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NCT Number: NCT02784353

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

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

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Key information

Conditions

Hepatic Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perioperative rehabilitation program

Behavioral

Perioperative rehabilitation program

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

Other names: PReHeBP

Conventional

Behavioral

conventional perioperative management without rehabilitation program

Other names: No intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. The incidende of Mortality

    Time frame: till postoperative 3 months

    Rate of in-hospital mortality and 90 days mortality

  3. Rate of re-admission

    Time frame: till postoperative 3 months

    the rate of re-admission, till postoperative 3 months

  4. 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

  5. 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

  6. 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)

  7. 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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: PReHeBP

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 27, 2016
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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