Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy

NCT02784353 | Completed DMC

• 2 other identifiers: PReHeBP2015-665
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.

Conditions

Hepatic Neoplasms; Biliary Tract Neoplasms; Pancreatic Neoplasms

Keywords

Rehabilitation; Quality of life; Surgery; Hepatic neoplasms; Biliary tract neoplasms; Pancreatic neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• The incidence of operation-specific complication

  till postoperative 3 months

• The incidende of Mortality

  till postoperative 3 months

• Rate of re-admission

  till postoperative 3 months

• The changes in Quality of life

  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)

  Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery

Study Arms (2)

Conventional

ACTIVE COMPARATOR

No intervention; conventional perioperative management without perioperative rehabilitation program

Behavioral: Conventional

Intervention - PReHeBP

EXPERIMENTAL

conventional perioperative management with preoperative and postoperative rehabilitation program

Behavioral: Perioperative rehabilitation program

Interventions

Perioperative rehabilitation program BEHAVIORAL

Perioperative rehabilitation program * preoperative rehabilitation : 2 weeks prior to operation * postoperative rehabilitation : 3 months after operation

Also known as: PReHeBP

Intervention - PReHeBP

Conventional BEHAVIORAL

conventional perioperative management without rehabilitation program

Also known as: No intervention

Conventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old or \<80 years old
• 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

You may not qualify if:

• distant metastasis (+) or recurred HBP tumor
• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

Related Publications (11)

• Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.

  PMID: 5523831 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.

  PMID: 11494194 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.

  PMID: 16515225 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.

  PMID: 25651963 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.

  PMID: 10548868 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.

  PMID: 21205966 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.

  PMID: 22321518 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.

  PMID: 15129896 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.

  PMID: 10960937 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.

  PMID: 18006327 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.

  PMID: 2345839 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Biliary Tract Neoplasms; Pancreatic Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• DAE WOOK HWANG, M.D.

  Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The result of allocation in control and intervention group would be blinded to primary and secondary outcomes assessor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 2 arm, parallel, randomized controlled study

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 27, 2016
• Study Start: October 4, 2016
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)