Small Bowel Obstruction Clinical Trial
Official title:
Prospective, Multi-centers, Investigator Sponsored, Randomized Controlled Trial Towards Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel Obstruction
Verified date | February 2010 |
Source | Nanjing PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Nanjing PLAGH | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete recovery rate of EPSSBO = (Num. of patients with complete recovery of EPSSBO per group/Total num. of patients per group) * 100 | 14 days | No | |
Secondary | Average recovery time | 14 days | No | |
Secondary | Re-surgery rate | 14 days | No | |
Secondary | Average NG (naso-gastric) aspirate volume | 14 days | No | |
Secondary | Average re-dehydration volume | 14 days | No | |
Secondary | Change of blood electrolytes | 14 days | No | |
Secondary | Degree of symptom and sign relief | 14 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02065661 -
Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)
|
N/A | |
Completed |
NCT05517057 -
Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction
|
||
Not yet recruiting |
NCT05864378 -
POCUS for Small Bowel Obstruction in the ED: a Retrospective Study
|
||
Terminated |
NCT03573921 -
Gastrografin for Treating Small Bowel Obstruction in Children
|
Phase 2/Phase 3 | |
Recruiting |
NCT05315765 -
Development of a Patient Reported Outcome Measure for GastroIntestinal Recovery
|
||
Not yet recruiting |
NCT01934283 -
Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
|
N/A | |
Not yet recruiting |
NCT04001985 -
Nasogastric Tube Clamping Trial vs. Immediate Removal
|
N/A | |
Enrolling by invitation |
NCT05878015 -
A Study of Intravenous Acetaminophen for Small Bowel Obstruction
|
Phase 4 | |
Recruiting |
NCT03139149 -
Comparison of Early Operative Treatment and 48 h Conservative Treatment in Small Bowel Obstruction
|
N/A | |
Active, not recruiting |
NCT06101719 -
Use of a Water Soluble Contrast-Based Protocol to Assist in the Management of Pediatric Adhesive Small Bowel Obstruction
|
||
Completed |
NCT00389116 -
Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
|
Phase 4 | |
Not yet recruiting |
NCT05843097 -
SnapSBO - Small Bowel Obstruction Snapshot Audit
|
||
Completed |
NCT05662384 -
Small Bowel Obstruction. A Prospective Multicener Study
|
||
Completed |
NCT04929275 -
Enhanced Recovery Programs and Small Bowel Obstruction
|
N/A | |
Not yet recruiting |
NCT06140173 -
Low-osmolar Water Soluble Contrast Agent in Management of Adhesive Small Bowel Obstruction
|
N/A | |
Completed |
NCT03461744 -
Diagnostic Scoring for Small Bowel Obstruction
|
||
Completed |
NCT02190981 -
Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department
|
||
Completed |
NCT01524081 -
Antibiotic Prophylaxis in the Prevention of Surgical Site Infections After Selected Urgent Abdominal Surgical Procedures
|
Phase 3 | |
Recruiting |
NCT06065150 -
Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
|
N/A | |
Completed |
NCT03386136 -
Therapeutic Oxygen for Gastrointestinal Atony (TOGA)
|
Phase 1 |