Clinical Outcomes Of Preoperative And Postoperative Rehabilitation In The Patients With HBP Malignancy

Study Overview

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

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.

Hepatic Neoplasms
Biliary Tract Neoplasms
Pancreatic Neoplasms

BEHAVIORAL: Perioperative rehabilitation program
BEHAVIORAL: Conventional

PReHeBP
2015-665 (OTHER_GRANT Identifier) (OTHER_GRANT: Asan Medical Center)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-05-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-11-16
First Submitted that Met QC Criteria 2016-05-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-11-17
First Posted (ACTUAL) 2016-05-27	Results First Posted N/A	Last Verified 2022-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Conventional No intervention; conventional perioperative management without perioperative rehabilitation program	BEHAVIORAL: Conventional conventional perioperative management without rehabilitation program
EXPERIMENTAL: Intervention - PReHeBP conventional perioperative management with preoperative and postoperative rehabilitation program	BEHAVIORAL: Perioperative rehabilitation program Perioperative rehabilitation program * preoperative rehabilitation : 2 weeks prior to operation * postoperative rehabilitation : 3 months after operation

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Conventional

No intervention; conventional perioperative management without perioperative rehabilitation program

BEHAVIORAL: Conventional

conventional perioperative management without rehabilitation program

EXPERIMENTAL: Intervention - PReHeBP

conventional perioperative management with preoperative and postoperative rehabilitation program

BEHAVIORAL: Perioperative rehabilitation program

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

Primary Outcome Measures	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

Secondary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

>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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: DAE WOOK HWANG, M.D., Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record