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

Small Bowel Obstruction Clinical Trial

Official title: Prospective, Multi-centers, Investigator Sponsored, Randomized Controlled Trial Towards Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

• NCT number: NCT01082627
• Study type: Interventional
• Source: Nanjing PLA General Hospital
• Status: Completed
• Phase: Phase 4
• Start date: June 2009
• Completion date: November 2010