Efficacia di ondansetron nel trattamento della sindrome post resezione anteriore bassa del retto: studio doppio cieco, randomizzato, farmaco-placebo

Drug: Ondansetron 4 MG;Drug: Placebo

Inclusion Criteria:

- Age = 18 years

- Patients willing and able to comply with the study procedures

- Female patients of childbearing potential must agree to use a reliable method of
contraception

- Written informed consent Patients who have undergone low anterior resection (LAR) for
rectal cancer in the last 2 years provided that at least 4 weeks have elapsed since
recanalization and 4 weeks have elapsed since any chemo- and/or radiotherapy

- Presence of functioning anastomosis

- Presence of significant LARS symptoms assessed by LARS Score

Exclusion Criteria:

- Known hypersensitivity or allergy to Ondansetron

- Previous Ondansetron antiemetic therapy completed less than 4 weeks before study entry

- Antitumor chemotherapy or radiotherapy completed less than 4 weeks before study entry

- Congenital long Q-T syndrome

- Ongoing treatment with drugs causing prolongation of the Q-T interval

- Uncorrected hypokalemia or hypomagnesemia

- Women who are pregnant or breast feeding or are willing to become pregnant during the
study

- Clinically significant concomitant disease states or anastomotic complications which
could impair the ability of the patient to participate in the trial

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc.