Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
Primary Purpose
Small Bowel Obstruction
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Somatostatin
common daily practice
Sponsored by
About this trial
This is an interventional treatment trial for Small Bowel Obstruction focused on measuring Somatostatin small bowel obstruction
Eligibility Criteria
Inclusion Criteria:
- 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.
- CT:intestinal wall edema/thickness,no mechanic obstruction
Exclusion Criteria:
- 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.
- Any of below: Abdominopelvic abscess,Anastomotic leaks, Appendicitis,Cholecystitis,Hemoperitoneum or retroperitoneal hemorrhage, Hypokalemia, Hypomagnesemia, Pancreatitis, Sepsis.Uremia.
- Severe heart failure(NYHA III and above).
- History of arrhythmia or syncope.
- ECG QTc >0.44s.
- Severe renal function insufficiency (Calculated Creatinine Clearance Rate (Ccr) <30ml/min).
- Severe Liver function insufficiency(CHILD B~C).
- Hyper or hypothyroidism intracranial GH-secreting tumor.
- Brittle DM.
- Pregnancy.
- Allergy to any ingredient of Stilamin.
- History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder.
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
Sites / Locations
- Nanjing PLAGH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Somatostatin+common daily practice
common daily practice
Arm Description
Outcomes
Primary Outcome Measures
Complete recovery rate of EPSSBO = (Num. of patients with complete recovery of EPSSBO per group/Total num. of patients per group) * 100
Secondary Outcome Measures
Average recovery time
Re-surgery rate
Average NG (naso-gastric) aspirate volume
Average re-dehydration volume
Change of blood electrolytes
Degree of symptom and sign relief
Full Information
NCT ID
NCT01082627
First Posted
March 5, 2010
Last Updated
August 2, 2011
Sponsor
Nanjing PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01082627
Brief Title
Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
Official Title
Prospective, Multi-centers, Investigator Sponsored, Randomized Controlled Trial Towards Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nanjing PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
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.
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
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).
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.
Screening
Daily visit:
Weekly visit:
End of study visit:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction
Keywords
Somatostatin small bowel obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Somatostatin+common daily practice
Arm Type
Experimental
Arm Title
common daily practice
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Somatostatin
Other Intervention Name(s)
Stilamin
Intervention Description
250ug/h,Continuous I.V. infusion,maximal 14 days
Intervention Type
Other
Intervention Name(s)
common daily practice
Intervention Description
common daily practice
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Average recovery time
Time Frame
14 days
Title
Re-surgery rate
Time Frame
14 days
Title
Average NG (naso-gastric) aspirate volume
Time Frame
14 days
Title
Average re-dehydration volume
Time Frame
14 days
Title
Change of blood electrolytes
Time Frame
14 days
Title
Degree of symptom and sign relief
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
CT:intestinal wall edema/thickness,no mechanic obstruction
Exclusion Criteria:
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.
Any of below: Abdominopelvic abscess,Anastomotic leaks, Appendicitis,Cholecystitis,Hemoperitoneum or retroperitoneal hemorrhage, Hypokalemia, Hypomagnesemia, Pancreatitis, Sepsis.Uremia.
Severe heart failure(NYHA III and above).
History of arrhythmia or syncope.
ECG QTc >0.44s.
Severe renal function insufficiency (Calculated Creatinine Clearance Rate (Ccr) <30ml/min).
Severe Liver function insufficiency(CHILD B~C).
Hyper or hypothyroidism intracranial GH-secreting tumor.
Brittle DM.
Pregnancy.
Allergy to any ingredient of Stilamin.
History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder.
Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
Facility Information:
Facility Name
Nanjing PLAGH
City
Nanjing
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
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Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
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