Postoperative Electrical Muscle Stimulation Two

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nottingham

About this trial

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 perform physical activities, and reduce independence and overall health. Muscle mass loss occurs very quickly (i.e., within a few days) after surgery.

The investigators previous work has shown that neuromuscular electrical stimulation (NMES) of the thigh muscles on one side of the body can help maintain muscle mass and strength on the stimulated side after surgery. Since then, additional work has been carried out to find the most effective form of stimulation to build muscle.

The current study aims to use this refined stimulation protocol in a clinical trial on the wards after major abdominal surgery. The intervention will involve delivering stimulation to both thighs in the few days after surgery, so that the investigators can assess whether this stimulation can preserve muscle mass and strength, and also, patients' ability to perform physical activities after surgery. In addition, the study will aim to find out whether any benefit provided by electrical stimulation can be increased further by taking a protein supplement at the same time.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Neuromuscular Electrical Stimulation
  • Protein supplement drink

Treatment groups

45 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Nottingham

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Collaborator