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The Effect of Intelligent Exercise on Vascular Function, Grip Strength and Adherence in Patients With AVF After Surgery

Primary Purpose

Arteriovenous Fistula, Isometric Exercise

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Forearm isometric exercise intervention program
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Arteriovenous Fistula focused on measuring vascular function, muscle strength, adherence

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 20 years old Regular follow-up in the nephrology clinic Diagnosed with chronic kidney disease at stage 5 (or 5D) Expect to do the first autologous arteriovenous fistula surgery Exclusion Criteria: Not the first autologous arteriovenous fistula surgery Have undergone percutaneous transluminal angioplasty in the arm receiving autologous arteriovenous fistula Have undergone orthopedic disease-related surgery in the arm receiving autologous arteriovenous fistula Have been cardiovascular events within the past 3 months Have been heart function Left ventricular ejection fraction within the past 3 months <30%.

Sites / Locations

  • National Taipei University of Nursing and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

Participants performed wrist-forearm exercise training within 2 weeks after the operation, that is, from 24 hours to 2 weeks after the operation, twice a day in the morning and evening, 3 groups each time, and each single item was repeated 5 times in each group (maintain for 5 seconds). Exercise for 40 minutes a day, use the mobile phone to install the forearm isometric exercise software program within the 3rd to 8th week, use the Bluetooth device to connect the hand-held gripper to perform the forearm isometric exercise, 2 times a day, morning and evening, and train 3 groups each time, 20 times each time , hand grip strength for 3 seconds each time, increase by 1 second per week, and rest for 90 seconds between groups.

The control group began to use soft rubber balls for isometric contraction exercise from the 2nd day to the 8th week after operation. 2 times a day in the morning and evening, 3 groups of training each time, each group holds the ball for 5 minutes, and rests for 90 seconds between groups. Each grip training must be completed 20 times within 1 minute (keep 3 seconds each time in the first week) , increase by 2 seconds every week, and keep each grasping time for 10 seconds from the 5th to the 8th week.

Outcomes

Primary Outcome Measures

Vascular function in postoperative arteriovenous fistula
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at two weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at four weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at eight weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Clinical assessment of arteriovenous fistula maturity
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Change from Baseline Clinical assessment of arteriovenous fistula maturity at four weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Change from Baseline Clinical assessment of arteriovenous fistula maturity at eight weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Ultrasonic evaluation of arteriovenous fistula maturity
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at four weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at eight weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Hand Grip Strength
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at two weeks
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at four weeks
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at eight weeks
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.

Secondary Outcome Measures

Rate of participants' exercise adherence
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Change from Baseline Rate of Adherence at four weeks
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Change from Baseline Rate of Adherence at eight weeks
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.

Full Information

First Posted
November 24, 2022
Last Updated
March 9, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Taipei Veterans General Hospital, Taiwan, Taiwan Nurses Association
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1. Study Identification

