The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents
2021年9月17日 更新者：Patrick Stafler、Rabin Medical Center
In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI).
研究概览
详细说明
Morbid obesity leads to restrictive as well as obstructive ventilatory defects via mechanisms that include mechanical, as well as inflammatory factors. We hypothesise that multiple breath nitrogen washout will be more sensitive to changes in small airway function than conventional lung function testing.
We will invite adolescents with morbid obesity, scheduled to undergo bariatric surgery at SCMCI during 2016-2018, for pulmonary function testing, including spirometry, plethysmography, nitrogen multiple breath washout, lung transfer factor and 6 minute walk. These tests will be conducted prior to the operation as well as during follow-up appointments at 3, 6 and 12 months. We will also evaluate oxidative stress using highly sensitive C-reactive protein as surrogate marker.
研究类型
观察性的
注册 (预期的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Patrick Stafler, MD
- 电话号码：972-54-7243623
- 邮箱：pstafler@hotmail.com
学习地点
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Petach Tikva、以色列、49202
- 招聘中
- Schneider Children's Medical Center of Israel
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接触：
- Patrick Stafler, MD
- 电话号码：972547243623
- 邮箱：pstafler@hotmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
11年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Adolescents with morbid obesity who will undergo bariatric surgery
描述
Inclusion Criteria:
- Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018
Exclusion Criteria:
- Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change from Baseline Lung Clearance Index
大体时间：3 months post op
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3 months post op
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from Baseline High sensitivity C reactive protein
大体时间：3 months post op
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3 months post op
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Li AM, Chan D, Wong E, Yin J, Nelson EA, Fok TF. The effects of obesity on pulmonary function. Arch Dis Child. 2003 Apr;88(4):361-3. doi: 10.1136/adc.88.4.361.
- Lazarus R, Colditz G, Berkey CS, Speizer FE. Effects of body fat on ventilatory function in children and adolescents: cross-sectional findings from a random population sample of school children. Pediatr Pulmonol. 1997 Sep;24(3):187-94. doi: 10.1002/(sici)1099-0496(199709)24:33.0.co;2-k.
- Kelleher DC, Merrill CT, Cottrell LT, Nadler EP, Burd RS. Recent national trends in the use of adolescent inpatient bariatric surgery: 2000 through 2009. JAMA Pediatr. 2013 Feb;167(2):126-32. doi: 10.1001/2013.jamapediatrics.286.
- Kalra M, Inge T, Garcia V, Daniels S, Lawson L, Curti R, Cohen A, Amin R. Obstructive sleep apnea in extremely overweight adolescents undergoing bariatric surgery. Obes Res. 2005 Jul;13(7):1175-9. doi: 10.1038/oby.2005.139.
- Abu-Abeid S, Gavert N, Klausner JM, Szold A. Bariatric surgery in adolescence. J Pediatr Surg. 2003 Sep;38(9):1379-82. doi: 10.1016/s0022-3468(03)00400-7.
- Weiner P, Waizman J, Weiner M, Rabner M, Magadle R, Zamir D. Influence of excessive weight loss after gastroplasty for morbid obesity on respiratory muscle performance. Thorax. 1998 Jan;53(1):39-42. doi: 10.1136/thx.53.1.39.
- Davila-Cervantes A, Dominguez-Cherit G, Borunda D, Gamino R, Vargas-Vorackova F, Gonzalez-Barranco J, Herrera MF. Impact of surgically-induced weight loss on respiratory function: a prospective analysis. Obes Surg. 2004 Nov-Dec;14(10):1389-92. doi: 10.1381/0960892042583996.
- Santana AN, Souza R, Martins AP, Macedo F, Rascovski A, Salge JM. The effect of massive weight loss on pulmonary function of morbid obese patients. Respir Med. 2006 Jun;100(6):1100-4. doi: 10.1016/j.rmed.2005.09.021. Epub 2005 Oct 21.
- Nguyen NT, Hinojosa MW, Smith BR, Gray J, Varela E. Improvement of restrictive and obstructive pulmonary mechanics following laparoscopic bariatric surgery. Surg Endosc. 2009 Apr;23(4):808-12. doi: 10.1007/s00464-008-0084-9. Epub 2008 Sep 20.
- Sahebjami H, Gartside PS. Pulmonary function in obese subjects with a normal FEV1/FVC ratio. Chest. 1996 Dec;110(6):1425-9. doi: 10.1378/chest.110.6.1425.
- Rubinstein I, Zamel N, DuBarry L, Hoffstein V. Airflow limitation in morbidly obese, nonsmoking men. Ann Intern Med. 1990 Jun 1;112(11):828-32. doi: 10.7326/0003-4819-112-11-828. Erratum In: Ann Intern Med 1990 Aug 15;113(4):334.
- Hakala K, Mustajoki P, Aittomaki J, Sovijarvi AR. Effect of weight loss and body position on pulmonary function and gas exchange abnormalities in morbid obesity. Int J Obes Relat Metab Disord. 1995 May;19(5):343-6.
- Thomas PS, Cowen ER, Hulands G, Milledge JS. Respiratory function in the morbidly obese before and after weight loss. Thorax. 1989 May;44(5):382-6. doi: 10.1136/thx.44.5.382.
- Vaughan RW, Cork RC, Hollander D. The effect of massive weight loss on arterial oxygenation and pulmonary function tests. Anesthesiology. 1981 Apr;54(4):325-8. doi: 10.1097/00000542-198104000-00013.
- Sugerman HJ, Baron PL, Fairman RP, Evans CR, Vetrovec GW. Hemodynamic dysfunction in obesity hypoventilation syndrome and the effects of treatment with surgically induced weight loss. Ann Surg. 1988 May;207(5):604-13. doi: 10.1097/00000658-198805000-00015.
- Boone KA, Cullen JJ, Mason EE, Scott DH, Doherty C, Maher JW. Impact of Vertical Banded Gastroplasty on Respiratory Insufficiency of Severe Obesity. Obes Surg. 1996 Dec;6(6):454-458. doi: 10.1381/096089296765556322.
- Scheuller M, Weider D. Bariatric surgery for treatment of sleep apnea syndrome in 15 morbidly obese patients: long-term results. Otolaryngol Head Neck Surg. 2001 Oct;125(4):299-302. doi: 10.1067/mhn.2001.119139.
- Dixon JB, Schachter LM, O'Brien PE. Polysomnography before and after weight loss in obese patients with severe sleep apnea. Int J Obes (Lond). 2005 Sep;29(9):1048-54. doi: 10.1038/sj.ijo.0802960.
- Aaron SD, Fergusson D, Dent R, Chen Y, Vandemheen KL, Dales RE. Effect of weight reduction on respiratory function and airway reactivity in obese women. Chest. 2004 Jun;125(6):2046-52. doi: 10.1378/chest.125.6.2046.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年5月1日
初级完成 (预期的)
2023年1月1日
研究完成 (预期的)
2023年1月1日
研究注册日期
首次提交
2015年12月30日
首先提交符合 QC 标准的
2015年12月30日
首次发布 (估计)
2015年12月31日
研究记录更新
最后更新发布 (实际的)
2021年9月23日
上次提交的符合 QC 标准的更新
2021年9月17日
最后验证
2021年9月1日
更多信息
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