Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial.

BACKGROUND: Randomized controlled trials (RCT) comparing long-term outcome after laparoscopic (LF) and open fundoplication (OF) in children are lacking. Here we report recurrence rates and time to recurrence, frequency of re-interventions, use of antisecretory drugs, gastrointestinal symptoms, and patient/parental satisfaction a decade after children were randomized to LF or OF. METHODS: Cross-sectional long-term follow-up study of a two-center RCT that included patients during 2003-2009. Patients/parents were interviewed and medical charts reviewed for any events that might be related to the fundoplication. If suspicion of recurrence, further diagnostics were performed. Informed consent and ethical approval were obtained. CLINICALTRIALS: gov: NCT01551134. RESULTS: Eighty-eight children, 56 (64%) boys, were randomized (LF 44, OF 44) at median 4.4 [interquartile range (IQR) 2.0-8.9] years. 46 (52%) had neurological impairment. Three were lost to follow-up before first scheduled control. Recurrence was significantly more frequent after LF (24/43, 56%) than after OF (13/42, 31%, p = 0.004). Median time to recurrence was 1.0 [IQR 0.3-2.2] and 5.1 [IQR 1.5-9.3] years after LF and OF, respectively. Eight (19%) underwent redo fundoplication after LF and three (7%) after OF (p = 0.094). Seventy patients/parents were interviewed median 11.9 [IQR 9.9-12.8] years postoperatively. Among these, use of anti-secretory drugs was significantly decreased from preoperatively after both LF (94% vs. 35%, p < 0.001) and OF (97% vs. 19%, p < 0.001). Regurgitation/vomiting were observed in 6% after LF and 3% after OF (p = 0.609), and heartburn in 14% after LF and 17% after OF (p = 1.000). Overall opinion of the surgical scars was good in both groups (LF: 95%, OF: 86%, p = 0.610). Patient/parental satisfaction with outcome was high, independent of surgical approach (LF: 81%, OF: 88%, p = 0.500). CONCLUSIONS: The recurrence rate was higher and recurrence occurred earlier after LF than after OF. Patient/parental satisfaction with outcome after both LF and OF was equally high.

Psychologic Distress and Anxiety in Mothers of Children With Gastroesophageal Reflux Undergoing Antireflux Surgery.

OBJECTIVES: Parents of children with a chronic illness are at risk for impaired psychosocial functioning. Gastroesophageal reflux disease (GERD) is such a disease, and no studies have investigated effects of antireflux surgery on parental psychological distress. The aims of this study were to assess psychological distress and state and trait anxiety in mothers of children with GERD, and to explore possible changes after antireflux surgery. METHODS: Mothers of children referred for antireflux surgery were included in this prospective study. Standardized questionnaires were used to evaluate psychological distress and state and trait anxiety before and 12 months after antireflux surgery. RESULTS: Of 87 eligible mothers of children with GERD, 62 (71%) agreed to participate. All children had objectively verified GERD by 24-hour pH-monitoring and/or upper gastrointestinal contrast study and unsatisfactory symptom relief of pharmacological treatment. Thirty-one (50%) mothers returned questionnaires postoperatively. Preoperatively, mothers of children undergoing antireflux surgery reported high levels of psychological distress and state anxiety, and 54% had scores indicating clinically significant psychological distress. None of the preoperative child characteristics were found to significantly influence maternal psychological distress or state anxiety. Twelve months postoperatively, both psychological distress and state anxiety were reduced. CONCLUSIONS: Mothers of children undergoing antireflux surgery reported reduced levels of psychological distress and state anxiety 12 months after the operation.

Trends in the use of gastrostomies at a tertiary paediatric referral centre.

