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

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

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.

Study Overview

• Status: Completed
• Conditions: Small Bowel Obstruction
• Intervention / Treatment: Drug: Somatostatin; Other: common daily practice

Detailed Description

1. 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. 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：

4. 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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing PLAGH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somatostatin+common daily practice	Drug: Somatostatin; 250ug/h,Continuous I.V. infusion,maximal 14 days; Other Names: Stilamin
Placebo Comparator: common daily practice	Other: common daily practice; common daily practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete recovery rate of EPSSBO = (Num. of patients with complete recovery of EPSSBO per group/Total num. of patients per group) * 100	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Average recovery time	14 days
Re-surgery rate	14 days
Average NG (naso-gastric) aspirate volume	14 days
Average re-dehydration volume	14 days
Change of blood electrolytes	14 days
Degree of symptom and sign relief	14 days

Collaborators and Investigators

• Sponsor: Nanjing PLA General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: March 5, 2010
• First Submitted That Met QC Criteria: March 5, 2010
• First Posted (Estimate): March 8, 2010

Study Record Updates

• Last Update Posted (Estimate): August 3, 2011
• Last Update Submitted That Met QC Criteria: August 2, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Somatostatin small bowel obstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Somatostatin
• Other Study ID Numbers: Nanjing Jinling Hospital