Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
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
- complete recovery= toleration of solid food+ flatus+ passage+ recovery of bowel movement.
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.
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.
|Small Bowel Obstruction||Drug: Somatostatin Other: common daily practice||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- 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 ]
- Average recovery time [ Time Frame: 14 days ]
- Re-surgery rate [ Time Frame: 14 days ]
- Average NG (naso-gastric) aspirate volume [ Time Frame: 14 days ]
- Average re-dehydration volume [ Time Frame: 14 days ]
- Change of blood electrolytes [ Time Frame: 14 days ]
- Degree of symptom and sign relief [ Time Frame: 14 days ]
|Study Start Date:||June 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Experimental: Somatostatin+common daily practice||
250ug/h,Continuous I.V. infusion,maximal 14 days
Other Name: Stilamin
|Placebo Comparator: common daily practice||
Other: common daily practice
common daily practice
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).
- Total number of subjects:80 EPSSBO patients.
Schedule of visits and assessments,The following assessments will be performed.
- Pre-screening:informed consent,demographic data,EPSSBO diagnosis.
- Daily visit:
- Weekly visit：
- End of study visit：
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082627
|Nanjing, Jiangsu, China|