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Fewer patients than anticipated were referred
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open fundoplication | Active Comparator | Fundoplication performed with open surgery |
|
| Lap fundoplication | Experimental | Primary fundoplication performed by laparoscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fundoplication | Procedure | Primary fundoplication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of reflux | GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI. | 12, 24 and 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complication rate | Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital. | 30 days |
| Inflammatory response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Bjornland, MD, PhD | Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35915187 | Derived | Fyhn TJ, Kvello M, Edwin B, Schistad O, Pripp AH, Emblem R, Knatten CK, Bjornland K. Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial. Surg Endosc. 2023 Jan;37(1):189-199. doi: 10.1007/s00464-022-09458-6. Epub 2022 Aug 1. | |
| 31124989 | Derived |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D018662 | Fundoplication |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Fundoplication | Procedure | Primary fundoplication |
|
|
indicies of inflammatory response
| The first 4 p.o days |
| Parental stress | Indicies of parental stress caused by GER pre- and postoperatively | 12 and 24 months |
| Kvello M, Avitsland TL, Knatten CK, Fyhn TJ, Malt U, Emblem R, Bjornland K. Psychologic Distress and Anxiety in Mothers of Children With Gastroesophageal Reflux Undergoing Antireflux Surgery. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):818-823. doi: 10.1097/MPG.0000000000002286. |
| D004066 | Digestive System Diseases |