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

What Was Tested

In this phase 4 trial, researchers set out to test Somatostatin.

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.

It had two arms (groups): Somatostatin+common daily practice (experimental) and common daily practice (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

The registry lists 44 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Somatostatin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-06 with completion listed for 2010-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 6 secondary outcomes, for example Average recovery time, Re-surgery rate, Average NG (naso-gastric) aspirate volume, Average re-dehydration volume, Change of blood electrolytes and Degree of symptom and sign relief.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Somatostatin in 44 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page, all human trials.