OBJECTIVES: The aims of this study were to describe the population of paediatric patients undergoing gastrostomy placement at a Norwegian tertiary referral centre and to investigate trends over time in patient characteristics and operative technique. MATERIALS AND METHODS: Patients <15 years of age getting a primary gastrostomy from 1994 to 2012 were included in this retrospective observational study. Patient data were collected from medical records and the National Registry. RESULTS: Six-hundred forty-nine patients with a median age of 1.2 years [gestational week 30-14.9 years] were included. Neurological disorders (ND) was the most common underlying group of diagnosis (n = 311, 48%), followed by cardiac disease 104 (16%), congenital anomalies 85 (13%), respiratory disease 43 (7%), malignancy 29 (5%), and others 77 (12%). At follow-up, 162 (25%) patients were dead. A percutaneous endoscopic technique (PEG) was used in 401 (62%) patients, open surgery (OPEN) in 201 (31%) and laparoscopy (LAP) in 47 (7%). The number of gastrostomies per year more than doubled during the period (p < 0.001). More patients with cardiac disease and congenital anomalies were given a gastrostomy during the last years (all p < 0.05), whereas the number of patients with ND remained stable. Furthermore, there has been a decrease in median age and an increase in the number of PEG and LAP (p < 0.05). CONCLUSION: The number of gastrostomy insertions has increased from 1994 to 2012. NDs is the most common underlying diagnosis in patients receiving a gastrostomy, PEG is the most common technique and patient characteristics have changed during the study period.

Short and long-term outcomes after pediatric redo fundoplication.

BACKGROUND: Redo fundoplication (RF) is the most common surgical treatment for recurrent gastroesophageal reflux disease (GERD) in children, but outcomes after RF are rarely reported. The aim of this study was to assess short- and long-term outcomes after RF in childhood. METHODS: The study is a follow-up study of patients undergoing RF from 2002 to 2020 at a teriary care center. Patients/parents were sent questionnaires recording symptoms of recurrent GERD, troublesome side-effects and satisfaction. Retrospective chart review was also performed. RESULTS: 24/28 (86%) patients were included median 9 (1.6 months-17.7 years) years after RF. 16 (67%) had neurologic impairment. Indications for RF was recurrence of GERD (n = 18), discomfort or dysphagia from a herniated wrap (n = 5) and dysphagia from a slipped fundoplication (n = 1). Median operating time was 128 (95-250) min. Six (25%) patients experienced early major complications, of which two were gastrostomy related. Five (21%) patients experienced recurrence after RF. Three of these were symptom free at follow-up with medical treatment or re-RF. The most common symptom at follow-up was stomach pain (37%) and excessive flatulence (38%). 18/22 (95%) patients/parents would choose RF again, and 21/22 would recommend RF to someone in a similar situation. CONCLUSIONS: RF is successful in treating recurrent GERD after primary fundoplication, and patient/parental satisfaction is high.

Reduced complication rate after implementation of a detailed treatment protocol for percutaneous endoscopic gastrostomy with T-fastener fixation in pediatric patients: A prospective study.

BACKGROUND/AIMS: Percutaneous endoscopic gastrostomy with push technique (PEG-T) is increasingly used in pediatric patients. In a retrospective study of PEG-T (cohort 1) we reported frequent complications related to T-fasteners and tube dislodgment. The aim of this study was to assess complications after implementation of a strict treatment protocol, and to compare these with the previous retrospective study. MATERIALS AND METHODS: The study is a prospective study of PEG-T placement performed between 2017 and 2020 (cohort 2) in pediatric patients (0-18 years). Complications were recorded during hospital stay, fourteen days and three months postoperatively, graded according to the Clavien-Dindo classification and categorized as early (<30 days) or late (>30 days). RESULTS: In total 82 patients were included, of which 52 (60%) had neurologic impairments. Median age and weight were 2.0 years [6 months-18.1 years] and 13.4 kg [3.5-51.5 kg], respectively. There was a significant reduction in median operating time from 28 min [10-65 min] in cohort 1 to 15 min [6-35 min] in cohort 2 (p<0.001), number of patients with early tube dislodgement (cohort 1: 9 (10%) vs cohort 2: 1 (1%), p = 0.012), and number of patients with late migrated T-fasteners (cohort 1: 11 (13%) vs cohort 2: 1 (1%), p = 0.004). CONCLUSION: We experienced less migrated T-fasteners and tube dislodgment after implementation of strict treatment protocol. LEVEL OF EVIDENCE: Treatment study level III.

Laparoscopic Gastrostomy Placement in Children Has Few Major, but Many Minor Early Complications.

