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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389116
First Posted: October 18, 2006
Last Update Posted: February 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Rouen
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Need for surgical management [ Time Frame: 2 months ]

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

Enrollment: 242
Study Start Date: November 2006
Study Completion Date: August 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: gastrograffin
ingestion
Placebo Comparator: 2 Drug: water
oral water ingestion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389116


Locations
France
CHU
Rouen, France, 76000
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scotté, Pr, CHU Rouen
ClinicalTrials.gov Identifier: NCT00389116     History of Changes
Other Study ID Numbers: 2005/069/HP
First Submitted: October 17, 2006
First Posted: October 18, 2006
Last Update Posted: February 25, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases