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

Pancreatic Neoplasms Clinical Trial

— PReHeBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784353
• Other study ID #: PReHeBP
• Secondary ID: 2015-665
• Status: Completed
• Phase: N/A
• Start date: October 4, 2016
• Est. completion date: May 24, 2021

Study information

• Verified date: November 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 24, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Hepatic Neoplasms
• Liver Neoplasms
• Neoplasms
• Pancreatic Neoplasms

Intervention

Behavioral:
• Perioperative rehabilitation program
Perioperative rehabilitation program preoperative rehabilitation : 2 weeks prior to operation postoperative rehabilitation : 3 months after operation
• Conventional
conventional perioperative management without rehabilitation program

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

Bobbio A, Chetta A, Ampollini L, Primomo GL, Internullo E, Carbognani P, Rusca M, Olivieri D. Preoperative pulmonary rehabilitation in patients undergoing lung resection for non-small cell lung cancer. Eur J Cardiothorac Surg. 2008 Jan;33(1):95-8. Epub 20 — View Citation

Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. — View Citation

Ford-Smith CD, Wyman JF, Elswick RK Jr, Fernandez T. Reliability of stationary dynamometer muscle strength testing in community-dwelling older adults. Arch Phys Med Rehabil. 2001 Aug;82(8):1128-32. — View Citation

Johansson K, Tibe K, Weibull A, Newton RC. Low intensity resistance exercise for breast cancer patients with arm lymphedema with or without compression sleeve. Lymphology. 2005 Dec;38(4):167-80. — View Citation

Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Nagino M. Preoperative sarcopenia negatively impacts postoperative outcomes following major hepatectomy with extrahepatic bile duct resection. World J Surg. 2015 Jun;39(6):1494-500. doi: 10.100 — View Citation

Schwartz AL. Fatigue mediates the effects of exercise on quality of life. Qual Life Res. 1999 Sep;8(6):529-38. — View Citation

Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903. — View Citation

Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JA — View Citation

Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990 Jan-Feb;9(1-2):65-71; discussion 71-2. — View Citation

Yeo TP, Burrell SA, Sauter PK, Kennedy EP, Lavu H, Leiby BE, Yeo CJ. A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll Surg. 2012 Apr;214( — View Citation

Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, You CH, West K. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004 May;13(4):863-8. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of general complication	Incidence rate and severity of general complications except operation-specific complication, according to Clavien-Dindo classification	till postoperative 3 months
Secondary	The incidence of operation-specific complication	Incidence rate and severity of operation-specific complication, according to Clavien-Dindo classification	till postoperative 3 months
Secondary	The incidende of Mortality	Rate of in-hospital mortality and 90 days mortality	till postoperative 3 months
Secondary	Rate of re-admission	the rate of re-admission, till postoperative 3 months	till postoperative 3 months
Secondary	The changes in Quality of life	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
Secondary	Compliance of Aerobic exercise, strength exercise and respiratory excursion (Changes in the parameters of rehabilitation)	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
Secondary	Measurement on 6 minutes walk test (m/minute) (Changes in the parameters of rehabilitation)	Measure the 6 minutes walk test (m/minute)	Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery
Secondary	Grasping power(dynamometer, kg)(Changes in the parameters of rehabilitation)	Grasping power measurement using dynamometer	Initial(2 weeks before surgery), preoperative (within 2days prior to surgery) and 3 months after surgery