Unique Protocol Identification Number
NCT05686200
Brief Title
The Effect of Intelligent Exercise on Vascular Function, Grip Strength and Adherence in Patients With AVF After Surgery
Official Title
The Effect of Intelligent Forearm Isometric Exercise on Vascular Function, Hand Grip Strength and Adherence in Patients With First Autologous Arteriovenous Fistula After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Taipei Veterans General Hospital, Taiwan, Taiwan Nurses Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Isometric exercise can effectively promote the vascular function of arteriovenous fistula and increase hand grip strength, but patients needs to perform isometric exercises patiently. The purpose of this study want investigate the effect of using individual intelligent devices for forearm isometric exercise training on the increase of arteriovenous fistula vascular function and hand grip strength, and the improvement of patients' adherence with forearm isometric exercise.
Detailed Description
An arteriovenous fistula(AVF) is the most preferred and safe vascular access for long-term hemodialysis patients. Isometric exercise can effectively promote the vascular function of AVF and increase hand grip strength, but patients needs to perform isometric exercises patiently. However, the patient's disease factors, muscle soreness caused by the exercise process, etc., may easily prevent the patient from effectively performing isometric exercise every day.This study will be the first isometric exercise training intervention program for eight weeks after AVF surgery with an intelligent device in Taiwan. Investigators expect to promote the vascular function of AVF and increase hand grip strength, as well as improve participant' adherence performance after the re-intervention protocol. To construct an intelligent forearm isometric exercise, as a reference for clinical care guidance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula, Isometric Exercise
Keywords
vascular function, muscle strength, adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants performed wrist-forearm exercise training within 2 weeks after the operation, that is, from 24 hours to 2 weeks after the operation, twice a day in the morning and evening, 3 groups each time, and each single item was repeated 5 times in each group (maintain for 5 seconds). Exercise for 40 minutes a day, use the mobile phone to install the forearm isometric exercise software program within the 3rd to 8th week, use the Bluetooth device to connect the hand-held gripper to perform the forearm isometric exercise, 2 times a day, morning and evening, and train 3 groups each time, 20 times each time , hand grip strength for 3 seconds each time, increase by 1 second per week, and rest for 90 seconds between groups.
Arm Title
Control group
Arm Type
Other
Arm Description
The control group began to use soft rubber balls for isometric contraction exercise from the 2nd day to the 8th week after operation. 2 times a day in the morning and evening, 3 groups of training each time, each group holds the ball for 5 minutes, and rests for 90 seconds between groups. Each grip training must be completed 20 times within 1 minute (keep 3 seconds each time in the first week) , increase by 2 seconds every week, and keep each grasping time for 10 seconds from the 5th to the 8th week.
Intervention Type
Behavioral
Intervention Name(s)
Forearm isometric exercise intervention program
Intervention Description
Experimental group using the intelligent gripper for forearm isometric exercise in the 3rd to 8th participants after operation, and using the smart mobile phone to install the forearm isometric exercise training game program software to provides an interactive and real- time exercise grip strength feedback mechanism, which are uses the interest of the participant to complete the forearm isometric exercise every day, and can implement the isometric exercise training for fistulization. Study nurses will track exercise adherence with telephone interviews 2, 4 and 8 participants after participant exercise intervention.
Primary Outcome Measure Information:
Title
Vascular function in postoperative arteriovenous fistula
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Time Frame
Baseline, pre-intervention (T0)
Title
Change from Baseline Vascular function in postoperative arteriovenous fistula at two weeks
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Time Frame
Baseline and Weeks 2 (T1)
Title
Change from Baseline Vascular function in postoperative arteriovenous fistula at four weeks
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Time Frame
Baseline and Weeks 4 (T2)
Title
Change from Baseline Vascular function in postoperative arteriovenous fistula at eight weeks
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Time Frame
Baseline and Weeks 8 (T3)
Title
Clinical assessment of arteriovenous fistula maturity
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Time Frame
Baseline, post-intervention(T1)
Title
Change from Baseline Clinical assessment of arteriovenous fistula maturity at four weeks
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Time Frame
Baseline and Weeks 4(T2)
Title
Change from Baseline Clinical assessment of arteriovenous fistula maturity at eight weeks
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Time Frame
Baseline and Weeks 8(T3)
Title
Ultrasonic evaluation of arteriovenous fistula maturity
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Time Frame
Baseline, two weeks after intervention(T1)
Title
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at four weeks
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Time Frame
Baseline and Weeks 4(T2)
Title
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at eight weeks
Description
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Time Frame
Baseline and Weeks 8(T3)
Title
Hand Grip Strength
Description
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Time Frame
Baseline, before exercise intervention(T0)
Title
Change from Baseline Hand Grip Strength at two weeks
Description
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Time Frame
Baseline and Weeks 2 (T1)
Title
Change from Baseline Hand Grip Strength at four weeks
Description
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Time Frame
Baseline and Weeks 4(T2)
Title
Change from Baseline Hand Grip Strength at eight weeks
Description
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Time Frame
Baseline and Weeks 8 (T3)
Secondary Outcome Measure Information:
Title
Rate of participants' exercise adherence
Description
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Time Frame
Baseline, two weeks after intervention(T1)
Title
Change from Baseline Rate of Adherence at four weeks
Description
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Time Frame
Baseline and Weeks 4(T2)
Title
Change from Baseline Rate of Adherence at eight weeks
Description
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Time Frame
Baseline and Weeks 8(T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 20 years old Regular follow-up in the nephrology clinic Diagnosed with chronic kidney disease at stage 5 (or 5D) Expect to do the first autologous arteriovenous fistula surgery Exclusion Criteria: Not the first autologous arteriovenous fistula surgery Have undergone percutaneous transluminal angioplasty in the arm receiving autologous arteriovenous fistula Have undergone orthopedic disease-related surgery in the arm receiving autologous arteriovenous fistula Have been cardiovascular events within the past 3 months Have been heart function Left ventricular ejection fraction within the past 3 months <30%.
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei
State/Province
Taipei City
ZIP/Postal Code
112303
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Intelligent Exercise on Vascular Function, Grip Strength and Adherence in Patients With AVF After Surgery

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