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

2014-08-27 03:15:23 | BioPortfolio

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.

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

Conditions

Small Bowel Obstruction

Intervention

Somatostatin, common daily practice

Status

Not yet recruiting

Source

Nanjing PLA General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:23-0400

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Medical and Biotech [MESH] Definitions

A potent, long-acting synthetic SOMATOSTATIN octapeptide analog that inhibits secretion of GROWTH HORMONE and is used to treat hormone-secreting tumors; DIABETES MELLITUS; HYPOTENSION, ORTHOSTATIC; HYPERINSULINISM; hypergastrinemia; and small bowel fistula.

Cell surface proteins that bind somatostatin and trigger intracellular changes which influence the behavior of cells. Somatostatin is a hypothalamic hormone, a pancreatic hormone, and a central and peripheral neurotransmitter. Activated somatostatin receptors on pituitary cells inhibit the release of growth hormone; those on endocrine and gastrointestinal cells regulate the absorption and utilization of nutrients; and those on neurons mediate somatostatin's role as a neurotransmitter.

A 28-amino acid peptide with the same biological activities of somatostatin-14 but with a 14-amino acid extension at the N-terminal. SRIF-28 is the major form of somatostatin in the GASTROINTESTINAL TRACT.

The hindering of output from the STOMACH into the SMALL INTESTINE. This obstruction may be of mechanical or functional origin such as EDEMA from PEPTIC ULCER; NEOPLASMS; FOREIGN BODIES; or AGING.

Endocrine cells found throughout the GASTROINTESTINAL TRACT and in islets of the PANCREAS. D cells secrete SOMATOSTATIN that acts in both an endocrine and paracrine manner. Somatostatin acts on a variety of tissues including the PITUITARY GLAND; gastrointestinal tract; pancreas; and KIDNEY by inhibiting the release of hormones, such as GROWTH HORMONE; GASTRIN; INSULIN; and RENIN.

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