 and reported by van der Zee et al. to provide the benefits of smaller incisions (and better cosmesis), improved pain control, and shorter hospitalization, which is supported by recent literature. 6 However, this approach has been criticized for it associated concerns of increased operative times, theoretical recurrent volvulus, and potential need for conversion to an open procedure. 5 In fact, anywhere from 8% to 33% of laparoscopic Ladd procedures are converted to open, with higher rates in younger patient populations.5,7–10 Therefore, this technique tends to be favored for use in stable older children presenting without signs or symptoms of volvulus. Nevertheless, controversy over the best approach persists.1,5,10–12
Therefore, we sought to evaluate the safety and outcomes associated with the Ladd procedure using the National Surgical Quality Improvement Program Pediatric (NSQIP-P) database. Our goals included characterizing the patient cohorts most typical of each procedure type, compare outcomes for laparoscopic versus open approach in propensity matched cohorts, and determine the main risk factors for patients who require conversion from laparoscopic to open procedures.
Materials and Methods
Data source
The American College of Surgeons (ACS) NSQIP-P database was used. NSQIP-P is a nationally validated program that uses certified clinical abstractors to prospectively collect detailed clinical data from the preoperative through the 30-day postoperative phases experienced by pediatric surgical patients in the United States. 13 Approval for the use of the NSQIP-P data was obtained from the institutional review board of Rush University Medical Center and NSQIP-P. This project was deemed non-human subject research and received an IRB waiver.
All pediatric patients ages 0–18 in the NSQIP-P database who underwent a Ladd Procedure (identified by CPT code 44055) over 2013–2018 were included in this study. Patients were then categorized based on whether or not they had a laparoscopic, open, or laparoscopic converted to open procedure (defined as laparoscopic and open in NSQIP-P) using the variable “LAPTHOR.”
Primary and secondary outcomes
The primary outcomes for our study included morbidity, mortality, operative times, and length of stay between patients undergoing a laparoscopic versus open Ladd procedures. In this comparison, patients whose procedure started laparoscopically remained in the laparoscopic group. In a separate analysis, we compared patients undergoing fully laparoscopic versus laparoscopic-converted to open (LCO) procedures. For both analyses, morbidities were defined as wound complication (which included superficial infection, wound infection, deep incisional infection, organ/space infection, and wound disruption), respiratory complication (which included pneumonia and reintubation), renal complication (which included progressive renal insufficiency, acute renal failure, and urinary tract infection), neurological complication (which was defined as stroke/cerebrovascular accident with neurological deficit), bleeding requiring transfusion, and systemic sepsis/septic shock. Mortality was defined as death within 30 days of surgery.
The secondary outcomes for our study included determining which morbidities were most common and significant within the patient cohorts. We also explored the preoperative patient characteristics of our LCO group that put them at risk for conversion. The specific characteristics of interest were as follows: age, wound class, American Society of Anesthesiologists' (ASA) classification of Physical Health, history of CNS disease, case type (elective versus emergent, versus urgent), neurological risk factors (which included neuromuscular disease and seizures), cardiac risk factors (which included previous cardiac surgery and minor, major, and severe cardiac risk factors), pulmonary risk factors (which included ventilator requirement, oxygen requirement, tracheostomy, asthma, and structural pulmonary/airway abnormality), hematologic disorder, use of preoperative inotropic support, steroid use, nutritional support, preoperative sepsis/septic shock, and volvulus.
Statistical analysis
Propensity matching based on age, gender, ASA class, case type (elective, emergent, or urgent), and presence of volvulus was used to compare the laparoscopic with open patient cohorts. Chi-square tests and Fisher exact tests, when appropriate, were used to determine significant differences in patient characteristics among laparoscopic versus open Ladd procedure patients. Univariate chi-square tests and Fisher exact test were used, when appropriate, to compare the laparoscopic with LCO patient cohorts. Adjusted multivariable logistic regression modeling with likelihood ratio tests were then conducted using significant variables on univariable analysis, to determine risk factors for conversion from laparoscopic to open Ladd procedure. All analyses were performed using SAS 9.4 (Cary, NC).
