(Gastrografin Use in Small Bowel Obstruction Caused by Adherences) (GUSBOCA)

Gastrografin Use in Small Bowel Obstruction Caused by Adherences

Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a very common disease. Any improvement in this field will benefit many patients by reducing the operative rate. Patients with this disease are difficult to evaluate and to manage and their treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or in the case of total obstruction. On the other hand, conservative non-operative treatment is indicated in the case of partial obstruction. The role of water-soluble contrast medium (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value.

The aim of our study was to determine the therapeutic role of Gastrografin in patients with small intestine obstruction without strangulation caused by adherences (ASIO).

Study Overview

• Status: Completed
• Conditions: Adhesive Small Intestine Obstruction
• Intervention / Treatment: Drug: Gastrografin®: G; Other: traditional conservative treatment (TT)

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • S.Orsola-Malpighi University Hospital - University of Bologna
  • Modena, Italy
    • Emergency Surgery Department - University of Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (>18 years)
• History of previous abdominal surgical procedures
• Clinical and radiological evidence of adhesive small intestine obstruction without signs of strangulation and peritonism
• ASA I-III patients
• Informed consent

Exclusion Criteria:

• Suspicion of strangulation
• Actual presence or high suspicion of intra-abdominal malignancy
• Suspicion or history of peritoneal carcinomatosis
• active inflammatory bowel disease
• Positive history of radiotherapy on the abdominal region
• Obstructed hernias

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GG	Drug: Gastrografin®: G; The study group (GG: Gastrografin Group) received, beyond the traditional conservative treatment for ASIO above mentioned, a G meal with a follow-through study immediately.; Other Names: water-soluble contrast medium (Gastrografin®: G) meal
Other: TT	Other: traditional conservative treatment (TT); In the control group (TT: Traditional Treatment), the patients have been treated as in our daily surgical practice of traditional conservative treatment for ASIO, consisting in nil per os diet, nasogastric tube (NGT) decompression and intravenous fluid resuscitation therapy with electrolytes imbalances correction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The operative rate in ASIO patients	Within 72 hours and during hospital stay

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of major and minor complications of treatments in the two arm	1 year
The ASIO recurrences	1 year
The time to resolution of obstruction	Within hospital stay
The length of hospital stay	Within hospital admission period

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Fausto Catena, MD, PhD, S.Orsola-Malpighi University Hospital - University of Bologna; Principal Investigator: Luca Ansaloni, MD, S.Orsola-Malpighi University Hospital - University of Bologna; Principal Investigator: Margherita Gavioli, MD, University of Modena; Principal Investigator: Salomone Di Saverio, M.D., S.Orsola-Malpighi University Hospital - University of Bologna

Publications and helpful links

General Publications

• Di Saverio S, Catena F, Ansaloni L, Gavioli M, Valentino M, Pinna AD. Water-soluble contrast medium (gastrografin) value in adhesive small intestine obstruction (ASIO): a prospective, randomized, controlled, clinical trial. World J Surg. 2008 Oct;32(10):2293-304. doi: 10.1007/s00268-008-9694-6.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Estimate): January 28, 2008
• Last Update Submitted That Met QC Criteria: January 25, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Gastrointestinal; Hospital stay; Adhesive Small Intestine Obstruction; Oral water soluble contrast; Non-operative Conservative Management; Operative rate
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: GUSBOCA