Colorectal Neoplasms
Conditions
Interventions
This study will be a two arms open-label randomized controlled clinical trial. Patients will be recruited from a public teaching hospital specializing in oncological surgery and all procedures will be
E04.210.338.508
Sponsors
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients (older than 18 years); with rectal cancer in clinical stages cT3/4Nx or cTxN+; that maybe treated with neoadjuvant chemoradiotherapy; anda submitted to laparoscopic or robotic total mesorectal excision, and submitted to loop protection ileostomy; And also patients who are not undergoing systemic chemotherapy
Exclusion criteria
Exclusion criteria: Patients who refuse to participate in the study; Patients with a history or suspicion of inflammatory bowel disease; Pregnant patients; Patients who have any contraindication for general anesthesia or surgical intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that after ileostomy closure surgery in patients undergoing stimulation of the dysfunctional intestinal loop, there is an improvement in intestinal transit (lower rate of adynamic ileus), verified through clinical reports provided by patients;It is expected that after ileostomy closure surgery in patients undergoing stimulation of the dysfunctional intestinal loop, patients will present a good acceptance of the diet early, that is, it is expected that they will not present symptoms with nausea or vomiting when eating.;It is expected that after ileostomy closure surgery in patients undergoing stimulation of the dysfunctional intestinal loop, patients will have early evacuation, that is, 72 hours after the surgical procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that after ileostomy closure surgery in patients undergoing stimulation of the dysfunctional intestinal loop, they will show an improvement in stool consistency, increasingly consistent with the passing of days, which will be measured using the Bristol scale. , in addition to a decrease in the number of bowel movements per day, leading to a lower rate of fecal incontinence (Wexner Score);It is expected that patients undergoing stimulation of the dysfunctional intestinal loop (excluded) before the closure of the ileostomy will have a shorter hospital stay, precisely because they have improved food acceptance and early evacuation, leading to a lower cost inherent to the procedure;Patients undergoing stimulation of the defunctionalized (excluded) loop prior to ileostomy closure are expected to have a lower rate of colitis visualized by rectoscopy using the Harig scoring system as a basis;Since an improvement in stool consistency, a lower frequency of bowel movements per day and a lower rate of fecal incontinence are expected in patients who undergo stimulation of the defunctionalized (excluded) loop prior to ileostomy closure, it is also expected, therefore, that there is an improvement in their quality of life, assessed through a questionnaire (SF-36) | — |
Countries
Brazil
Contacts
Public ContactFrancisco Tustumi
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Outcome results
None listed