Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
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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 |
- Need for surgical management [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- 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 |
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| France | |
| CHU | |
| Rouen, France, 76000 | |
| 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
| 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 Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013