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

This study has been completed.
Sponsor:
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
  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:

  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.


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:
  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.
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01082627

Locations
China, Jiangsu
Nanjing PLAGH
Nanjing, Jiangsu, China
Sponsors and Collaborators
Nanjing PLA General Hospital
  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 October 01, 2014