Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction

NCT00389116 | Completed Phase 4 DMC

• 1 other identifier: 2005/069/HP
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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

Conditions

Small Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

• Need for surgical management

  2 months

Secondary Outcomes (6)

• Sensibility and specificity of gastrografin oral administration

  2 months

• Sensibility and specificity of CT-Scan.

  2 months

• Sensibility and specificity of abdominal X-ray.

  2 months

• Fasting time

  2 months

• Hospitalization time

  2 months

Study Arms (2)

1

EXPERIMENTAL

Drug: gastrograffin

2

PLACEBO COMPARATOR

Drug: water

Interventions

gastrograffin DRUG

ingestion

1

water DRUG

oral water ingestion

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Small bowel obstruction in patients with previous abdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU

Rouen, 76000, France

Location

Related Publications (1)

• 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.

  PMID: 23522439 DERIVED

MeSH Terms

Interventions

Diatrizoate Meglumine; Water

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Diatrizoate; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hexosamines; Amino Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• michel scotté, MD,PhD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• francois mauvais, MD

  chg Beauvais

  STUDY DIRECTOR

• jean-marc regimbeau, MD, PhD

  CHU amiens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 18, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2010
• Last Updated: February 25, 2011

Record last verified: 2011-02

Locations

FR (1)