Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
Condition: Small Bowel Obstruction
MeSH terms: Intestinal Obstruction
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Somatostatin; common daily practice
Intervention type(s): Drug; Other
Intervention description(s): 250ug/h,Continuous I.V. infusion,maximal 14 days; common daily practice
Other intervention name(s): Stilamin
Intervention MeSH terms: Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Somatostatin small bowel obstruction