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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02784353

Collaborator

(none)

158

Enrollment

Location

Arms

42.8

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Neoplasms Biliary Tract Neoplasms Pancreatic Neoplasms	Behavioral: Perioperative rehabilitation program Behavioral: Conventional	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 arm, parallel, randomized controlled study2 arm, parallel, randomized controlled study

Masking:

Single (Outcomes Assessor)

Masking Description:

The result of allocation in control and intervention group would be blinded to primary and secondary outcomes assessor.

Primary Purpose:

Supportive Care

Official Title:

Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP(Hepatobiliary and Pancreatic) Malignancy

Actual Study Start Date :

Oct 4, 2016

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional No intervention; conventional perioperative management without perioperative rehabilitation program	Behavioral: Conventional conventional perioperative management without rehabilitation program Other Names: No intervention
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 Other Names: PReHeBP

Arm

Intervention/Treatment

Active Comparator: Conventional

No intervention; conventional perioperative management without perioperative rehabilitation program

Behavioral: Conventional

conventional perioperative management without rehabilitation program

Other Names:

No intervention

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

Other Names:

PReHeBP

Outcome Measures

Primary Outcome Measures

The incidence and severity of general complication [till postoperative 3 months]
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 [till postoperative 3 months]
Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification
The incidende of Mortality [till postoperative 3 months]
Rate of in-hospital mortality and 90 days mortality
Rate of re-admission [till postoperative 3 months]
the rate of re-admission, till postoperative 3 months
The changes in Quality of life [Comparison between at the time of discharge and postoperative 3months]
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) [Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery]
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) [Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery]
Measure the 6 minutes walk test (m/minute)
Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation) [Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery]
Grasping power measurement using dynamometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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