Clinical trial NCT00389116: Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
Official title: Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Small Bowel Obstruction
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2006-10-18
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Need for surgical management
timeFrame: 2 months
Secondary outcomes:
measure: Sensibility and specificity of gastrografin oral administration
timeFrame: 2 months
measure: Sensibility and specificity of CT-Scan.
timeFrame: 2 months
measure: Sensibility and specificity of abdominal X-ray.
timeFrame: 2 months
measure: Fasting time
timeFrame: 2 months
measure: Hospitalization time
timeFrame: 2 months
measure: Number of small bowel resection
timeFrame: 2 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU
Study officials:
affiliation: CHU Rouen
name: michel scotté, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: chg Beauvais
name: francois mauvais, MD
role: STUDY_DIRECTOR
affiliation: CHU amiens
name: jean-marc regimbeau, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Cosse C, Regimbeau JM, Fuks D, Mauvais F, Scotte M. Serum procalcitonin for predicting the failure of conservative management and the need for bowel resection in patients with small bowel obstruction. J Am Coll Surg. 2013 May;216(5):997-1004. doi: 10.1016/j.jamcollsurg.2012.12.051. Epub 2013 Mar 19.