This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Small Bowel Obstruction

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

Sponsored by Nanjing PLA General Hospital

About this trial

Last updated 14 years ago

Study ID

Nanjing Jinling Hospital

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 15 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status