Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Rectal Carcinoma
Interventions
DRUG

Lanreotide Autogel 120mg

Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are \<10%, study medication (0.246mg lanreotide base/mg solution) will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards.

DRUG

Placebo

Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are \<10%, placebo (Sodiumchloride 0,9% 1 ampoule) will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards.

Trial Locations (1)

9000

Universital Hospital Ghent, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ipsen

INDUSTRY

lead

University Hospital, Ghent

OTHER