Review of the Experience with Re-Operation After Laparoscopic Nissen Fundoplication

Abstract

Introduction:

The risk of redo fundoplication has been demonstrated to be significantly higher in patients of younger age, those with ongoing retching, and those who underwent more extensive dissection of the esophageal hiatus at the initial operation. The purpose of this study was to review the management and outcomes of patients who required one or more re-operations for recurrence after laparoscopic fundoplication.

Materials and Methods:

After obtaining Institutional Review Board approval, we performed a retrospective review of all patients who underwent laparoscopic Nissen fundoplication from 2000 to 2013 and subsequently required a redo operation for recurrence. Patient demographics, neurologic impairment, interval time between re-operations, operative approach, use of mesh, and length of follow-up were analyzed. Two-tailed independent Student's t test was used to compare continuous variables, and two-tailed chi-squared test with Yates's correction (Fisher's exact test where appropriate) was used for discrete variables.

Results:

Eighty-two patients (10.3% of the sample) required re-operation during the study period. The mean age at initial surgery was 1.8 ± 3.6 years. Fifteen patients (18.3%) required more than one re-operation. Of the 102 re-operations performed, 68 were successfully managed laparoscopically, 3 required conversion to an open procedure, and 31 were performed open from the outset. Of those patients requiring more than one re-operation, there was no difference in age, weight, use of mesh, or time to subsequent re-operations compared with patients that only required one redo fundoplication.

Conclusions:

The incidence of patients requiring another operation after a redo operation after an initial laparoscopic fundoplication is 18%. Patient demographics and time to re-operation have not been found to be predictive of which patient will require multiple re-operations for recurrence. However, younger patients and those with a shorter time to re-operation may increase the likelihood of failure.

Introduction

Laparoscopic Nissen fundoplication for management of gastroesophageal reflux and its associated sequelae in infants and children is a fairly common procedure for a pediatric surgeon.^1,2 The laparoscopic technique is generally accepted to be as safe and efficacious as an open procedure in all pediatric age groups.^3–5 Risk for failure requiring re-operation has been demonstrated in patients of younger age, symptoms of ongoing retching postoperatively, and more extensive dissection of the esophageal hiatus at the initial operation.^6,7 However, there are limited data regarding outcomes of patients requiring at least one re-operation for recurrence. The aim of this study was to review the management and outcomes of patients who required one or more re-operations for recurrence after an initial laparoscopic Nissen fundoplication.

Materials and Methods

After obtaining Institutional Review Board approval, we performed a retrospective review of all patients who underwent laparoscopic Nissen fundoplication from 2000 to 2013. Only patients requiring re-operation for recurrence were included in the study—this included any patient who underwent re-operation for hiatal hernia repair, paraesophageal hernia repair, and/or redo of the fundoplication wrap. Patients whose initial operation was not performed laparoscopically, were deceased, or had insufficient data were excluded from the study. Data collected included patient demographics, associated diagnoses, concurrent procedures, and operative details, as well as length of time to recurrence and follow-up. Two-tailed independent Student's t test was used to compare continuous variables, and two-tailed chi-squared test with Yates's correction where appropriate was used for discrete variables.

Results

In total, 796 patients underwent antireflux surgery during the study period. Of these patients, 93 were identified as requiring re-operation, and 82 met inclusion study criteria. Four patients were excluded secondary to insufficient available data, 6 were excluded given the initial operation not performed laparoscopically, and 1 was excluded because the initial operation was a Boix–Ochoa fundoplication.

Of the 82 patients who met inclusion criteria, 55 (67%) were male, and 30 were identified as having some degree of neurologic impairment. Mean age and weight of patients at initial operation were 1.8 ± 3.6 years and 10.1 ± 13.6 kg, respectively, with the average time to first re-operation for recurrence being 2.4 ± 2.5 years. There was a median follow-up of 4.3 years (range, 0.5–11.1 years) from the time of initial operation to last surgical evaluation.

Fifteen patients (18%) required more than one re-operation in the study period. Of these patients, 12 required two re-operations, two required three re-operations, and one required five re-operations for recurrence, for a total of 35 re-operations. This accounted for 34% of the 102 total re-operations performed.

A biologic mesh (porcine dermal collagen, porcine small intestinal submucosa, or acellular cadaveric dermis) was placed in 37 (45%) patients at the time of the first re-operation, of whom 6 (16%) required subsequent re-operation for recurrence. Of the 45 patients who did not have mesh placed at time of first re-operation, 9 (20%) required subsequent re-operation. Mesh was usually placed because of a hiatal hernia with transmigration of the wrap across the diaphragm.

As can be seen in Table 1, when comparing those patients who only required one re-operation with those who required multiple surgeries, there was no significant difference in gender, neurologic impairment, symptoms of postoperative retching, time to first re-operation, or height and weight at the initial operation and first re-operation.

Table 1.

Patient Demographics Comparing Patients Undergoing One Versus Multiple Re-Operations

	Patients requiring
	One re-operation (n = 67)	Multiple re-operations (n = 15)	P value
Total number of re-operations	67	35	NA
Gender (male)	44	11	.7
Neurologic impairment	25	5	1
Postoperative retching	6	2	.6
Age (years) at initial operation	2.0 ± 3.9	0.9 ± 1.2	.2
Weight at initial operation (kg)	11.1 ± 14.9	6.1 ± 2.5	.2
Age (years) at first re-operation	4.5 ± 4.6	2.3 ± 2.4	.07
Time (years) to first re-operation	2.6 ± 2.6	1.5 ± 1.3	.11

NA, not applicable.

As expected, the mean operative time of 1.5 ± 0.5 hours at initial operation was significantly shorter than the operative time of 2.8 ± 1.0 hours at first re-operation (P < .01). However, there was no significant difference in operative time when comparing patients who underwent one re-operation (1.6 ± 0.5 hours at initial and 2.7 ± 0.7 hours at first re-do) and patients who underwent multiple re-operations (1.3 ± 0.4 hours at initial and 2.6 ± 0.9 hours at first re-do) with P values of .07 and .6, respectively.

As can be seen in Table 2, when comparing the patients who underwent one versus multiple re-operations, there was no significant difference in associated procedures, including number of patients who underwent gastrostomy at the initial operation or concomitant pyloroplasty at first re-operation. Fifteen patients required esophageal dilations over the study time period for a total of 38 dilations. There was no significant difference (P = .14) in the number of patients requiring dilations between those who only required one re-operation (n = 10) and those who required multiple re-operations (n = 5). In total, 19 dilations were required in each group.

Table 2.

Associated Procedures of Patients Undergoing One Versus Multiple Re-Operations

	Patients requiring
	One re-operation (n = 67)	Multiple re-operations (n = 15)	P value
Gastrostomy at first operation	34	8	1
Pyloroplasty at first re-operation	13	3	1
Esophageal dilations	10	5	.1

Over the period of this retrospective review, there was a change in operative technique after completion of a randomized study from 2006 to 2008 demonstrating a significant decrease in wrap transmigration with minimal dissection of the esophageal hiatus.⁷ Using 2009 as a marker for when the operative technique was changed, several differences were noted between the two groups.

In total, 512 patients underwent Nissen fundoplication prior to 2009, of whom 70 (13.7%) required re-operation, compared with 12 (4.2%) of 284 patients after 2009. This was a significant decrease (P < .01) in incidence of re-operation after 2009. There was also a significant change in indication for re-operation after the change in operative technique.

As shown in Table 3, prior to the change in surgical technique, wrap transmigration as the primary indication for re-operation was significantly higher prior to 2009 (P < .01). Also, prior to 2009 there were four emergency re-operations (for gastric volvulus, strangulated colon, gastric perforation, and incarcerated paraesophageal hernia), of which there was none after 2009. After transitioning to minimal esophageal dissection at the time of initial fundoplication, the occurrence of wrap disruption as the primary reason for recurrent reflux and re-operation became significantly higher.

Table 3.

Comparison of Patients Prior to and After Change in Surgical Technique

	Initial surgery
	Prior to 2009 (n = 512)	After 2009 (n = 284)	P value
Patients requiring re-operation	70 (13.7%)	12 (4.2%)	<.01
Indications for re-operation
Wrap transmigration	55 (78.5%)	4 (33.3%)	<.01
Wrap disruption	4 (5.7%)	6 (50%)	<.01
Recurrent reflux symptoms	1 (1.4%)	2 (16.6%)	.06
Emergency conditions	4 (5.7%)	0	1.0
Time (years) to first re-operation	2.5 ± 2.6	1.7 ± 1.4	.3
Patients with >1 re-operation	13	2	1
Mesh at first re-operation	33	4	.5

Discussion

The incidence of re-operation after an initial laparoscopic Nissen fundoplication in this single-center cohort was 10.3%. Of those patients who required re-operation, 82% were cured with only one re-do procedure, with mean time to re-operation of 2.4 years, and mean time to second re-operation of 1.3 years.

The incidence of re-operation in our study is similar to that in other retrospective reviews reporting a rate ranging from 7.2% to 13.2%.^8–11 Our mean time to first re-operation of 2.4 years also falls within the reported literature in pediatric patients, with the mean ranging from 2.3 to 2.8 years.^6,12

In past studies neurologic impairment has been reported as associated with a higher incidence of failure of antireflux operations. In one retrospective review of 234 patients, neurologically impaired patients were significantly more likely to require re-operation than neurologically normal patients (19% versus 5%).¹³ In another retrospective review of 81 patients undergoing redo Nissen fundoplication, neurologic impairment was determined to be a significant predictor of failure.¹⁴ However, the relationship between neurologic impairment and recurrence rates is not always evident; other studies have shown that neurologic impairment alone does not necessarily increase the risk of developing recurrence.¹⁵ In a retrospective review of 823 patients, neurologic impairment was not identified as an independent predictor of the need for re-operation.⁶ In a prospective randomized trial comparing two types of hiatal dissection in which the randomization was stratified for neurologic impairment under the assumption of worse outcomes for these patients, there was no difference in the need for redo fundoplication between neurologically normal and abnormal children.⁷ When looking specifically at our cohort of patients who have undergone at least one re-operation for recurrence, neurologic impairment was not an independent risk factor of failure after one redo surgery.

A younger age at the time of initial operation has been demonstrated to be a factor associated with the need for re-operation in a larger dataset than presented here.⁶ In our study the patients requiring redo fundoplication were half the age, on average, than the others, albeit the difference was not significant in this small sample. The patients who failed the first redo were also about half the age of those who did not (2.3 versus 4.5 years), which approached significance with a P value of .07 despite the small numbers. This suggests that a younger age at the time of first operation and a shorter time to first recurrence may be associated with a higher likelihood of failure.

The use of biosynthetic mesh for reinforcement of the muscular crural closure in patients needing hiatal hernia repair, as well as reinforcement after an initial laparoscopic Nissen fundoplication and or at the time of redo Nissen fundoplication, has been demonstrated to reduce the risk of recurrence.^16–18 Although this study did not demonstrate a difference in success based on mesh placement, this is likely due to the reason for the redo fundoplication. Prior to 2009 most redo operations were to repair herniation of the wrap, and during this era we found mesh improved success of first redo.¹⁸ After we began leaving the phrenoesphageal membrane intact at the first operation,⁷ the need for a redo operation decreased, and the reason was usually wrap loosening, not herniation. Therefore, the redo fundoplications in the last portion of this series did not get mesh because there was no need for the mesh. We still recommend mesh placement when the indication for re-operation is wrap transmigration.

In conclusion, over time, there has been a significant decrease in recurrence requiring re-operation secondary to a change in operative technique. With this change in technique, there has also been a change in indication for re-operation, with a trend away from wrap transmigration to disruption of the wrap. The incidence of patients requiring re-operation after one redo is 18%. Younger patients and those with a shorter time to re-operation may increase the likelihood of failure.

Footnotes

Disclosure Statement

No competing financial interests exist.

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