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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082627
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : August 3, 2011
Information provided by:
Nanjing PLA General Hospital

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


  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.

Condition or disease Intervention/treatment Phase
Small Bowel Obstruction Drug: Somatostatin Other: common daily practice Phase 4

Detailed Description:
  1. Study Design:

    This is a multi-centers, open label, randomized study , and will enroll 80 EPSSBO patients, who will be assigned to two groups randomly. All the inclusive patients will be consistent with the diagnosis of EPSSBO, and the mechanic SBO or the strangulating SBO will be ruled out in advance.

    The inclusive patients will be assigned to two groups as follow(ratio 3:1)

    • Arm A: Somatostatin+common daily practice(60).
    • Arm B: common daily practice only(20).
  2. Total number of subjects:80 EPSSBO patients.
  3. Schedule of visits and assessments,The following assessments will be performed.

    • Pre-screening:informed consent,demographic data,EPSSBO diagnosis.
    • Screening
    • Daily visit:
    • Weekly visit:
    • End of study visit:
  4. Statistical methods

    • As this will be a pilot study, no formal statistical calculations were carried out and the sample size was estimated as 80 EPSSBO subjects in a 3:1 ratio of active to control subjects i.e. 60 for Stilamin+ common daily practice and 20 for common daily practice only.
    • The primary endpoint of the complete recovery rate will be estimated for both treatment groups, with 95% confidence intervals. The difference in the proportions between the treatment groups will also be estimated and treatment comparisons will be performed using a chi-square test. All statistical tests will be 2-tailed with a significance level of 0.05.
    • Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
    • Continuous variables will be analyzed using an analysis of variance (ANOVA) model with effect for treatment only. The data will be checked for normality. If the distributions are normal, parametric techniques will be used. If the data are not normally distributed, non parametric techniques will be used. These assumptions will also apply to the primary endpoint i.e. use of non-parametric tests if necessary. All statistical tests will be 2-tailed with a significance level of 0.05.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multi-centers, Investigator Sponsored, Randomized Controlled Trial Towards Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
Study Start Date : June 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Somatostatin+common daily practice Drug: Somatostatin
250ug/h,Continuous I.V. infusion,maximal 14 days
Other Name: Stilamin

Placebo Comparator: common daily practice Other: common daily practice
common daily practice

Primary Outcome Measures :
  1. Complete recovery rate of EPSSBO = (Num. of patients with complete recovery of EPSSBO per group/Total num. of patients per group) * 100 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Average recovery time [ Time Frame: 14 days ]
  2. Re-surgery rate [ Time Frame: 14 days ]
  3. Average NG (naso-gastric) aspirate volume [ Time Frame: 14 days ]
  4. Average re-dehydration volume [ Time Frame: 14 days ]
  5. Change of blood electrolytes [ Time Frame: 14 days ]
  6. Degree of symptom and sign relief [ Time Frame: 14 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082627

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China, Jiangsu
Nanjing PLAGH
Nanjing, Jiangsu, China
Sponsors and Collaborators
Nanjing PLA General Hospital
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Responsible Party: NLi, Nanjing Jinling Hospital Identifier: NCT01082627    
Other Study ID Numbers: Nanjing Jinling Hospital
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: February 2010
Keywords provided by Nanjing PLA General Hospital:
Somatostatin small bowel obstruction
Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs