Long-Term Outcome of Laparoscopic Nissen Procedure in Pediatric Patients with Gastroesophageal Reflux Disease Measured Using the Modified QPSG Roma III European Society for Pediatric Gastroenterology Hepatology and Nutrition's Questionnaire

Introduction

For children with symptomatic gastroesophageal reflux disease (GERD) who are refractory to medical therapy, an antireflux procedure is generally recommended as the treatment of choice.^1–3 Several studies have documented the effectiveness of fundoplication in controlling GERD.^4,5 Currently, fundoplication is one of the most common operations performed in children by pediatric surgeons in the United States.^3,6 Among the various antireflux operations, the Nissen fundoplication is the most widely used procedure in infants and children.^7,8 Since the laparoscopic fundoplication (LF) procedure was first described in children in 1993, this technique has been reported by a large number of centers, and the number of procedures performed for GERD is increasing worldwide.^8,9 Laparoscopic antireflux procedure (LARP), as reported in the international literature, represents the gold standard for surgical treatment for pediatric patients with GERD.^1,10 However, there are a few reports in literature about the long-term outcome of pediatric patients who had undergone LARP and in general, the majority of follow-ups stops 5 years after the procedure.^11,12 In general, follow-up consists of some complementary exams (pH-monitoring, endoscopy, barium swallow, and manometry) that are usually not well tolerated by children and their families.^13,14 This study has been planned after a discussion with our gastroenterologists about the best way of performing a longer follow-up for our patients who had been operated on for GERD by using LF. For this reason, we adopted a questionnaire created by European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and modified by our group as for postsurgical follow-up.^15,16 The purpose of our study is to analyze the long-term results in patients who have undergone laparoscopic Nissen fundoplication by using a modified Questionnaire on Pediatric Gastrointestinal Symptoms (QPSG) Roma III ESPGHAN questionnaire.

Materials and Methods

We report the results about long-term outcome of patients who have undergone laparoscopic Nissen fundoplication from January to December 1998, with a follow-up longer than 10 years (range 11–12 years).

All patients were operated by the same surgeon and underwent the same surgical technique. The age of patients varied from 5 months to 16 years (58 months on average). The average weight was 20 kg (range, 5–65 kg). All the children underwent a complete preoperative work-up (pH-monitoring, endoscopy, barim swallow, and manometry), and all had well-documented GERD. As for the technical point of view, in all patients, the crura were posteriorly closed by one or two separated stitches, the Nissen valve was then fixed to the right crura by means of two separated stitches, and short gastrics were never divided in our patients. More technical details (patients' position, trocars, and technique) had been already reported by our group in a previous article (see ref. ⁸ ). All the patients were neurologically normal, and only 2 patients in our series had a mild neurological impairment, as they both had a percutaneous endoscopic gastrostomy (PEG). These 2 patients were considered with a mild neurological impairment, because they had mental retardation and GER, but they walked by themselves and could also eat by themselves. All patients were contacted by phone, and they underwent the modified questionnaire QPSG Roma III of the ESPGHAN, modified by our group as for postsurgical follow-up. Patients were then invited to have a clinical follow-up in our hospital. All 36 patients were in good condition; however, only 22 (61%) out of 36 patients accepted to undergo a follow-up in a day hospital setting (11 boys and 7 girls), with an average age of 16.2 years. Of the remaining 14 patients, 10 (28%) answered by phone that they were in a good condition, completely recovered from reflux, and for this reason, they considered it unnecessary to have another hospital follow-up, but accepted to undergo a telephonic questionnaire. The remaining 4 refused to be checked, because they were “too busy” to be checked. Our study focuses only on the follow-up of 32 patients. In 22 out of 32 (69%) patients, clinically controlled, the appearance of trocars scars was evaluated by using scar assessment scale. All 32 patients underwent the questionnaire QPSG Roma III of the ESPGHAN modified by our group, and the patients'weight was analyzed. The questionnaire consisted of four pages; the patients had to answer several questions about their clinical conditions after the procedure, with particular attention to the presence of abdominal pain, belching, choking, vomiting, dysphagia, and possible use of antacids or proton pump inhibitors (PPI). The interview time was about 20 minutes for each patient.

Results

All the patients analyzed in this series had a follow-up longer than 10 years.

Twenty-eight (87.5%) out of the 32 patients interviewed considered themselves completely recovered from reflux. Those data were also confirmed by complementary examinations (barium swallow, pH-metry, manometry, and endoscopy) that they had undergone at the 5-year follow-up after the operation. Four out of 32 patients (12.5%) had a mild persistent GER treated sometimes by pharmacological therapy with antiacid drugs. These 4 patients underwent a barium swallow that was normal, and a pH-monitoring with a reflux time ranged from 4.5% to 5%. Nine out of 32 patients (28%) still referred to sometimes have a mild dysphagia for some solid food. When compared with a 5-year follow-up when this symptom was present in 49% of patients, dysphagia improved in the next 5 years. For none of these patients, a postoperative esophageal dilation was necessary. In these 9 cases, we performed a barium swallow that showed a nondilated esophagus with a normal passage of contrast into the stomach. Twenty-one out of 32 (66%) patients could burp, and only 9 out of 32 (28%) patients could vomit. These parameters are important, because they show that in 66% of the patients a normal physiology of the esophago-gastric junction is maintained. The cosmetic aspect was evaluated only in 22 patients who had accepted the clinical control, and it was good in 20 out of 22 (91%) patients. In particular, the umbilical scar was never visible in all the patients, and trocar's scar was excellent in all the patients. The weight/height ratio according to the age, measured by using body mass index table for children, was satisfactory in 30 out of 32 (94%) patients. As for the quality of life, it was considered good or optimal in 28 out of 32 (87.5%) patients. In addition, the 2 patients who presented a persistent mild GER (already present at the 5-year follow-up) were satisfied with the procedure, because only sometimes they used antiacid drugs, compared with the preoperative period in which they had been PPI dependent, because antiacids had no effect during their preoperative period. No patient showed respiratory symptoms after surgery. None of the interviewed patients reported symptoms that could be attributed to the gas bloat or dumping syndrome. Results are summed up in Table 1.

Discussion

Several reports have demonstrated that LFs can be safely and effectively performed in adult patients with lower morbidity and fewer complications than those typically seen in the traditional open approach.^17,18

Data concerning the long-term outcome of LF in pediatric patients are still scarce, because the majority of the reports are focused on a short- or medium-term follow-up. ¹²

In addition, the follow-up usually consists of several instrumental exams that are not well tolerated by children and their families.^13,19

As reported in a previous article, after antireflux surgery, we usually stopped the follow-up 5 years after surgery, when we performed a complete instrumental follow-up. ⁸

The main characteristic of our study is that we have analyzed the data of our patients with a follow-up longer than 10 years after surgery.

We think that it is mandatory to have a follow-up longer than 10 years, because, as Pashankar reports in his experience, recurrence of reflux symptoms occurs on average at 4.9 years (range, 0.6–13 years) after fundoplication.^20,21

The results of this study show that laparoscopic Nissen fundoplication is highly successful in providing symptomatic relief to patients operated on for GERD with a long-term follow-up. ¹⁰

We think that our study is important for two main reasons: the first one is that we have a 10-year follow-up; the second is that we have analyzed the results through a questionnaire without using complex and not tolerated complementary exams such as endoscopy, barium swallow, or pH-monitoring.

As for the first point, in general, in pediatric literature, long-term results are rarely reported, because it is difficult to follow patients in adult age.^22,23 In fact, even if we were lucky to contact all the patients by phone, then 50% of them would refuse to undergo a clinical follow-up at the hospital.

We think that with a follow-up longer than 10 years, we can follow the patients after puberty and in adult age after the complete development of their body. For this reason, we assume that if patients are in a good condition 10 years after the operation, then they have probably completely recovered as long as they live.^17,24

We think that using a questionnaire to check the results of the operation is useful; in fact, all the patients prefer to avoid repeating instrumental controls (pH-monitoring, endoscopy, manometry, and barium swallow), because they consider these exams painful and uncomfortable.^25,26

Thanks to the precious help of our pediatric gastroenterologists, we have the possibility of adopting the questionnaire QPSG Roma III of the ESPGHAN.^15,16 However, as previously reported, we have modified the questionnaire, because the form was created to perform a clinical and not a surgical follow-up.

We assume that probably the ESPGHAN questionnaire can be used as a routine to check the patients' results after surgery, and complementary exams have to be performed only in case of problems or in symptomatic patients, as happened only in our series.^27,28

Analyzing the results point by point, we had excellent cosmetics results in 91% of patients. ²⁹ Three patients presented hyperchromic scars. They were all operated between May and July, and they forgot to use a complete solar protection on trocars scars, which when exposed to the sun without protection became hyperchromic. We suggest all our patients operated before summer to use a complete solar protection on trocars scars for at least 2 months after surgery. In addition, weight/height ratio was excellent in 94% of patients, considering that the 2 patients showing a poor result were neurologically impaired patients with a PEG. As for symptoms, 87.5% of patients were symptoms free, and they had completely recovered. Only 2 brothers older than 18 years presented a persistent mild GER treated only sometimes with antiacids drugs. Before surgery, both brothers were PPI dependent, and although sometimes they took antiacids drugs, they were satisfied by the results of the operation, and after Ph-monitoring and barium swallow, they needed no further treatment. Dysphagia was still present in 28% of cases. In all cases, there was a light and occasional dysphagia for some solid food. Barium swallow performed in these 5 cases showed no stenosis or other problems and for this reason, they underwent no further treatment. According to the pre-existing literature, dysphagia can be present in 1 out of 3 patients, but none of our patients required therapy for this problem.^30,31,32

As for physiological results of GE junction after Nissen procedure, in our series, 66% of the patients can burp and probably for this reason in our series, we report no episodes of gas bloat or dumping syndrome. On the contrary, only 28% of patients can vomit. This aspect can present a problem only in the case of gastroenteritis, when vomit is one of the defense mechanisms of our body.^1,31,32

Another important point to underline is that no patient in our series required further treatment or redo surgery.

Our experience shows that the long-term follow-up of patients operated on for GERD by using the Nissen laparoscopic procedure shows a good clinical result and a good or optimal quality of life ten years after LF. The modified questionnaire QPSG Roma III of the ESPGHAN seems to be an effective way of checking the long-term results, because it is easy to use and avoids submitting patients to long and not well tolerated instrumental exams.