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

November 16, 2022 updated by: Dae Wook Hwang, Asan Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center, University of Ulsan College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
No intervention; conventional perioperative management without perioperative rehabilitation program
Behavioral: Conventional
conventional perioperative management without rehabilitation program
Other Names:
  • No intervention
Experimental: Intervention - PReHeBP
conventional perioperative management with preoperative and postoperative rehabilitation program
Behavioral: Perioperative rehabilitation program

Perioperative rehabilitation program

  • preoperative rehabilitation : 2 weeks prior to operation
  • postoperative rehabilitation : 3 months after operation
Other Names:
  • PReHeBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence and severity of general complication
Time Frame: till postoperative 3 months
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
Time Frame: till postoperative 3 months
Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification
till postoperative 3 months
The incidende of Mortality
Time Frame: till postoperative 3 months
Rate of in-hospital mortality and 90 days mortality
till postoperative 3 months
Rate of re-admission
Time Frame: till postoperative 3 months
the rate of re-admission, till postoperative 3 months
till postoperative 3 months
The changes in Quality of life
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
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)
Time Frame: Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
Grasping power measurement using dynamometer
Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: DAE WOOK HWANG, M.D., Asan Medical Center, University of Ulsan College of Medicine, SEOUL, KOREA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Actual)

May 24, 2021

Study Completion (Actual)

May 24, 2021

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PReHeBP
  • 2015-665 (Other Grant/Funding Number: Asan Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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