Rectal Cancer Clinical Trial
— IleostimOfficial title:
Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.
The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage. I t is most often performed after a low anterior resection indicated for lower-middle rectal cancer. A second operation is required for closure, with a morbidity of about 25%. Many studies have been completed in order to detect possible risk factors - both patient-related and surgery-related - for complications in ileostomy closure surgery. Currently, there is a lack of research studies focused on the preoperative management of these patients. Our purpose is to reduce the complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus. Main objective: To assess whether efferent loop stimulation two weeks before ileostomy closure decreases the incidence of postoperative paralytic ileus.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | May 9, 2024 |
Est. primary completion date | December 9, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients over 18 years of age who undergo a scheduled protective ileostomy closure surgery, performed in rectal cancer surgery. All patients will follow a homogeneous protocol for testing the rectal anastomosis prior to closure, based on an opaque enema to rule out the presence of anastomotic leakage. Entry into the study does not affect the other surgical indications, in terms of time to ileostomy closure, type of operation or anaesthesia, or request for additional tests. Elective surgery. Patients who sign the informed consent document. Exclusion Criteria: - Patients undergoing simultaneous abdominal procedures at the time of ileostomy closure. History of protective ileostomy for a pathology other than rectal cancer. History of surgery in the ileal region. |
Country | Name | City | State |
---|---|---|---|
Spain | Jorge Arredondo | Leon |
Lead Sponsor | Collaborator |
---|---|
Universidad de León |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ileus | Presence of paralytic ileus (defined as intolerance to oral food on or after the third postoperative day, in the absence of clinical or radiological signs of obstruction, requiring placement of a nasogastric tube or associated with two of the following: nausea/vomiting, abdominal distention and the absence of flatus). | 1 month | |
Secondary | Hospital stay | Length of hospital stay | 1 month | |
Secondary | Time to tolerate regular diet | Time to tolerate regular diet | 1 month | |
Secondary | Time to first passage of flatus | Time to first passage of flatus | 1 month | |
Secondary | Time to first passage of stool | Time to first passage of stool | 1 month | |
Secondary | General morbidity | General morbidity [including anastomotic leak, surgical site infection (superficial, deep, organ space), other complications: urinary tract infection, pneumonia, postoperative acute kidney injury, deep vein thrombosis, pulmonary embolism, small bowel obstruction, myocardial infarction, stroke, reoperation and "other". | 6 months | |
Secondary | Postoperative continence | Grade of postoperative continence and incidence of anterior resection syndrome | 6 months | |
Secondary | Hospital readmission | Hospital readmission rate | 6 months |
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