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

Asan Medical Center

Status

Completed

Conditions

Hepatic Neoplasms

Biliary Tract Neoplasms

Pancreatic Neoplasms

Treatments

Behavioral: Conventional

Behavioral: Perioperative rehabilitation program

Study type

Interventional

Funder types

Other

Identifiers

NCT02784353

2015-665 (Other Grant/Funding Number)

PReHeBP

Details and patient eligibility

About

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

Full 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.

Enrollment

158 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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