Adhesive Small Intestine ObstructionPhase 4GUSBOCANCT00601809
(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)
A Phase 4 study testing traditional conservative treatment (TT) and Gastrografin®: G in people with Adhesive Small Intestine Obstruction, run by University of Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Small Intestine Obstruction
- What is being tested?
- traditional conservative treatment (TT) and Gastrografin®: G
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2003to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
S.Orsola-Malpighi University Hospital - University of Bologna
Bologna
Emergency Surgery Department - University of Modena
Modena
About this study
Official title: 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).
- Conditions
- Adhesive Small Intestine Obstruction
- Being tested
- traditional conservative treatment (TT), Gastrografin®: G
- Keywords
- Gastrointestinal, Adhesive Small Intestine Obstruction, Oral water soluble contrast, Non-operative Conservative Management, Operative rate, Hospital stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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®: GDrug
Also called water-soluble contrast medium (Gastrografin®: G) meal
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.
| Study group | Role | What they receive |
|---|---|---|
| GG | Experimental | Not described Receives: Drug: Gastrografin®: G |
| TT | Other | Not described Receives: Other: traditional conservative treatment (TT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The operative rate in ASIO patients
Measured: Within 72 hours and during hospital stay
Secondary outcomes (4)
The incidence of major and minor complications of treatments in the two arm
Measured: 1 year
The ASIO recurrences
Measured: 1 year
The time to resolution of obstruction
Measured: Within hospital stay
The length of hospital stay
Measured: Within hospital admission period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startSep 2003
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adhesive Small Intestine ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Fausto Catena, MD, PhD, Principal investigator, S.Orsola-Malpighi University Hospital - University of BolognaLuca Ansaloni, MD, Principal investigator, S.Orsola-Malpighi University Hospital - University of BolognaMargherita Gavioli, MD, Principal investigator, University of Modena and Reggio EmiliaSalomone Di Saverio, M.D., Principal investigator, S.Orsola-Malpighi University Hospital - University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601809
- Sponsor's protocol ID
- GUSBOCA
- Acronym
- GUSBOCA
- Status last verified
- Jan 2008
- First submitted
- 14 Jan 2008
- Last updated
- 28 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18688562
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrografin Use in Small Bowel Obstruction Caused by Adherences
- ClinicalTrials.gov ID
- NCT00601809
- Acronym / sponsor ID
- GUSBOCA / GUSBOCA
- Conditions
- Adhesive Small Intestine Obstruction
- Keywords
- Gastrointestinal, Adhesive Small Intestine Obstruction, Oral water soluble contrast, Non-operative Conservative Management, Operative rate, Hospital stay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Nov 2006 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GG | Experimental | Drug: Gastrografin®: G |
| TT | Other | Other: traditional conservative treatment (TT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | TT |
| Gastrografin®: GAlso: water-soluble contrast medium (Gastrografin®: G) mealThe study group (GG: Gastrografin Group) received, beyond the traditional conservative treatment for ASIO above mentioned, a G meal with a follow-through study immediately. | Drug | GG |
Primary outcome
The operative rate in ASIO patients
Time frame: Within 72 hours and during hospital stay
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2008.
- Derived from this study: PubMed 18688562Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fausto Catena, MD, PhD principal investigator
S.Orsola-Malpighi University Hospital - University of Bologna
Luca Ansaloni, MD principal investigator
S.Orsola-Malpighi University Hospital - University of Bologna
Margherita Gavioli, MD principal investigator
University of Modena and Reggio Emilia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing traditional conservative treatment (TT) and Gastrografin®: G in people with Adhesive Small Intestine Obstruction, run by University of Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The operative rate in ASIO patients (time frame: Within 72 hours and during hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2008.