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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.
Study NCT00389116   Information provided by University Hospital, Rouen
First Received: October 17, 2006   Last Updated: February 17, 2009   History of Changes

October 17, 2006
February 17, 2009
November 2006
August 2009   (final data collection date for primary outcome measure)
Need for surgical management [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Need for surgical management
Complete list of historical versions of study NCT00389116 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Sensibility and specificity of gastrografin oral administration
  • Sensibility and specificity of CT-Scan.
  • Sensibility and specificity of abdominal X-ray.
  • Fasting time
  • Hospitalization time
  • Number of small bowel resection
 
Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

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

 
Phase IV
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment
Small Bowel Obstruction
  • Drug: gastrograffin
  • Drug: water
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
242
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: michel scotte, MD,PhD 33232888142 michel.scotte@chu-rouen.fr
France
 
NCT00389116
Scotté, Pr, CHU Rouen
2005/069/HP
University Hospital, Rouen
 
Principal Investigator: michel scotté, MD,PhD CHU Rouen
Study Director: francois mauvais, MD chg Beauvais
Study Director: jean-marc regimbeau, MD, PhD CHU Amiens
University Hospital, Rouen
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP