Common use of Risk-Benefit-Assessment Clause in Contracts

Risk-Benefit-Assessment. Many pediatric surgical centers worldwide routinely perform MFR after enterostomy creation. However, due to a lack of prospective studies the level of evidence showing a benefit of this treatment strategy is low. Although the systematic review by Xxxxxxxxxx et al. [4] showed no complications using this technique, MFR into the distal bowel loop may potentially cause complications such as bowel perforation. The risk for possible complications can be minimized by careful and standardized manipulation of the enterostomies. The local condition of the ostomy will be investigated twice daily. If our hypothesis is confirmed, the postoperative hospital care of infants undergoing ostomy closure will be shortened. The benefits of MFR may include a shorter duration and therefore less side effects of parenteral nutrition. Moreover, an economic benefit through lower costs for TPN and a shorter hospital stay may be reached. The results of the current study may influence the standard of neonatal intensive care. Therefore the potential benefits of MFR outweigh the possible risks of this study. Results of data analyses including all data how to perform MFR will be published. If the results of this study will show significant differences between the intervention group and controls, MFR will become the new standard of care for neonates with enterostomies. In Germany, the current national guideline for neonatal and surgical treatment of necrotizing enterocolitis (NEC) is currently in revision [Leitlinie 024-009: Nekrotisierende Enterokolitis (NEK)]. One of the principal investigators of the study (Prof. Xx. Xxxxxx Xxxxxx) is coauthor of this guideline. If the current study proves the hypothesis that MFR is beneficial for these infants it may not only change the national guideline for the best treatment after enterostomy creation in Germany but in other countries too.

Risk-Benefit-Assessment. Many pediatric surgical centers worldwide routinely perform MFR after enterostomy creation. However, due to a lack of prospective studies the level of evidence showing a benefit of this treatment strategy is low. Although the systematic review by Xxxxxxxxxx et al. [4] showed no complications using this technique, MFR into the distal bowel loop may potentially cause complications such as bowel perforation. The risk for possible complications can be minimized by careful and standardized manipulation of the enterostomies. The local condition of the ostomy will be investigated twice daily. If our hypothesis is confirmed, the postoperative hospital care of infants undergoing ostomy closure will be shortened. The benefits of MFR may include a shorter duration and therefore less side effects of parenteral nutrition. Moreover, an economic benefit through lower costs for TPN and a shorter hospital stay may be reached. The results of the current study may influence the standard of neonatal intensive care. Therefore the potential benefits of MFR outweigh the possible risks of this study. Results of data analyses including all data how to perform MFR will be published. If the results of this study will show significant differences between the intervention group and controls, controls MFR will become the new standard of care for neonates with enterostomies. In Germany, the current national guideline for neonatal and surgical treatment of necrotizing enterocolitis (NEC) is currently in revision [Leitlinie 024-009: Nekrotisierende Enterokolitis (NEK)]. One of the principal investigators of the study (Prof. Xx. Xxxxxx Xxxxxx) is coauthor of this guideline. If the current study proves the hypothesis that MFR is beneficial for these infants it may not only change the national guideline for the best treatment after enterostomy creation in Germany but in other countries too.

Risk-Benefit-Assessment. Many pediatric surgical centers worldwide routinely perform MFR after enterostomy creation. However, due to a lack of prospective studies the level of evidence showing a benefit of this treatment strategy is low. Although the systematic review by Xxxxxxxxxx et al. [4] showed no complications using this technique, MFR into the distal bowel loop may potentially cause complications such as bowel perforation. The risk for possible complications can be minimized by careful and standardized manipulation of the enterostomies. The local condition of the ostomy will be investigated twice daily. If our hypothesis is confirmed, the postoperative hospital care of infants undergoing ostomy closure will be shortened. The benefits of MFR may include a shorter duration and therefore less side effects of parenteral nutrition, especially PN-associated liver disease (PNALD). Moreover, an economic benefit through lower costs for TPN and a shorter hospital stay may be reached. The results of the current study may influence the standard of neonatal intensive care. Therefore the potential benefits of MFR outweigh the possible risks of this study. Results of data analyses including all data how to perform MFR will be published. If the results of this study will show significant differences between the intervention group and controls, MFR will become the new standard of care for neonates with enterostomies. In Germany, the current national guideline for neonatal and surgical treatment of necrotizing enterocolitis (NEC) is currently in revision [Leitlinie 024-009: Nekrotisierende Enterokolitis (NEK)]. One of the principal investigators of the study (Prof. Xx. Xxxxxx Xxxxxx) is coauthor of this guideline. If the current study proves the hypothesis that MFR is beneficial for these infants it may not only change the national guideline for the best treatment after enterostomy creation in Germany but in other countries too.

Risk-Benefit-Assessment. ‌ Many pediatric surgical centers worldwide routinely perform MFR after enterostomy creation. However, due to a lack of prospective studies the level of evidence showing a benefit of this treatment strategy is low. Although the systematic review by Xxxxxxxxxx et al. [4] showed no complications using this technique, MFR into the distal bowel loop may potentially cause complications such as bowel perforation. The risk for possible complications can be minimized by careful and standardized manipulation of the enterostomies. The local condition of the ostomy will be investigated twice daily. If our hypothesis is confirmed, the postoperative hospital care of infants undergoing ostomy closure will be shortened. The benefits of MFR may include a shorter duration and therefore less side effects of parenteral nutrition. Moreover, an economic benefit through lower costs for TPN and a shorter hospital stay may be reached. The results of the current study may influence the standard of neonatal intensive care. Therefore the potential benefits of MFR outweigh the possible risks of this study. Results of data analyses including all data how to perform MFR will be published. If the results of this study will show significant differences between the intervention group and controls, controls MFR will become the new standard of care for neonates with enterostomies. In Germany, the current national guideline for neonatal and surgical treatment of necrotizing enterocolitis (NEC) is currently in revision [Leitlinie 024-009: Nekrotisierende Enterokolitis (NEK)]. One of the principal investigators of the study (Prof. Xx. Xxxxxx Xxxxxx) is coauthor of this guideline. If the current study proves the hypothesis that MFR is beneficial for these infants it may not only change the national guideline for the best treatment after enterostomy creation in Germany but in other countries too.