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

Primary Purpose

Adhesive Small Intestine Obstruction

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
traditional conservative treatment (TT)
Gastrografin®: G
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Small Intestine Obstruction focused on measuring Gastrointestinal, Adhesive Small Intestine Obstruction, Oral water soluble contrast, Non-operative Conservative Management, Operative rate, Hospital stay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

GG

TT

Arm Description

Outcomes

Primary Outcome Measures

The operative rate in ASIO patients

Secondary Outcome Measures

The incidence of major and minor complications of treatments in the two arm
The ASIO recurrences
The time to resolution of obstruction
The length of hospital stay

Full Information

First Posted
January 14, 2008
Last Updated
January 25, 2008
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT00601809
Brief Title
(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)
Acronym
GUSBOCA
Official Title
Gastrografin Use in Small Bowel Obstruction Caused by Adherences
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Small Intestine Obstruction
Keywords
Gastrointestinal, Adhesive Small Intestine Obstruction, Oral water soluble contrast, Non-operative Conservative Management, Operative rate, Hospital stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GG
Arm Type
Experimental
Arm Title
TT
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
traditional conservative treatment (TT)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gastrografin®: G
Other Intervention Name(s)
water-soluble contrast medium (Gastrografin®: G) meal
Intervention Description
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.
Primary Outcome Measure Information:
Title
The operative rate in ASIO patients
Time Frame
Within 72 hours and during hospital stay
Secondary Outcome Measure Information:
Title
The incidence of major and minor complications of treatments in the two arm
Time Frame
1 year
Title
The ASIO recurrences
Time Frame
1 year
Title
The time to resolution of obstruction
Time Frame
Within hospital stay
Title
The length of hospital stay
Time Frame
Within hospital admission period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fausto Catena, MD, PhD
Organizational Affiliation
S.Orsola-Malpighi University Hospital - University of Bologna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luca Ansaloni, MD
Organizational Affiliation
S.Orsola-Malpighi University Hospital - University of Bologna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margherita Gavioli, MD
Organizational Affiliation
University of Modena
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salomone Di Saverio, M.D.
Organizational Affiliation
S.Orsola-Malpighi University Hospital - University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.Orsola-Malpighi University Hospital - University of Bologna
City
Bologna
Country
Italy
Facility Name
Emergency Surgery Department - University of Modena
City
Modena
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18688562
Citation
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.
Results Reference
derived

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(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

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