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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01372007
First received: June 8, 2011
Last updated: January 29, 2013
Last verified: January 2013

June 8, 2011
January 29, 2013
July 2011
December 2013   (final data collection date for primary outcome measure)
% reduction in drain fluid volume over a period of 5 days post study treatment administration in both arms. [ Time Frame: Drain fluid will be checked every day with a minimum of 5 days or until the drain is removed. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01372007 on ClinicalTrials.gov Archive Site
  • Evaluation of the Quality of life of the patient. [ Time Frame: This will be evaluated during a hospitalization of approximately 10 days. ] [ Designated as safety issue: No ]
    Patient observation to evaluate Quality of life of the patient, and time of mobilisation after surgery. Evaluation of the results and the effect on the Health economy.
  • Evaluation of the time of mobilisation after surgery. [ Time Frame: This will be evaluated during a hospitalization of approximately 10 days. ] [ Designated as safety issue: No ]
    Patient observation to evaluate time of mobilisation after surgery. Evaluation of the results and the effect on the Health economy.
Same as current
Not Provided
Not Provided
 
Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Rectal Carcinoma
  • 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.
  • Experimental: Lanreotide Autogel 120mg
    Intervention: Drug: Lanreotide Autogel 120mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
February 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male and female patients
  • 18-75 years
  • written informed consent to participate the study
  • scheduled to have a total mesorectal excision (TME) for rectumcarcinoma

Exclusion Criteria:

  • patients with a known intolerance for somatostatin analogues, lanreotide or any of it's excipients
  • patients younger than 18 years
  • patients unable to provide written informed consent
  • patients who received somatostatin or any of it's analogues the last 30 days before the start of the study
  • Pregnant and breast-feeding women
  • Women not using contraception
Both
18 Years to 75 Years
No
Contact: Piet Pattyn, Md, PhD piet.pattyn@ugent.be
Contact: Saskia De Groote saskia.degroote@uzgent.be
Belgium
 
NCT01372007
2011/267
No
University Hospital, Ghent
University Hospital, Ghent
Ipsen
Principal Investigator: Piet Pattyn, MD, PhD University Hospital, Ghent
University Hospital, Ghent
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP