Small Bowel ObstructionNCT00738855
Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO)
A study testing Oral Gastrografin and Nothing per os in people with Small Bowel Obstruction, run by Mansoura University at 1 site in Egypt.
Trial summary
Mini abstract : Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group showed a significant decrease of both the time between admission and operation and that of hospital stay .The need for surgery was… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- Oral Gastrografin and Nothing per os
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2006to Jan 2008
- Phase
- Interventional
- 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
- Patients admitted to our surgical department by postoperative SBO were considered for inclusion in this trial.
Who cannot join
- Age less than 18 years
- Large bowel obstruction
- Recent (within 4 weeks) abdominal surgery
- Ileus
- Cancer peritonitis
- Peritonitis
Show all 10Show fewer
- Strangulation symptoms and signs
- Obstructed abdominal wall or groin hernia
- Subtotal or total colectomy
- All patients in whom the final diagnosis was not SBO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO).
Mini abstract :
Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group showed a significant decrease of both the time between admission and operation and that of hospital stay .The need for surgery was reduced but statistically insignificant.
Read the detailed description
Abstract
Background:
Many published studies have shown that Gastrografin can be used for diagnosis post operative acute small bowel obstruction (ASBO) and assessing the need for surgical intervention .However,the studies have reported conflicting results hence the aim of our study to test this hypothesis.
Patients and methods :
Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups in a double blinded fashion. Eight episodes in eight patients were excluded due to protocol violation. In Gastrografin group,100 ml of the dye administered through a nasogastric tube and complete obstruction has been considered if the contrast failed to reach the colon on the 24-hour film. Patients were operated on only if they developed signs of strangulation or failed to improve within 48 hours.
- Conditions
- Small Bowel Obstruction
- Being tested
- Oral Gastrografin, Nothing per os
- Keywords
- Adhesions, Oral contrast, Exploration
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral GastrografinOther
Also called oral contrast
100 ml of the dye administered through a nasogastric tube
Nothing per osOther
Also called no oral contrast
A nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gastrografin group Receives: Other: Oral Gastrografin |
| 2 | Placebo comparator | Control group Receives: Other: Nothing per os |
What is being measured
The primary outcome is the main question the study is designed to answer.
resolving
Measured: 48 hours
Secondary outcomes (1)
non resolving
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startFeb 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- amir fikry, MD, Principal investigator, Mansoura University Hospitalayman mohamed, MD, Study director, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738855
- Sponsor's protocol ID
- oral gastrografin
- Other IDs
- oral, gastrografin, follow through, in, adhesive SBO.
- Status last verified
- Aug 2008
- First submitted
- 19 Aug 2008
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO).
- ClinicalTrials.gov ID
- NCT00738855
- Acronym / sponsor ID
- oral gastrografin
- Conditions
- Small Bowel Obstruction
- Keywords
- Adhesions, Oral contrast, Exploration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Aug 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.
Mini abstract :
Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group showed a significant decrease of both the time between admission and operation and that of hospital stay .The need for surgery was reduced but statistically insignificant.
Detailed description
Abstract
Background:
Many published studies have shown that Gastrografin can be used for diagnosis post operative acute small bowel obstruction (ASBO) and assessing the need for surgical intervention .However,the studies have reported conflicting results hence the aim of our study to test this hypothesis.
Patients and methods :
Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups in a double blinded fashion. Eight episodes in eight patients were excluded due to protocol violation. In Gastrografin group,100 ml of the dye administered through a nasogastric tube and complete obstruction has been considered if the contrast failed to reach the colon on the 24-hour film. Patients were operated on only if they developed signs of strangulation or failed to improve within 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Oral GastrografinGastrografin group |
| 2 | Placebo comparator | Other: Nothing per osControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to our surgical department by postoperative SBO were considered for inclusion in this trial.
Key exclusion criteria (10 listed)
- Age less than 18 years
- Large bowel obstruction
- Recent (within 4 weeks) abdominal surgery
- Ileus
- Cancer peritonitis
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 |
|---|---|---|
| Oral GastrografinAlso: oral contrast100 ml of the dye administered through a nasogastric tube | Other | 1 |
| Nothing per osAlso: no oral contrastA nasogastric tube | Other | 2 |
Primary outcome
resolving
Time frame: 48 hours
1 secondary outcome
non resolving
Time frame: 48 hours
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 26 Nov 2008.
Related trials for Small Bowel Obstruction
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Management of Non Emergency Adhesive Small Bowel Obstruction:
SBO - Small Bowel Obstruction
RecruitingObservational study
Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD)
Recruiting
The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial
Small Bowel Obstruction, Intestinal Obstruction and Ileus
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.
amir fikry, MD principal investigator
Mansoura University Hospital
ayman mohamed, MD study director
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Gastrografin and Nothing per os in people with Small Bowel Obstruction, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 10 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 26 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
resolving (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2008.