New hope for ostomy patients: drug cuts dangerous fluid loss

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and Female patients ≥ 18 years old ; * Patients who underwent an intestinal surgery with enterostomy repair in the three weeks preceding the inclusion ; * Patients with high-output ileostomy or jejunostomy \> 1000 ml/24h ; * Patients with failure of treatment combining oral fluid restriction and loperamide (up to 8 capsules/24h) +/- codeine syrup (10 mg x 3/24h) during 5 days ; * Patients who gave its written informed consent to participate to the study ; * Patients affiliated to a social insurance regime. Exclusion Criteria: * Male and Female patients \< 18 years old ; * Patients who did not give its written informed consent to participate to the study ; * Patients who received somatostatin analogues during the month before inclusion ; * Patients with symptomatic cholelithiasis or acute or chronic pancreatitis ; * Patients with uncontrolled diabetes (with HbA1c (glycated hemoglobin) \> 8%) ; * Patients who are hypothyroid and not on adequate replacement therapy ; * Patients who have congestive heart failure (NYHA (New York Heart Association) Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, advanced heart block or a history of clinically significant bradycardia or acute myocardial infarction within the 6 months preceding randomization ; * Patients with history of syncope or family history of idiopathic sudden death ; * Patients with screening or baseline (predose) : QT interval corrected for heart rate using Fridericia's correction (QTcF) QTcF \> 450 msec (male), QTcF \> 460 msec (female) (QT interval corrected for heart rate using Fridericia's correction) ; * Patients with not corrected hypokalaemia and/or hypomagnesaemia ; * Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with alanine transaminase/aspartate transaminase (ALT/AST) \> 2 x Upper Limit of Normal (ULN), serum bilirubin \> 2 x ULN ; * Patients with Child-Pugh C cirrhosis ; * Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control ; * Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or activated partial thromboplastin time (APTT) ; * Patients with known hypersensitivity to somatostatin analogues or any other component of the pasireotide LAR ; * Patients under guardianship ; * Patients nonaffiliated to a social insurance regime.