Status:
NOT_YET_RECRUITING
Postoperative Electrical Muscle Stimulation Two
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
University Hospitals of Derby and Burton NHS Foundation Trust
Conditions:
Surgery
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Undesirable loss of skeletal muscle mass (atrophy) is a common feature of many diseases as well as ageing, bed rest and physical inactivity. Losing muscle can lead to a reduction in one's ability to p...
Detailed Description
The main objective of this trial is to assess whether neuromuscular stimulation (NMES) can minimise muscle loss following abdominal surgery for cancer; and whether such effect is further improved by s...
Eligibility Criteria
Inclusion
- Adult patients (age 18 or over at the time of diagnosis made at MDT (multi-disciplinary team meeting)
- MDT outcome of colorectal or gastric cancer or non-invasive neoplasia (tissue-proven, or radiologically diagnosed and clinically suspected) with the intention to treat with curative abdominal surgery
- Agreed management plan for open or minimally invasive (laparoscopic or robot assisted) segmental abdominal (colonic or gastric) resection at the Royal Derby Hospital
- Sufficient mobility and fitness to complete normal ERAS (enhanced recovery after surgery) protocols following surgery
- Basic conversational spoken English language
- Ability to give informed consent
Exclusion
- Upper GI (gastrointestinal) cancer requiring thoracotomy/thoracoscopy
- Pre-existing neuromuscular disease (including Parkinsons disease)
- Pacemaker, implantable cardiac defibrillator or other implanted nerve stimulator device
- Metal prostheses or other metal-work in either upper legs (hip/knee/femur)
- Dementia or other cognitive problem or language barrier causing an inability to follow instructions and operate NMES machine
- Inability to give informed consent
- Disability preventing completion of ERAS after surgery (requiring Zimmer frame/wheeled frame/wheelchair to mobilise or bed-bound)
- Peripheral vascular disease
- Epilepsy
- Pre-existing diagnosis of chronic kidney disease or estimated glomerular filtration rate \<60 on screening visit
- Pre-existing diagnosis of liver disease
- Intubation or intensive care admission during study period (between day 0-5 post-op); (surgical high dependency unit patients will be included)
- Return to theatre for surgical complication within first 5-days post operation
- History of rhabdomyolysis
- Pregnancy
- Deep vein thrombosis within past 6-months
- Allergy to whey protein
- Patient refusal of whey protein products on grounds of dietary requirements or intolerance
- Participating in another clinical trial concurrently or within the last 6 months
- Known infection with blood borne virus
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06964438
Start Date
May 1 2025
End Date
July 1 2026
Last Update
May 9 2025
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