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

Not Applicable

Completed

• Conditions: Biliary Tract Neoplasms; Pancreatic Neoplasms; Hepatic Neoplasms
• Interventions: Behavioral: Perioperative rehabilitation program; Behavioral: Conventional

• Registration Number: NCT02784353
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Study Start: 2016-10-04
• Primary Completion: 2021-05-24
• Study Completion: 2021-05-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention - PReHeBP	Perioperative rehabilitation program	conventional perioperative management with preoperative and postoperative rehabilitation program
Conventional	Conventional	No intervention; conventional perioperative management without perioperative rehabilitation program

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The incidence of operation-specific complication	till postoperative 3 months	Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification
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
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 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
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

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of