drugset / Trial / NCT01082627

Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction

NCT01082627

Phase 4 Completed 44 enrolled Nanjing PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To demonstrate whether an early fixed Somatostatin treatment improves the complete recovery rate of early postoperative simple small bowel obstruction (EPSSBO) compared with the common daily practice Notes: 1. complete recovery= toleration of solid food+ flatus+ passage+ recovery of bowel movement. 2. common daily practice includes: * NPO (Nil per mouth), re-dehydration, TPN (Total Parenteral Nutrition) if needed. Check \& make sure stability of electrolytes daily. * GI (Gastro-Intestinal) depression via NGT (Naso-Gastric Tube) * Discontinue opiates, instead of NSAIDs. (Non-Steroidal Anti-Inflammatory Drugs) * Pro-dynamic drugs or other drugs which may interfere with GI (Gastro-Intestinal) movement eg. anti-histamines, anti-cholinergic, opiates, anti-depressives are not indicated. Secondary Objectives: To investigate whether an early fixed Somatostatin treatment will bring much benefit to EPSSBO pts compared with the common daily practice,for this purpose,the study will investigate the endpoints below.

Timeline

Start
2009-06
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatostatin Traditional medicine (herbal / TCM) 250 ug Intravenous