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

Study Overview
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Brief Summary
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Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy.

Detailed Description
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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.

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

Conditions
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Hepatic Neoplasms, Biliary Tract Neoplasms, Pancreatic Neoplasms

Intervention / Treatment
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* Behavioral: Perioperative rehabilitation program
* Behavioral: Conventional


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arm, parallel, randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>No intervention; conventional perioperative management without perioperative rehabilitation program | Behavioral: Conventional<br>* conventional perioperative management without rehabilitation program<br>* Other names: No intervention;|
| Experimental: Intervention - PReHeBP<br>conventional perioperative management with preoperative and postoperative rehabilitation program | Behavioral: Perioperative rehabilitation program<br>* Perioperative rehabilitation program preoperative rehabilitation : 2 weeks prior to operation postoperative rehabilitation : 3 months after operation<br>* Other names: PReHeBP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Quality of life, Surgery, Hepatic neoplasms, Biliary tract neoplasms, Pancreatic neoplasms