Results
Patient characteristics and perioperative data
Our NSQIP-P database review found 2437 patients who underwent a Ladd procedure, 1889 (77.5%) open, 548 (22.5%) laparoscopic, and 193 (35.2%) of the laparoscopic cohort required conversion to open. Characteristics of patients undergoing open versus laparoscopic or laparoscopic converted to open cases are summarized in Table 1. Significantly different factors included younger age, having cardiac risk factors, dirtier wound class, higher ASA class, urgent/emergent case type, preoperative diagnosis of volvulus, shorter anesthesia and operative times, and need for nutritional support before surgery in the open procedure cohort. After propensity score matching, 548 open and 548 laparoscopic cases were examined. Patient characteristics are summarized in Table 2. Patients undergoing open procedure were observed to have significantly shorter anesthesia and operative times. Characteristics of patients undergoing laparoscopic versus LCO cases are summarized in Table 3. Significantly different factors in the LCO cohort included younger age, presence of hematologic disorder, preoperative sepsis/septic shock, urgent/emergent case type, and need for nutritional support.
Characteristics of Patients Undergoing Laparoscopic Versus Open Ladd Procedures Before Propensity-Matched Analysis
ASA, American Society of Anesthesiologists; IQR, interquartile range; N/A, not applicable; SD, standard deviation.
Characteristics of Patients Undergoing Laparoscopic Versus Open Ladd Procedures After Propensity Matching for Age, Gender, American Society of Anesthesiologists Class, Case Type, and Volvulus
ASA, American Society of Anesthesiologists; IQR, interquartile range; N/A, not applicable; SD, standard deviation.
Characteristics of Patients Undergoing Laparoscopic Versus Laparoscopic Converted to Open Ladd Procedures
ASA, American Society of Anesthesiologists; IQR, interquartile range; N/A, not applicable; SD, standard deviation.
Propensity score-matched open versus laparoscopic Ladd procedure patient outcomes
The primary outcomes examined included all-cause morbidity, 30-day mortality, and length of stay (Table 4). Patients undergoing open procedures had significantly higher risk of morbidity 18.1% versus 13.1% (P = .025) with an adjusted odds ratio (OR) of 1.46 (95% confidence interval [CI]: 1.05–2.03). Respiratory complications were significantly more common in the open group compared with the laparoscopic group (5.1% versus 2%, P = .006). The method of operation did not affect mortality. The length of stay was significantly longer in the open procedure patient cohort than the laparoscopic (median 7 versus 5 days P < .001).
Surgical Morbidities and Mortality for Patients Undergoing Laparoscopic Versus Open Ladd Procedures After Propensity Matching for Age, Gender, American Society of Anesthesiologists Class, Case Type, and Volvulus
Significant values are in bold.
IQR, interquartile range.
Laparoscopic versus laparoscopic converted to open Ladd procedure patient outcomes
We also compared all-cause morbidity, mortality, and length of stay in patients who underwent laparoscopic versus LCO procedures (Table 5). Patients undergoing LCO had significantly higher risk of morbidity 20.7% versus 9.0% (P < .001) with unadjusted OR of 2.64 (95% CI: 1.6–4.4) compared with the laparoscopic surgery cohort. However, this OR decreased to 1.73 (95% CI: 0.976–3.062, P = .060) in our adjusted model. Converted cases were associated with more bleeding requiring transfusion, wound complications, and sepsis/septic shock. Requirement for conversion did not affect mortality. Length of stay (median 9 versus 4 days P < .001) and operative times (126.6 versus 99.3 minutes, P < .001) were significantly longer in the LCO cohort. Overall, younger age, nutritional support, preoperative sepsis/septic shock, and urgent/emergent cases were associated with increased risk of conversion to open procedures (Fig. 1).
Adjusted OR and 95% CI for risk factors for conversion from laparoscopic to open Ladd procedure. CI, confidence interval; OR, odds ratio.
Surgical Morbidities and Mortality for Patients Undergoing Laparoscopic Versus Laparoscopic Converted to Open Ladd Procedures
Significant values are given in bold.
IQR, interquartile range.
Discussion
The Ladd procedure is a widely adopted technique for the surgical management of intestinal malrotation; however, debate remains as to whether this procedure should be performed open or laparoscopically.1,5,10–12 In our propensity score-matched comparison, we found that a laparoscopic Ladd procedure was associated with decreased morbidity and equivocal mortality to those who had an open procedure, suggesting it is a safe alternative to open surgery in the appropriate patient population. As laparoscopy is being increasingly used, we also sought to identify risk factors for conversion and the impact of conversion to open on patient outcomes. We found that urgent/emergent procedures, preoperative sepsis, and preoperative nutritional support all increased the odds of conversion, and that converted procedures led to increased morbidity but no difference in mortality. These findings may assist surgeons in perioperative planning and patient selection for each approach.
