Overview
Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
Status:
Completed
Completed
Trial end date:
2010-11-01
2010-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Nanjing PLA General HospitalTreatments:
SomatostatinCriteria
Inclusion Criteria:- Patient has given written informed consent before any study-related activities are
carried out.
- Males and females,aged 18-70.
- Recent open abdominal surgery history.
- Having the following symptoms or signs after 5 days of index operation: abdominal
distention + inability to pass flatus + inability to passage + weak or absent bowel
sound.
- X-ray:paucity of bowel gas,0-1 air-fluid level.
- CT:intestinal wall edema/thickness,no mechanic obstruction
Exclusion Criteria:
- After laparoscopic surgery.
- Recent drug history of
anti-histamines,anti-cholinergic,anti-depressives,post-operative usage of opiates.
- Any of below:severe abdominal pain,colic,peritoneal sign,hig-pitched bowel
sound,T>38℃,tachycardia,bradycardia,WBC>12000/ul,X-ray≥2 air-fluid levels,CT:mechanic
obstruction.
- Any of below: Abdominopelvic abscess,Anastomotic leaks,
Appendicitis,Cholecystitis,Hemoperitoneum or retroperitoneal hemorrhage, Hypokalemia,
Hypomagnesemia, Pancreatitis, Sepsis.Uremia.
- Severe heart failure(NYHA III and above).
- History of arrhythmia or syncope.
- ECG QTc >0.44s.
- Severe renal function insufficiency (Calculated Creatinine Clearance Rate (Ccr)
<30ml/min).
- Severe Liver function insufficiency(CHILD B~C).
- Hyper or hypothyroidism intracranial GH-secreting tumor.
- Brittle DM.
- Pregnancy.
- Allergy to any ingredient of Stilamin.
- History of significant neurologic or psychiatric disorders including dementia,
seizures, bipolar disorder.
- Medical or psychological condition that would not permit the patient to complete the
study or sign the informed consent.