Biliary Tract Neoplasms, Hepatic Neoplasms, Pancreatic Neoplasms
Conditions
Keywords
Rehabilitation, Quality of life, Surgery, Hepatic neoplasms, Biliary tract neoplasms, Pancreatic neoplasms
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.
Interventions
BEHAVIORALPerioperative rehabilitation program
Perioperative rehabilitation program * preoperative rehabilitation : 2 weeks prior to operation * postoperative rehabilitation : 3 months after operation
BEHAVIORALConventional
conventional perioperative management without rehabilitation program
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The result of allocation in control and intervention group would be blinded to primary and secondary outcomes assessor.
Intervention model description
2 arm, parallel, randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| The incidence of operation-specific complication | till postoperative 3 months | Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed