Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
This study has been completed.
Sponsor:
Nanjing PLA General Hospital
Information provided by:
Nanjing PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01082627
First received: March 5, 2010
Last updated: August 2, 2011
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Bowel Obstruction |
Drug: Somatostatin Other: common daily practice |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 |
Resource links provided by NLM:
Further study details as provided by Nanjing PLA General Hospital:
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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average recovery time [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Re-surgery rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Average NG (naso-gastric) aspirate volume [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Average re-dehydration volume [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Change of blood electrolytes [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Degree of symptom and sign relief [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | June 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Somatostatin+common daily practice |
Drug: Somatostatin
250ug/h,Continuous I.V. infusion,maximal 14 days
Other Name: Stilamin
|
| Placebo Comparator: common daily practice |
Other: common daily practice
common daily practice
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | NLi, Nanjing Jinling Hospital |
| ClinicalTrials.gov Identifier: | NCT01082627 History of Changes |
| Other Study ID Numbers: | Nanjing Jinling Hospital |
| Study First Received: | March 5, 2010 |
| Last Updated: | August 2, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Nanjing PLA General Hospital:
|
Somatostatin small bowel obstruction |
Additional relevant MeSH terms:
|
Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Somatostatin |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013