Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rectal Carcinoma
Intervention: Lanreotide Autogel 120mg (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s): Piet Pattyn, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
Overall contact: Piet Pattyn, Md, PhD, Email: piet.pattyn@ugent.be
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.
Clinical Details
Official title: Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: % reduction in drain fluid volume over a period of 5 days post study treatment administration in both arms.
Secondary outcome: Evaluation of the Quality of life of the patient.Evaluation of the time of mobilisation after surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Piet Pattyn, Md, PhD, Email: piet.pattyn@ugent.be
Universital Hospital Ghent, Ghent 9000, Belgium; Recruiting Piet Pattyn, PhD, MD, Principal Investigator Inge Vandenbroucke, Sub-Investigator Saskia De Groote, Sub-Investigator W. Ceelen, PhD, MD, Principal Investigator Y. Van Nieuwenhove, PhD, MD, Principal Investigator D. Van de Putte, PhD, MD, Principal Investigator
Additional Information
Starting date: July 2011
Last updated: June 2, 2015
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