Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
Primary Purpose
Small Bowel Obstruction
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
gastrograffin
water
Sponsored by
About this trial
This is an interventional treatment trial for Small Bowel Obstruction
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
Sites / Locations
- CHU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Need for surgical management
Secondary Outcome Measures
Sensibility and specificity of gastrografin oral administration
Sensibility and specificity of CT-Scan.
Sensibility and specificity of abdominal X-ray.
Fasting time
Hospitalization time
Number of small bowel resection
Full Information
NCT ID
NCT00389116
First Posted
October 17, 2006
Last Updated
February 24, 2011
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00389116
Brief Title
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
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
gastrograffin
Intervention Description
ingestion
Intervention Type
Drug
Intervention Name(s)
water
Intervention Description
oral water ingestion
Primary Outcome Measure Information:
Title
Need for surgical management
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Sensibility and specificity of gastrografin oral administration
Time Frame
2 months
Title
Sensibility and specificity of CT-Scan.
Time Frame
2 months
Title
Sensibility and specificity of abdominal X-ray.
Time Frame
2 months
Title
Fasting time
Time Frame
2 months
Title
Hospitalization time
Time Frame
2 months
Title
Number of small bowel resection
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
michel scotté, MD,PhD
Organizational Affiliation
CHU Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
francois mauvais, MD
Organizational Affiliation
chg Beauvais
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
jean-marc regimbeau, MD, PhD
Organizational Affiliation
CHU amiens
Official's Role
Study Director
Facility Information:
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23522439
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.
Results Reference
derived
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Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
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