Consistent with previous studies, we found that laparoscopy is a safe approach to the Ladd procedure and leads to less morbidity and shorter length of stay, although longer operative times. 5 To our knowledge, this is the largest retrospective analysis of laparoscopic versus open Ladd procedures, and the first database review to use intention-to-treat analysis. However, these findings should be interpreted in the context of the patient population evaluated. The nonpropensity-matched cohort of patients undergoing open procedures were significantly younger, more likely to have urgent or emergent cases, higher ASA class, and volvulus. In this study, we used propensity matching to account for these differences.
Several factors may influence the practical applications of this study such as age, emergent case status, and volvulus. Because propensity matching resulted in an increased average age of patients, laparoscopy most accurately resulted in improved outcomes for patients who are at postinfancy. Although urgent and emergent cases and patients with volvulus would intuitively seem to result in more complications, propensity matching allowed for adequate adjustment and demonstrated improved outcomes in patients undergoing laparoscopic Ladd procedures even in emergent cases or cases with volvulus. Nevertheless, surgical approach should still be tailored to individual patient needs, clinical acuity, and surgeon discretion. In the nonpropensity-matched-adjusted logistic regression analysis, urgent and emergent cases do increase the odds of conversion from laparoscopic to open procedures and have higher rates of morbidity. Therefore, making definitive recommendations regarding the optimal surgical approach in these patient populations is beyond the scope of this study and warrants further investigation.
Unlike previous studies, we found that a laparoscopic approach was associated with significantly fewer overall postoperative complications (prior work demonstrated noninferiority) and that an open approach was associated with significantly more respiratory complications. It is possible that as pediatric surgical centers became more facile and experienced with the laparoscopic approach, the overall complications rates decreased. More likely, the large size of our sample provided enough power to detect the differences in morbidity between the two groups. Furthermore, previous work has suggested that less trauma to the abdominal wall during laparoscopic surgery may be a possible protective factor against respiratory complications. 14
Both decreased morbidity and shorter LOS are significant positive outcomes of patients who underwent laparoscopic Ladd procedures. However, the cost of increased mean operative times is not negligible. The finding of longer duration of surgery with shorter hospitalization has been demonstrated within many different laparoscopic pediatric surgeries including appendectomy, pyloromyotomy, and cholecystectomy. It is often the case that this tradeoff decreases expenditures without effecting safety.15–18
Another novel aspect of our study was the examination of patients who had LCO procedures and the identification of risk factors for conversion. Prior studies have shown that LCO results in longer procedures, longer hospital stays, and higher morbidities.10,11 This was corroborated in our study, with the most significant morbidities being wound complications, sepsis, and blood transfusion requirements. Moreover, in this study, the rate of conversion was 35.4%, which is the highest rate in the published pediatric literature.1,5,8,9 As laparoscopy is becoming more popular, it is not without risk as the ramifications of conversion are not trivial. 18 Finally, in our adjusted multivariable analysis, we identified younger age, urgent cases, preoperative nutritional supplementation, and preoperative sepsis as risk factors for conversion from laparoscopic to open procedures. Unfortunately, none of these factors are modifiable, but should be considered during perioperative planning.
Limitations to this study include those inherit to the retrospective design and factors associated with the NSQIP-P database. Although propensity matching helps improve comparisons between the laparoscopic and open groups, this led to an increased mean age of patients in the open surgery cohort compared with that cited in the literature. Prospective and randomized control trials would allow for a more direct comparison. Increased granularity of data on the severity of malrotation and intraoperative findings could also lend insight into surgeon decision-making and reasons for conversion to an open procedure. NSQIP-P is limited to assessing 30-day perioperative outcomes and may not capture all postoperative complications, morbidities or mortalities, or potential recurrences. A major cited advantage of an open Ladd procedure is formation of adhesions to decrease recurrence. 5 Finally, submission of data to the NSQIP-P is voluntary and organizations that participate are often larger volume, academic medical centers that may not be representative of all hospitals that provide pediatric care for malrotation.
In conclusion, after risk-adjustment, laparoscopic Ladd procedure is associated with decreased complications and minimal operative time increases compared with an open approach. Younger age, preoperative nutritional support, preoperative sepsis, and urgent/emergent cases are risk factors associated with conversion from laparoscopic to open Ladd procedure and should be considered during operative planning.
Footnotes
Disclosure Statement
The American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.
No competing financial interests exist.
Funding Information
No funding was received for this work.