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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:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00389116
First received: October 17, 2006
Last updated: February 24, 2011
Last verified: February 2011
  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 Blind (Subject)
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 ] [ 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University Hospital, Rouen

Additional 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
Study First Received: October 17, 2006
Last Updated: February 24, 2011
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014