Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy (PReHeBP)
Primary Purpose
Hepatic Neoplasms, Biliary Tract Neoplasms, Pancreatic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Perioperative rehabilitation program
Conventional
Sponsored by
About this trial
This is an interventional supportive care trial for Hepatic Neoplasms focused on measuring Rehabilitation, Quality of life, Surgery, Hepatic neoplasms, Biliary tract neoplasms, Pancreatic neoplasms
Eligibility Criteria
Inclusion Criteria:
- >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
Exclusion Criteria:
- 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
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional
Intervention - PReHeBP
Arm Description
No intervention; conventional perioperative management without perioperative rehabilitation program
conventional perioperative management with preoperative and postoperative rehabilitation program
Outcomes
Primary Outcome Measures
The incidence and severity of general complication
Incidence rate and severity of general complications except operation-specific complication, according to Clavien-Dindo classification
Secondary Outcome Measures
The incidence of operation-specific complication
Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification
The incidende of Mortality
Rate of in-hospital mortality and 90 days mortality
Rate of re-admission
the rate of re-admission, 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
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
Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation)
Measure the 6 minutes walk test (m/minute)
Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation)
Grasping power measurement using dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784353
Brief Title
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy
Acronym
PReHeBP
Official Title
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP(Hepatobiliary and Pancreatic) Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
May 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Neoplasms, Biliary Tract Neoplasms, Pancreatic Neoplasms
Keywords
Rehabilitation, Quality of life, Surgery, Hepatic neoplasms, Biliary tract neoplasms, Pancreatic neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arm, parallel, randomized controlled study
Masking
Outcomes Assessor
Masking Description
The result of allocation in control and intervention group would be blinded to primary and secondary outcomes assessor.
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
No intervention; conventional perioperative management without perioperative rehabilitation program
Arm Title
Intervention - PReHeBP
Arm Type
Experimental
Arm Description
conventional perioperative management with preoperative and postoperative rehabilitation program
Intervention Type
Behavioral
Intervention Name(s)
Perioperative rehabilitation program
Other Intervention Name(s)
PReHeBP
Intervention Description
Perioperative rehabilitation program
preoperative rehabilitation : 2 weeks prior to operation
postoperative rehabilitation : 3 months after operation
Intervention Type
Behavioral
Intervention Name(s)
Conventional
Other Intervention Name(s)
No intervention
Intervention Description
conventional perioperative management without rehabilitation program
Primary Outcome Measure Information:
Title
The incidence and severity of general complication
Description
Incidence rate and severity of general complications except operation-specific complication, according to Clavien-Dindo classification
Time Frame
till postoperative 3 months
Secondary Outcome Measure Information:
Title
The incidence of operation-specific complication
Description
Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification
Time Frame
till postoperative 3 months
Title
The incidende of Mortality
Description
Rate of in-hospital mortality and 90 days mortality
Time Frame
till postoperative 3 months
Title
Rate of re-admission
Description
the rate of re-admission, till postoperative 3 months
Time Frame
till postoperative 3 months
Title
The changes in Quality of life
Description
changes in quality of life (EORTC QLQ-C30), at the time of discharge and 3 months after surgery
Time Frame
Comparison between at the time of discharge and postoperative 3months
Title
Compliance of Aerobic exercise, strength exercise and respiratory excursion (Changes in the parameters of rehabilitation)
Description
Compliance of Aerobic exercise, strength exercise and respiratory excursion based on exercise diary
Time Frame
Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
Title
Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation)
Description
Measure the 6 minutes walk test (m/minute)
Time Frame
Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
Title
Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation)
Description
Grasping power measurement using dynamometer
Time Frame
Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DAE WOOK HWANG, M.D.
Organizational Affiliation
Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy
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