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NCT05752071
Gastrointestinal Stimulation as a Treatment of Postoperative Ileus Following Extensive Surgery
Conditions: Postoperative Ileus, Bowel Paralysis
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: University of Aarhus
Summary
The goal of this clinical trial is to investigate the effect of gastrointestinal stimulation with a pacemaker on the length of postoperative bowel paralysis in patients undergoing major abdominal surgery due to metastasizing colorectal cancer, appendiceal cancer or pseudomyxoma peritonei.The main question it aims to answer is if the length of postoperative ileus is reduced when the gastrointestinal tract is stimulated with a pacemaker.All participants will undergo cytoreductive surgery +/- heated intraperitoneal chemotherapy (the standard treatment for colorectal cancer, appendiceal cancer with peritoneal carcinomatosis or pseudomyxoma peritonei).
After surgery, but before the abdomen is closed a pace lead will be attached to the stomach, exteriorized trough the abdominal wall and connected to an external pacemaker.
The pacemaker is either turned on (experimental group) or turned off (control group).Furthermore, the patients are asked to ingest a SmartPill capsule two hours prior to surgery.
This will transmit information on gastrointestinal transit times and motility.After surgery, patients will be asked to fill out a diary on bowel movements once a day.
Eligibility Criteria
Inclusion Criteria:Patients planned for elective cytoreductive surgery with or without heated intraperitoneal chemotherapy due to either colorectal or appendiceal cancer or with peritoneal metastases or due to pseudomyxoma peritoneiWritten and orally informed consentOver 18 years of ageExclusion Criteria:Previous upper gastric or esophageal resectionPre-existent or creation of a stomaHistory of difficulties in swallowing or gastrointestinal stenosisImplanted or portable electrical medical device e.g.
cardiac pacemaker, defibrillator or infusion pump etc.Pregnant or breast-feeding women
Source: ClinicalTrials.gov (NCT05752071). StuddyBuddy aggregates publicly available trial information.