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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

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02784353

First Posted

May 6, 2016

Last Updated

November 16, 2022

Sponsor

Asan Medical Center

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

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

Citations:

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5523831

Citation

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Citation

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Citation

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Citation

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

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