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

NCT01082627 | Completed Phase 4 DMC

• 1 other identifier: Nanjing Jinling Hospital
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Somatostatin small bowel obstruction

Outcome Measures

Primary Outcomes (1)

• Complete recovery rate of EPSSBO = (Num. of patients with complete recovery of EPSSBO per group/Total num. of patients per group) * 100

  14 days

Secondary Outcomes (6)

• Average recovery time

  14 days

• Re-surgery rate

  14 days

• Average NG (naso-gastric) aspirate volume

  14 days

• Average re-dehydration volume

  14 days

• Change of blood electrolytes

  14 days

Study Arms (2)

Somatostatin+common daily practice

EXPERIMENTAL

Drug: Somatostatin

common daily practice

PLACEBO COMPARATOR

Other: common daily practice

Interventions

Somatostatin DRUG

250ug/h,Continuous I.V. infusion,maximal 14 days

Also known as: Stilamin

Somatostatin+common daily practice

common daily practice OTHER

common daily practice

common daily practice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing PLA General Hospital: lead

Study Sites (1)

Nanjing PLAGH

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

Somatostatin

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 3, 2011

Record last verified: 2010-02

Locations

CN (1)