Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
NCT01082627 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2011-08-03
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.
Conditions
- Small Bowel Obstruction
Interventions
- DRUG
-
Somatostatin
250ug/h,Continuous I.V. infusion,maximal 14 days
- OTHER
-
common daily practice
common daily practice
Sponsors & Collaborators
-
Nanjing PLA General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2010-11-30
- Completion
- 2010-11-30
Countries
- China
Study Locations
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