Completed

NCT Number: NCT00601809

(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).

Completed

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Key information

Conditions

Adhesive Small Intestine Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

S.Orsola-Malpighi University Hospital - University of Bologna, Bologna, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional conservative treatment (TT)

Other

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.

Gastrografin®: G

Drug

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

Primary outcomes

The operative rate in ASIO patients

Time frame: Within 72 hours and during hospital stay

Secondary outcomes

The incidence of major and minor complications of treatments in the two arm

Time frame: 1 year
The ASIO recurrences

Time frame: 1 year
The time to resolution of obstruction

Time frame: Within hospital stay
The length of hospital stay

Time frame: Within hospital admission period

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

Gastrografin Use in Small Bowel Obstruction Caused by Adherences

Acronym: GUSBOCA

Important dates

Study start: 2003
Study completion: 2006
First posted: Jan 28, 2008
Registry last updated: Jan 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.