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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01082627 on ClinicalTrials.gov