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.

Randomized Controlled Trial of Laparoscopic and Open Nissen Fundoplication in Children.

OBJECTIVE: The aim was to compare recurrence of gastroesophageal reflux disease (GERD) in children randomized to laparoscopic (LF) or open Nissen fundoplication (OF). BACKGROUND: LF is considered superior to OF by most pediatric surgeons even though this has not been shown in any randomized controlled trial in children. METHODS: Patients referred for fundoplication between 2003 and 2009 were eligible for inclusion in this 2-center, unstratified, randomized, parallel-group study conducted in Norway. The main outcome measure was recurrence of GERD, which was defined as GERD combined with a reflux index greater than 4 on pH monitoring and/or gastroesophageal reflux and/or herniated wrap on upper gastrointestinal (UGI) contrast study. Only experienced laparoscopic surgeons performed the LF. Postoperative follow-up included 24-hour pH monitoring, UGI contrast study, and a clinical examination at 6 months and phone interviews after 1, 2, and 4 years. RESULTS: Eighty-seven children were included and randomized to either LF (n = 44) or OF (n = 43). Median age was 4.7 years (0.2-15.4) in the LF group and 3.7 years (0.2-14.2) in the OF group. Twenty-three patients in both groups were neurologically impaired. Median follow-up time was 4.0 years (0.3-8.9). Significantly more patients undergoing LF (37%) experienced recurrence of GERD compared to those undergoing OF (7%); risk ratio for recurrence in the LF group was 5.2 (95% confidence interval: 1.6-16.6) (P = 0.001). CONCLUSIONS: Children operated with LF have a higher recurrence rate of GERD than those operated with OF.

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.

Short-term parent reported recovery following open and laparoscopic fundoplication.

BACKGROUND: It is assumed that children recover faster after laparoscopic (LF) than after open fundoplication (OF). As this has not been confirmed in any randomized study (RCT), we have in a subsection of a larger RCT compared parent reported recovery of children after LF and OF. METHODS: Postoperative symptoms, use of analgesics, overall well-being, and time to return to school/day-care were recorded in a subsection of children enrolled in a RCT comparing LF and OF. Ethical approval and parental consent were obtained. RESULTS: Fifty-five children (LF: n = 27, OF: n = 28) of the 88 enrolled in the RCT, were included in the short term follow up on parent reported recovery. Caregivers were interviewed median 28 days [interquartile range (IQR) 22-36] postoperatively. There was no significant difference regarding improvement in overall well-being (LF: 63%, OF: 68%, p = 0.70), new-onset dysphagia (LF: 30%, OF: 18%, p = 0.08), use of analgesics (LF: 15%, OF: 14%, p = 1.00), or time to return to school/day-care (LF: median 7 days [IQR 5-14] vs. OF: 12 days [IQR 7-15], p = 0.35). CONCLUSION: We could not demonstrate faster recovery after LF than after OF. Most children had returned to school/day-care after 2 weeks and had improved overall well-being 1 month after surgery. TYPE OF STUDY: Randomized controlled trial. LEVEL OF EVIDENCE: Level II.

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.

Thirty-day outcome in children randomized to open and laparoscopic Nissen fundoplication.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) is considered by some to be superior to open Nissen fundoplication (ONF). To test this hypothesis, we compared early results after LNF and ONF in a randomized trial. METHODS: All children accepted for antireflux surgery for gastroesophageal reflux disease were offered enrollment. Ethical approval and parental consent were obtained. Anesthesia, surgical methods, and postoperative treatment were standardized. Patient demographics, length of hospital stay (LOS), and complications occurring the first 30 postoperative days were registered. RESULTS: Eighty-eight children were randomized to LNF (n = 44) or ONF (n = 44). The groups were comparable with regard to age, weight, and comorbidity. Duration of surgery was 150 ± 34 minutes for LNF and 89 ± 25 minutes for ONF (P < .001). Median LOS was 7.0 days (range, 3-57 days) and 7.5 days (range, 2-20 days) after LNF and ONF, respectively (P = .74). Postoperative complications occurred in 48 patients, 24 in both groups. Twenty-four patients (LNF: n = 12, ONF: n = 11) were readmitted to hospital because of complications occurring after discharge. CONCLUSIONS: This study failed to show that LNF is superior to ONF when surgery duration, LOS, and complications occurring during the first postoperative month were compared. Apart from surgery duration, the results were surprisingly similar.