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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372007
First Posted: June 13, 2011
Last Update Posted: October 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose

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.


Condition Intervention Phase
Rectal Carcinoma Drug: Lanreotide Autogel 120mg Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • % 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. ]
    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.


Secondary Outcome Measures:
  • Evaluation of the Quality of life of the patient. [ Time Frame: This will be evaluated during a hospitalization of approximately 10 days. ]
    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. ]
    Patient observation to evaluate time of mobilisation after surgery. Evaluation of the results and the effect on the Health economy.


Enrollment: 24
Study Start Date: July 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lanreotide Autogel 120mg 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.
Placebo Comparator: Placebo 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372007


Locations
Belgium
Universital Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Ipsen
Investigators
Principal Investigator: Piet Pattyn, MD, PhD University Hospital, Ghent
  More Information

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01372007     History of Changes
Other Study ID Numbers: 2011/267
First Submitted: June 8, 2011
First Posted: June 13, 2011
Last Update Posted: October 7, 2016
Last Verified: October 2016

Keywords provided by University Hospital, Ghent:
Rectal carcinoma

Additional relevant MeSH terms:
Lanreotide
Angiopeptin
Antineoplastic Agents