A randomized clinical trial investigating LanreotIde For output reduction in patients with high-output Enterocutaneous fistula or enterostomie

Phase 3

Completed

Conditions: connection between gasrointesinal tract and the skin whereby losing many fluids and electrolytes
high out-put enterocutaneous fistula or high-output enterostomie
10017998

Registration Number: NL-OMON44776

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

All adult patients with a high-output fistula (> 500ml/day) or high-output enterostomie (<1500 ml/day) after gastro-intestinal, abdominal wall surgery will be registered from the moment are referred to our multi-disciplinary outpatient treatment team. ;Inclusion criteria for randomization:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Adult patients minimal 4 weeks after abdominal surgery
* Received minimal 2 weeks standard treatment
* High output small bowel fistula (>500ml/day) or enterostomy (>1500ml/day) for at least 3 consecutive days.
* The diagnosis of fistula origin and localization confirmed by CT/fistulography/ enteral contrast MRI.

Exclusion Criteria

Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Treatment with short-acting somatostatin (or analogues) in the last 2 weeks or with a long-acting somatostatine analogue in the last 2 months.
* Patients with high output pancreatic fistula after pancreatitis
* Patients with symptomatic gallbladder disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the number of responders in week 8. Definition of a<br /><br>responder is a decrease in output of >25% at week 8 compared with baseline<br /><br>output. Output will be assessed for 8 weeks or until surgery if within 8 weeks;<br /><br>in mL/24 hrs. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are days to full oral or enteral nutrition, change in need<br /><br>of intravenous fluid/TPN per week, time to reach the maximal effect in fistula<br /><br>output, percent reduction in total fistula or stoma output from pre<br /><br>randomisation, total number of days in hospital, changes in needed<br /><br>electrolytes (calcium, magnesium, potassium, phosphate, bicarbonate), wound<br /><br>care, quality of life (EQ-5D/qaly*s), analysis of costs, absolute fistula or<br /><br>stoma output volume at endpoint compared with output volume at randomisation.</p><br>