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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing PLA General Hospital
• Treatments: Somatostatin

Criteria

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.