Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma |
- % 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.
- 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Piet Pattyn, Md, PhD | piet.pattyn@ugent.be | |
| Contact: Saskia De Groote | saskia.degroote@uzgent.be |
| Belgium | |
| Universital Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Principal Investigator: Piet Pattyn, PhD, MD | |
| Sub-Investigator: Inge Vandenbroucke | |
| Sub-Investigator: Saskia De Groote | |
| Principal Investigator: W. Ceelen, PhD, MD | |
| Principal Investigator: Y. Van Nieuwenhove, PhD, MD | |
| Principal Investigator: D. Van de Putte, PhD, MD | |
| Principal Investigator: | Piet Pattyn, MD, PhD | University Hospital, Ghent |
More Information
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01372007 History of Changes |
| Other Study ID Numbers: | 2011/267 |
| Study First Received: | June 8, 2011 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Belgium: Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by University Hospital, Ghent:
|
Rectal carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Rectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Lanreotide Angiopeptin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013