Gastrointestinal Stimulation as a Prevention of Postoperative Ileus Following Extensive Surgery (STIMULATE)‐ a Pilot Feasibility Study
Anne K. Martensen, Thomas Nielsen, Anne Bodilsen, Mette M. Sørensen, Lene H. Iversen, Jonas A. FunderABSTRACT
Background
Postoperative ileus (POI) is a common complication following major abdominal surgery. Currently, limited treatment options for POI exist. Recent preclinical studies show that direct electrical stimulation of the gastrointestinal tract may prevent POI. The aim was to evaluate the safety and feasibility of direct electrical stimulation of the stomach in patients undergoing major abdominal surgery.
Method
A single‐center, randomized blinded feasibility study conducted at Aarhus University Hospital, Denmark. Patients who underwent cytoreductive surgery with heated intraperitoneal chemotherapy for low‐grade appendiceal mucinous neoplasm or colorectal or appendiceal cancer with peritoneal metastases were eligible. After surgery, a pace lead was attached to the stomach and connected to an external stimulator (Enterra Medical, Minneapolis, USA). Participants were randomized, 1:1, to an intervention group (stimulator on) or a control group (stimulator off). The primary outcome was completion of the intervention as a measure of tolerability.
Results
Of 63 eligible patients, 27 consented to participate (43%). Seven patients were excluded perioperatively. Twenty patients were randomized. Nineteen patients were eligible for analysis, 10 in the intervention group and 9 in the control group. The treatment was well tolerated. The completion rate was 8/10 in the intervention group and 9/10 in the control group. Abdominal muscle spasms were the most common adverse events reported in both groups.
Conclusion
Electrical stimulation appears safe, feasible and well tolerated. This study supports further clinical studies on electrical stimulation as prevention of POI.
Trial Registration
The study was registered at