Intestinal ObstructionNCT05117645
Role of Computed Tomography in Evaluation of Different Causes of Intestinal Obstruction Correlated With Operative Findings
An observational study of Intestinal Obstruction, run by Sohag University at 1 site in Egypt.
Trial summary
Intestinal obstruction is a common clinical problem that occurs secondary to mechanical or functional obstruction of the intestine, preventing normal transit of its contents. It is a frequent cause of hospitalization and represents 15-20% of surgical admissions for acute abdominal pain . Read more about this study
- Who is it for?
- Ages 1 year and older, women only
- Conditions the study is for
- Intestinal Obstruction
- What is being tested?
- Computed tomography
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2021to Jun 2022
- Phase
- Observational
- 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 1 year and older
- Women only
- Child, Adult, Older adult
Study population: patients diagnosed that they have intestinal obstruction of any age group come to surgical emergency unit will be examined by general and local examination then they will be prepared by oral contrast according to their clinical condition , CT abdomen and pelvis will be done and then they will be explored to find out the cause and then results of CT and operative findings will be compared.
Who may be able to join
- Any age group and gender presented by manifestations of acute intestinal obstruction.
Who cannot join
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Mohamed Th Solyman, professor contact
About this study
Intestinal obstruction is a common clinical problem that occurs secondary to mechanical or functional obstruction of the intestine, preventing normal transit of its contents. It is a frequent cause of hospitalization and represents 15-20% of surgical admissions for acute abdominal pain .
The underlying aetiology of large bowel obstructions (LBOs) is age dependent, but in adulthood, the most common cause is colonic cancer (50-60%), typically in the sigmoid. The second most common cause in adults is acute diverticulitis (involving the sigmoid colon). Together, obstructing tumors and acute diverticulitis account for 90% of all causes of LBO.
Read more
Adhesions are the most common cause of small bowel obstruction (SBO) , For practical purposes, they do not tend to cause LBO.Other causes which cause symptoms that are mimic intestinal obstruction as in bowel ischemia that mainly caused by mesenteric vessels occlusion (adynamic obstruction).
Computed tomography (CT) has become a mainstay in diagnosing bowel obstruction. This is because the management of obstruction has dramatically changed with a decrease in the proportion of patients who need surgery Multi Detector Computed Tomography scanners provide a huge gain in performance that can be used to reduce the scan time, reduce section collimation, or to increase scan length surgery.
Diagnosis of intestinal obstruction is established by patient history and clinical findings include abdominal distension, acute abdominal pain, vomiting and inability to pass stools or flatus .
The role of CT in diagnosing intestinal obstruction has been expanding by determining presence, degree, level and cause (extrinsic lesions, intrinsic lesions, intussusception, intraluminal lesions) of obstruction and in identifying any associated strangulation, and also it has an important role in diagnosing the mesenteric vessels obstruction by thrombi by injection of IV contrast media which causes adynamic bowel obstruction .
- Conditions
- Intestinal Obstruction
- Being tested
- Computed tomography
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographyDiagnostic test
All patients will be examined by multislice CT scanner,Light speed 5X GE 8 detector elements scanner or GE Revolution Evo 128 multidetector elements scanner (GE Healthcare, Chicago, Illinois, United state) or Toshibe Alexion 16 detector elements scanner (Aplio 500, Toshiba Medical Systems, Otawara-shi, Tochigi 324-8550, Japan). Axial scanns will be done commences at 1 cm above the diaphragm and ending at lesser trochanters then coronal and sagittal reconstruction images will be exposed.
| Study group | Role | What they receive |
|---|---|---|
| Cases | patients come to surgical emergency unit and complaining of intestinal obstruction and CT Abdomen and pelvis will be done to detect the cause then will be compared with operative findings . Receives: Diagnostic Test: Computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emphasization the role of the MDCT in the evaluation of intestinal obstruction.
Patients complaining of intestinal obstruction will undergo oral preparation according to their condition then will undergo CT abdomen and pelvis , some of them will undergo exploration others will be observed then comparison with operative findings and observation will be done.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Nour Abdelghaffar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117645
- Sponsor's protocol ID
- soh-med-21-11-04
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
van Steensel S, van den Hil LCL, Schreinemacher MHF, Ten Broek RPG, van Goor H, Bouvy ND. Adhesion awareness in 2016: An update of the national survey of surgeons. PLoS One. 2018 Aug 17;13(8):e0202418. doi: 10.1371/journal.pone.0202418. eCollection 2018.
PubMed 30118503Jaffe T, Thompson WM. Large-Bowel Obstruction in the Adult: Classic Radiographic and CT Findings, Etiology, and Mimics. Radiology. 2015 Jun;275(3):651-63. doi: 10.1148/radiol.2015140916.
PubMed 25997131De Monti M, Cestaro G, Alkayyali S, Galafassi J, Fasolini F. Gallstone ileus: A possible cause of bowel obstruction in the elderly population. Int J Surg Case Rep. 2018;43:18-20. doi: 10.1016/j.ijscr.2018.01.010. Epub 2018 Feb 4.
