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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-665 | Other Grant/Funding Number | Asan Medical Center |
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Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.
The most important outcome in the management of HBP malignancies is survival. Since the application of ERAS (enhanced recovery after surgery), the improvement of QOL(quality of life) has been known as one of important factor for the management of HBP malignancies as well as survival, and the improvement of QOL, itself, affect the survival.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | No intervention; conventional perioperative management without perioperative rehabilitation program |
|
| Intervention - PReHeBP | Experimental | conventional perioperative management with preoperative and postoperative rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative rehabilitation program | Behavioral | Perioperative rehabilitation program
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of general complication | Incidence rate and severity of general complications except operation-specific complication, according to Clavien-Dindo classification | till postoperative 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of operation-specific complication | Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification | till postoperative 3 months |
| The incidende of Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DAE WOOK HWANG, M.D. | Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center, University of Ulsan College of Medicine | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5523831 | Result | Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available. | |
| 11494194 | Result | 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. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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2 arm, parallel, randomized controlled study
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The result of allocation in control and intervention group would be blinded to primary and secondary outcomes assessor.
|
| Conventional | Behavioral | conventional perioperative management without rehabilitation program |
|
|
Rate of in-hospital mortality and 90 days mortality
| till postoperative 3 months |
| Rate of re-admission | the rate of re-admission, till postoperative 3 months | till postoperative 3 months |
| The changes in Quality of life | changes in quality of life (EORTC QLQ-C30), at the time of discharge and 3 months after surgery | Comparison between at the time of discharge and postoperative 3months |
| Compliance of Aerobic exercise, strength exercise and respiratory excursion (Changes in the parameters of rehabilitation) | Compliance of Aerobic exercise, strength exercise and respiratory excursion based on exercise diary | Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery |
| Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation) | Measure the 6 minutes walk test (m/minute) | Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery |
| Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation) | Grasping power measurement using dynamometer | Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery |
| 16515225 | Result | 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. |
| 25651963 | Result | 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. |
| 10548868 | Result | 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. |
| 21205966 | Result | 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. |
| 22321518 | Result | 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. |
| 15129896 | Result | 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. |
| 10960937 | Result | 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. |
| 18006327 | Result | 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. |
| 2345839 | Result | 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. |
| D008107 |
| Liver Diseases |
| D001660 | Biliary Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |