Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
Condition: Rectal Carcinoma
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal
      lymph nodes within the mesorectal envelope. It is becoming universally recognized and
      accepted as the standard technique for surgical excision of rectum carcinomas. TME results in
      lowest rates of local recurrence, especially when combined with pre-operative
      chemo-radiotherapy.

      Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be
      important. The quick decrease of this drainage will enable the early mobilisation of the
      patient and may shorten the time of hospitalization. If this decrease in fluid production can
      be achieved, it will have a positive effect on the Quality of Life of the patient and will
      ensure health economic savings by reduction of hospitalization time and resources.

      Somatostatin analogues have shown to be able to decrease the secretion of numerous types of
      bodily fluids.

      The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the
      fluid discharge in patients that underwent a TME for rectumcarcinoma.

      Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid
      discharge in the drain of the patient that underwent a total mesorectum excision (TME) for
      rectal carcinoma. Patient planned to have a TME will be asked to participate in the study.
      When they have provided written informed consent, they will be randomized 1:1 to receive
      either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily
      post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication or placebo
      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. If the patient has a hematocrit >10% in his drain fluid for a period of
      5 days, this patient can not be randomized.
    


Intervention name(s): Lanreotide Autogel 120mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Lanreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Rectal carcinoma