Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

% reduction in drain fluid volume over a period of 5 days post study treatment administration in both arms.

Outcome Description:

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.

Outcome Time Frame:

Drain fluid will be checked every day with a minimum of 5 days or until the drain is removed.

Safety Issue:

No

Principal Investigator

Piet Pattyn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Ethics Committee

Study ID:

2011/267

NCT ID:

NCT01372007

Start Date:

July 2011

Completion Date:

February 2014

Related Keywords:

• Rectal Carcinoma
• Rectal carcinoma
• Carcinoma
• Rectal Neoplasms