Postoperative Electrical Muscle Stimulation (POEMS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-08-01

Brief Summary

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Patients lose a significant amount of muscle following major abdominal surgery. This is partly due to a catabolic response to the surgical insult and inflammation, but is also probably due to a lack of muscle use secondary to immobility.

This study will aim to assess whether some or even all of postoperative muscle loss in the upper leg muscle group is preventable through electrical muscle stimulation to mimic physical activity.

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Detailed Description

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Following major gastrointestinal surgery patients may loose around 6 % of their skeletal muscle mass in the first 5 days. Whilst some of this loss is as a result of inflammation and starvation, some is due to muscle disuse.

Studies have shown that patients spend 96% of their time being sedentary in the first 5 days following major abdominal surgery and by day 5 are still taking a median of less than 500 steps per day. Studies of healthy volunteers who undergo similar muscle disuse loose approximately 3.5% of skeletal muscle mass over the same time period, indicating that around half of postoperative muscle loss may be due to immobility.

Through the use of electrical muscle stimulation, this study will aim to mimic high levels of exercise in the quadriceps of patients who have undergo major gastrointestinal surgery to see whether this reduces or prevents muscle loss. Patients muscles will be measured using ultrasound and DXA and neuromuscular function will be measured using electromyography.

Conditions

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Muscle Atrophy Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single centre pilot study (randomised internal control trial)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

ultrasound images, DXA scans and EMG results will be given coded labeling by a separate researcher so that investigator analysing results will be blinded to whether scans / EMG results are from intervention or control leg, or start of finish.

Study Groups

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EMG leg

Quadriceps muscle group of postoperative patients randomly selected leg which will undergo electrical muscle stimulation for upto 2 hours on each postoperative day

Group Type EXPERIMENTAL

Electrical Muscle stimulation

Intervention Type DEVICE

Electrical muscle stimulation

Control leg

Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electrical Muscle stimulation

Electrical muscle stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing major segmental colonic resections or gastric/oesophageal resection
* Sufficient mobility and fitness to complete normal enhanced recovery protocols following surgery
* Ability to give informed consent

Exclusion Criteria

* Pre-existing neuromuscular disease (including parkinson's disease)
* Pacemaker, implantable cardiac defibrillator or other implanted nerve stimulator device
* Metalwork in both upper legs
* Dementia
* Inability to give informed consent
* Disability preventing normal mobilisation after surgery
* Symptomatic peripheral vascular disease
* Chronic kidney failure of chronic heart failure
* Intubation for \> 24 hours post operation
* Return to theatre for surgical complication within first 5 days post operation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No