Clinical trial NCT02784353: Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy
Official title: Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP(Hepatobiliary and Pancreatic) Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Neoplasms
Biliary Tract Neoplasms
Pancreatic Neoplasms
Keywords: Rehabilitation
Quality of life
Surgery
Hepatic neoplasms
Biliary tract neoplasms
Pancreatic neoplasms
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm, parallel, randomized controlled study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The incidence and severity of general complication
timeFrame: till postoperative 3 months
Secondary outcomes:
measure: The incidence of operation-specific complication
timeFrame: till postoperative 3 months
measure: The incidende of Mortality
timeFrame: till postoperative 3 months
measure: Rate of re-admission
timeFrame: till postoperative 3 months
measure: The changes in Quality of life
timeFrame: Comparison between at the time of discharge and postoperative 3months
measure: Compliance of Aerobic exercise, strength exercise and respiratory excursion (Changes in the parameters of rehabilitation)
timeFrame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
measure: Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation)
timeFrame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
measure: Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation)
timeFrame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
Study officials:
affiliation: Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA
name: DAE WOOK HWANG, M.D.
role: PRINCIPAL_INVESTIGATOR
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