PubMed 29414501
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Computed Tomography in Evaluation of Different Causes of Intestinal Obstruction Correlated With Operative Findings
- ClinicalTrials.gov ID
- NCT05117645
- Acronym / sponsor ID
- soh-med-21-11-04
- Conditions
- Intestinal Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 Nov 2021 (actual)
- 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.
Intestinal obstruction is a common clinical problem that occurs secondary to mechanical or functional obstruction of the intestine, preventing normal transit of its contents. It is a frequent cause of hospitalization and represents 15-20% of surgical admissions for acute abdominal pain .
The underlying aetiology of large bowel obstructions (LBOs) is age dependent, but in adulthood, the most common cause is colonic cancer (50-60%), typically in the sigmoid. The second most common cause in adults is acute diverticulitis (involving the sigmoid colon). Together, obstructing tumors and acute diverticulitis account for 90% of all causes of LBO.
Adhesions are the most common cause of small bowel obstruction (SBO) , For practical purposes, they do not tend to cause LBO.Other causes which cause symptoms that are mimic intestinal obstruction as in bowel ischemia that mainly caused by mesenteric vessels occlusion (adynamic obstruction).
Computed tomography (CT) has become a mainstay in diagnosing bowel obstruction. This is because the management of obstruction has dramatically changed with a decrease in the proportion of patients who need surgery Multi Detector Computed Tomography scanners provide a huge gain in performance that can be used to reduce the scan time, reduce section collimation, or to increase scan length surgery.
Diagnosis of intestinal obstruction is established by patient history and clinical findings include abdominal distension, acute abdominal pain, vomiting and inability to pass stools or flatus .
The role of CT in diagnosing intestinal obstruction has been expanding by determining presence, degree, level and cause (extrinsic lesions, intrinsic lesions, intussusception, intraluminal lesions) of obstruction and in identifying any associated strangulation, and also it has an important role in diagnosing the mesenteric vessels obstruction by thrombi by injection of IV contrast media which causes adynamic bowel obstruction .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Computed tomographypatients come to surgical emergency unit and complaining of intestinal obstruction and CT Abdomen and pelvis will be done to detect the cause then will be compared with operative findings . |
Who may qualify
- Ages
- 1 year and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed that they have intestinal obstruction of any age group come to surgical emergency unit will be examined by general and local examination then they will be prepared by oral contrast according to their clinical condition , CT abdomen and pelvis will be done and then they will be explored to find out the cause and then results of CT and operative findings will be compared.
Key inclusion criteria (1 listed)
- Any age group and gender presented by manifestations of acute intestinal obstruction.
Key exclusion criteria (1 listed)
- Pregnant women.
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 |
|---|---|---|
| Computed tomographyAll patients will be examined by multislice CT scanner,Light speed 5X GE 8 detector elements scanner or GE Revolution Evo 128 multidetector elements scanner (GE Healthcare, Chicago, Illinois, United state) or Toshibe Alexion 16 detector elements scanner (Aplio 500, Toshiba Medical Systems, Otawara-shi, Tochigi 324-8550, Japan). Axial scanns will be done commences at 1 cm above the diaphragm and ending at lesser trochanters then coronal and sagittal reconstruction images will be exposed. | Diagnostic test | Cases |
Primary outcome
Emphasization the role of the MDCT in the evaluation of intestinal obstruction.
Time frame: 6 months
Patients complaining of intestinal obstruction will undergo oral preparation according to their condition then will undergo CT abdomen and pelvis , some of them will undergo exploration others will be observed then comparison with operative findings and observation will be done.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background: PubMed 30118503van Steensel S, van den Hil LCL, Schreinemacher MHF, Ten Broek RPG, van Goor H, Bouvy ND. Adhesion awareness in 2016: An update of the national survey of surgeons. PLoS One. 2018 Aug 17;13(8):e0202418. doi: 10.1371/journal.pone.0202418. eCollection 2018.
- Background: PubMed 25997131Jaffe T, Thompson WM. Large-Bowel Obstruction in the Adult: Classic Radiographic and CT Findings, Etiology, and Mimics. Radiology. 2015 Jun;275(3):651-63. doi: 10.1148/radiol.2015140916.
- Background: PubMed 29414501De Monti M, Cestaro G, Alkayyali S, Galafassi J, Fasolini F. Gallstone ileus: A possible cause of bowel obstruction in the elderly population. Int J Surg Case Rep. 2018;43:18-20. doi: 10.1016/j.ijscr.2018.01.010. Epub 2018 Feb 4.
- Individual participant dataSharing planned: Yes
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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.
Mohamed Th Solyman, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Obstruction, run by Sohag 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 1 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa N Abd El ghafar, resident (01063550892, alaa011053@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emphasization the role of the MDCT in the evaluation of intestinal obstruction. (time frame: 6 months). 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 NCT05117645, which also lists 3 linked publications.
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 11 Nov 2021.