Small Bowel ObstructionPhase 4NCT01082627
Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
A Phase 4 study testing Somatostatin and common daily practice in people with Small Bowel Obstruction, run by Nanjing PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- Somatostatin and common daily practice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
- CT:intestinal wall edema/thickness,no mechanic obstruction
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multi-centers, Investigator Sponsored, Randomized Controlled Trial Towards Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
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
Read more
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.
Read the 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.
- Conditions
- Small Bowel Obstruction
- Being tested
- Somatostatin, common daily practice
- Keywords
- Somatostatin small bowel obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Also called Stilamin
250ug/h,Continuous I.V. infusion,maximal 14 days
common daily practiceOther
common daily practice
| Study group | Role | What they receive |
|---|---|---|
| Somatostatin+common daily practice | Experimental | Not described Receives: Drug: Somatostatin |
| common daily practice | Placebo comparator | Not described Receives: Other: common daily practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete recovery rate of EPSSBO = (Num. of patients with complete recovery of EPSSBO per group/Total num. of patients per group) * 100
Measured: 14 days
Secondary outcomes (6)
Average recovery time
Measured: 14 days
Re-surgery rate
Measured: 14 days
Average NG (naso-gastric) aspirate volume
Measured: 14 days
Average re-dehydration volume
Measured: 14 days
Change of blood electrolytes
Measured: 14 days
Degree of symptom and sign relief
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing PLA General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082627
- Sponsor's protocol ID
- Nanjing Jinling Hospital
- Status last verified
- Feb 2010
- First submitted
- 5 Mar 2010
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-centers, Investigator Sponsored, Randomized Controlled Trial Towards Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT01082627
- Acronym / sponsor ID
- Nanjing Jinling Hospital
- Conditions
- Small Bowel Obstruction
- Keywords
- Somatostatin small bowel obstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatostatin+common daily practice | Experimental | Drug: Somatostatin |
| common daily practice | Placebo comparator | Other: common daily practice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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）.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatostatinAlso: Stilamin250ug/h,Continuous I.V. infusion,maximal 14 days | Drug | Somatostatin+common daily practice |
| common daily practicecommon daily practice | Other | common daily practice |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somatostatin and common daily practice in people with Small Bowel Obstruction, run by Nanjing PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2011.