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NCT Number: NCT00389116

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gastrograffin

Drug

ingestion

Water

Drug

oral water ingestion

Primary outcomes

  1. Need for surgical management

    Time frame: 2 months

Secondary outcomes

  1. Sensibility and specificity of gastrografin oral administration

    Time frame: 2 months

  2. Sensibility and specificity of CT-Scan.

    Time frame: 2 months

  3. Sensibility and specificity of abdominal X-ray.

    Time frame: 2 months

  4. Fasting time

    Time frame: 2 months

  5. Hospitalization time

    Time frame: 2 months

  6. Number of small bowel resection

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Oct 18, 2006
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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