Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy
NCT ID: NCT02784353
Last Updated: 2022-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2016-10-04
2021-05-24
Brief Summary
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Detailed Description
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There are several reports that perioperative rehabilitation affect positively for the outcome of surgery and QOL in surgical patients. However, in the HBP field, there are rarely studied for this concept.
This study aim to investigate that the application of rehabilitation program for the surgery of HBP malignancies affect on short-term outcome and lead the improvement of QOL.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Conventional
No intervention; conventional perioperative management without perioperative rehabilitation program
Conventional
conventional perioperative management without rehabilitation program
Intervention - PReHeBP
conventional perioperative management with preoperative and postoperative rehabilitation program
Perioperative rehabilitation program
Perioperative rehabilitation program
* preoperative rehabilitation : 2 weeks prior to operation
* postoperative rehabilitation : 3 months after operation
Interventions
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Perioperative rehabilitation program
Perioperative rehabilitation program
* preoperative rehabilitation : 2 weeks prior to operation
* postoperative rehabilitation : 3 months after operation
Conventional
conventional perioperative management without rehabilitation program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG 0-2
* resectable HBP malignancies or premalignant lesions which should be required GI resection and anastomosis
* open surgery
* no distant metastasis
* no functional disturbance in bone marrow; WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
* no functional disturbance in liver; AST less than 5 times upper limit of normal
* no function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal
* informed consent
Exclusion Criteria
* active or uncontrolled infection
* alcohol or other drug addiction
* already enrolled patient in other study which affect this study
* pregnant or the possibility of pregnancy (+)
* uncontrolled cardiopulmonary disease
* moderate to severe comorbidity which affect on the quality of life and nutritional status (liver cirrhosis, end stage renal disease, heart failure, etc.)
* previous history of major gastrointestinal surgery (gastrectomy, colectomy, etc.)
* previous history of neurological or musculoskeletal diseases which is impossible to allow investigator's order
18 Years
80 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Dae Wook Hwang
Assistant professor
Principal Investigators
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DAE WOOK HWANG, M.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA
Locations
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Asan Medical Center, University of Ulsan College of Medicine
Seoul, , South Korea
Countries
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References
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Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.
Ford-Smith CD, Wyman JF, Elswick RK Jr, Fernandez T. Reliability of stationary dynamometer muscle strength testing in community-dwelling older adults. Arch Phys Med Rehabil. 2001 Aug;82(8):1128-32. doi: 10.1053/apmr.2001.24291.
Johansson K, Tibe K, Weibull A, Newton RC. Low intensity resistance exercise for breast cancer patients with arm lymphedema with or without compression sleeve. Lymphology. 2005 Dec;38(4):167-80.
Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Nagino M. Preoperative sarcopenia negatively impacts postoperative outcomes following major hepatectomy with extrahepatic bile duct resection. World J Surg. 2015 Jun;39(6):1494-500. doi: 10.1007/s00268-015-2988-6.
Schwartz AL. Fatigue mediates the effects of exercise on quality of life. Qual Life Res. 1999 Sep;8(6):529-38. doi: 10.1023/a:1008978611274.
Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
Yeo TP, Burrell SA, Sauter PK, Kennedy EP, Lavu H, Leiby BE, Yeo CJ. A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll Surg. 2012 Apr;214(4):463-75; discussion 475-7. doi: 10.1016/j.jamcollsurg.2011.12.017. Epub 2012 Feb 7.
Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, You CH, West K. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004 May;13(4):863-8. doi: 10.1023/B:QURE.0000021692.81214.70.
Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
Bobbio A, Chetta A, Ampollini L, Primomo GL, Internullo E, Carbognani P, Rusca M, Olivieri D. Preoperative pulmonary rehabilitation in patients undergoing lung resection for non-small cell lung cancer. Eur J Cardiothorac Surg. 2008 Jan;33(1):95-8. doi: 10.1016/j.ejcts.2007.10.003. Epub 2007 Nov 19.
Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990 Jan-Feb;9(1-2):65-71; discussion 71-2. doi: 10.1002/sim.4780090113.
Other Identifiers
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2015-665
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PReHeBP
Identifier Type: -
Identifier Source: org_study_id
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