Influence of Somatuline Autogel [amount hidden] on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

What Was Tested

The trial (phase 3) is built around Lanreotide.

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.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female patients. Written informed consent to participate the study. Scheduled to have a total mesorectal excision (TME) for rectumcarcinoma.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Lanreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Lanreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2011-07 with completion listed for 2014-12.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Evaluation of the Quality of life of the patient and Evaluation of the time of mobilisation after surgery.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lanreotide compound page, all human trials.