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Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

This study is currently recruiting participants.
Verified by University Hospital, Rouen, August 2008

Sponsored by: University Hospital, Rouen
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00389116
  Purpose

Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely frequent pathology, leading to a high rate of hospital admissions and money expense.

Management of small bowel obstruction is based on 2 options: either a surgical approach where all patients are operating on, or a conservative treatment in which surgery is proposed in case of failure of medical treatment. The surgical approach leads to operate on an excessive rate of patients while the medical approach increases the risk of increased small bowel resection, morbidity rate or hospitalization duration.

In order to improve the management of small bowel obstruction, it seems necessary to better distinguish patients that need an emergency surgical procedure from patients in which medical treatment will be useful. Many studies have been performed to investigate the value of imaging in the management of small bowel obstruction, using abdominal X-ray, oral gastrografin administration or CT-Scan.

The aim of this study is to analyse the effect of a systematic performance of imaging investigation on the management of patients presenting with a postoperative small bowel obstruction.

All patients suffering from a postoperative small bowel obstruction will be included in this study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral water administration while in group SG, Patients will have CT-Scan and oral gastrografin administration The major end point of this study is to analyse whether imaging examination can reduce the need for a surgical approach or the rate of small bowel resection and to determine its influence on fasting time or hospitalization duration


Condition Intervention Phase
Small Bowel Obstruction
Drug: gastrograffin
Drug: water
Phase IV

MedlinePlus related topics:   CT Scans    Drinking Water    Nuclear Scans   

ChemIDplus related topics:   Amidotrizoic Acid    Diatrizoate    Diatrizoate meglumine    Diatrizoate Sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment
Official Title:   Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Need for surgical management [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sensibility and specificity of gastrografin oral administration [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Sensibility and specificity of CT-Scan. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Sensibility and specificity of abdominal X-ray. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Fasting time [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Hospitalization time [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Number of small bowel resection [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   242
Study Start Date:   November 2006
Estimated Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: gastrograffin
ingestion
2: Placebo Comparator Drug: water
oral water ingestion

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Small bowel obstruction in patients with previous abdominal surgery

Exclusion Criteria:

  • Age less than 18 years
  • Early small bowel obstruction (less than 4 weeks following abdominal surgery)
  • Small bowel obstruction in the course of digestive cancer.
  • Hyperthermic small bowel obstruction
  • Small bowel ischemia (fever, peritoneal signs, increased leucocytosis)
  • Pregnancy ( Elevated béta HCG levels)
  • Inflammatory bowel disease
  • Previous abdominal radiotherapy
  • Pneumoperitoneum
  • Colorectal obstruction
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389116

Contacts
Contact: michel scotte, MD,PhD     33232888142     michel.scotte@chu-rouen.fr    

Locations
France
CHU     Recruiting
      ROUEN, France, 76000
      Principal Investigator: michel scotte            
      Principal Investigator: michel scotte, md, phd            

Sponsors and Collaborators
University Hospital, Rouen

Investigators
Principal Investigator:     michel scotté, MD,PhD     CHU Rouen    
Study Director:     francois mauvais, MD     chg Beauvais    
Study Director:     jean-marc regimbeau, MD, PhD     CHU amiens    
  More Information


Responsible Party:   CHU Rouen ( Scotté, Pr )
Study ID Numbers:   2005/069/HP
First Received:   October 17, 2006
Last Updated:   August 28, 2008
ClinicalTrials.gov Identifier:   NCT00389116
Health Authority:   France: Ministry of Health

Study placed in the following topic categories:
Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 19, 2008




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