INTRODUCTION: Laparoscopic gastrostomy (LAPG) is an increasingly popular alternative to more traditional gastrostomy techniques. This study evaluates early postoperative complications following LAPG and investigates risk factors for gastrostomy complications. MATERIALS AND METHODS: Retrospective study of patients <16 years undergoing LAPG from 2005 to 2018. Early postoperative complications (<30 days) were grouped as gastrostomy-related or general and graded according to the Clavien-Dindo classification for surgical complications. RESULTS: A total of 104 patients, of which 54 (52%) had neurological impairment (NI), were included. Median age and weight were 1.2 years (1 day-15.2 years) and 8.9 kg (3.4-36), respectively. Operating time was median 37 minutes (19-86) and shorter in the second half of the patients (46 vs. 35 minutes, p = 0.04). A total of 40 (38%) patients experienced 53 gastrostomy-related complications. Of these, seven complications needed surgical treatment; severe leakage (2), too short gastrostomy button (1), feeding difficulties (1), gastric outlet obstruction (1), omentum trapped in umbilical port sutures (1), and suspected fascial defect (1). Stoma infection and granulation tissue were reported in 13 and 12%, respectively. Tube dislodgement occurred in six patients and was managed with bedside reinsertion in all. Gastrostomy-related complications were less frequent in NI patients (46 vs 22%, p = 0.01). CONCLUSION: LAPG is a safe procedure with few major complications, but a high rate of minor complications. Operating time declined during the study period, and NI patients had fewer gastrostomy-related complications.

Initial experience with percutaneous endoscopic gastrostomy with T-fastener fixation in pediatric patients.

BACKGROUND AND STUDY AIMS: Insertion of a percutaneous endoscopic gastrostomy (PEG) with push-through technique and T-fastener fixation (PEG-T) has recently been introduced in pediatric patients. The T-fasteners allow a primary insertion of a balloon gastrostomy. Due to limited data on the results of this technique in children, we have investigated peri- and postoperative outcomes after implementation of PEG-T in our department. PATIENTS AND METHODS: This retrospective chart review included all patients below 18 years who underwent PEG-T placement from 2010 to 2014. Main outcomes were 30-day postoperative complications and late gastrostomy-related complications. RESULTS: In total, 87 patients were included, and median follow-up time was 2.4 years (1 month - 4.9 years). Median age and weight at PEG-T insertion were 1.9 years (9.4 months - 16.4 years) and 10.4 kg (5.4 - 33.0 kg), respectively. Median operation time was 28 minutes (10 - 65 minutes), and 6 surgeons and 3 endoscopists performed the procedures. During the first 30 days, 54 complications occurred in 41 patients (47 %). Most common were peristomal infections treated with either local antibiotics in 11 patients (13 %) or systemic antibiotics in 11 other patients (13 %). 9 patients (10 %) experienced tube dislodgment. Late gastrostomy-related complications occurred in 33 patients (38 %). The T-fasteners caused early and late complications in 9 (10 %) and 11 patients (13 %), respectively. Of these, 4 patients (5 %) had subcutaneously migrated T-fasteners which were removed under general anesthesia. CONCLUSION: We found a high rate of complications after PEG-T. In particular, problems with the T-fasteners and tube dislodgment occurred frequently after PEG-T insertion.

Nissen fundoplication in children with and without neurological impairment: A prospective cohort study.

BACKGROUND: It is assumed that children with neurological impairment (NI) have inferior results after fundoplication compared to those without NI (non-NI). The aim of this study was to assess outcome after fundoplication in children with and without NI. METHODS: 87/105 patients (46 NI, 41 non-NI) undergoing fundoplication between 2003 and 2009 were included in this prospective two-center cohort study. Complications occurring within the first 30days were scored from 0 to 100 by the comprehensive complication index (CCI). Follow-up included clinical examination, upper gastrointestinal contrast study and 24-h pH monitoring 6months postoperatively, then phone-interviews 1, 2 and 4years later. RESULTS: There were no statistical differences in age (NI 3.1 years [0.2-15.2] vs non-NI 5.0 years [0.4-15], p=.14) or in total CCI score (NI 20.9 [0-44.9] vs non-NI 8.7 [0-40.6], p=.57). Hospital stay was longer for NI children (9days [4-57] vs non-NI: 4days [2-16], p<0.001). More than 90% of parents in both groups reported that the fundoplication had improved the child's overall condition. Recurrence of gastroesophageal reflux disease (GERD) was diagnosed in 12 NI and 7 non-NI patients (p=.31). CONCLUSIONS: Early complications, GERD recurrence, and long-term parental satisfaction after fundoplication did not differ between NI and non-NI patients.