- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870864
Conservative Versus Operative Management in Adhesive Intestinal Obstruction
Role of Conservative Management in Adhesive Intestinal Obstruction Versus Operative Management
Study Overview
Status
Conditions
Detailed Description
Adhesive Intestinal Obstruction is very common and represents a serious life threatening condition, which can be caused by congenital band, following abdominal surgeries and other medical conditions like tuberculosis.
The management options for adhesive intestinal obstruction (AIO) could be operative treatment (open-laparoscopy) or non-operative (conservative management) according to many reasons.
Some reports indicate that the operative management for adhesive Intestinal obstruction lead to further adhesions in the future in addition to other possible complications (anaesthetic - iatrogenic injury during adhesolysis - wound site infections - illius-long hospital stay).
The Conservative route is recommended in all patients except those with signs of peritonitis, strangulation, or bowel ischemia which would have been diagnosed during physical examination and imaging.
A few studies compared the advantages, safety, and less complications of Conservative versus operative management. Therefore, this study will be conducted on patients with adhesive Intestinal Obstruction to compare the effectiveness of Conservative versus operative management regarding the selection criteria for the patients, the duration of the Conservative route, things to be done and what need to be observed during the conversation time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sohag, Egypt
- Faculty of Medicine, Sohag University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 6-70 years.
- Both sexes.
- Complete \ Partial adhesive Intestinal Obstruction, with CT Abdomen and pelvis with oral and IV Contrast.
Exclusion Criteria:
- Patients with signs of Strangulation
- Patients with signs of peritonitis.
- Patients with signs of bowel ischemia
- Failure of Conservative management for more than 72 hours.
- Vitally unstable patients
- Patients with comorbidities which need rapid interventions.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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X-Ray Changes
Time Frame: 72 Hours
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Daily Chest Abdomen X-ray Erect copies to evaluate the improvement of the Intestinal Obstruction through evaluation of the X-ray findings (Air fluid levels).
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72 Hours
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Passability Status
Time Frame: 72 Hours
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Daily history taking records and per rectal examination findings to evaluate the passability status (stool /flatus)
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72 Hours
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Hospital Stay Duration
Time Frame: from 3 to 5 days.
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The Conservative management in patients with adhesive Intestinal Obstruction will avoid them the surgical route which requires long hospital stay postoperative
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from 3 to 5 days.
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Vomiting
Time Frame: 72 Hours
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Frequency and severity of vomiting will be collected to help in prognosis prediction
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72 Hours
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Abdominal Signs
Time Frame: 72 Hours
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Data collected about Daily abdominal examination findings (Distention, Intestinal sounds, abdominal pain and Per rectal examination).
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72 Hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recurrence of Attacks
Time Frame: two years previous the onset of the current attack. (During the last two years before the admission)
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past history about the previous attacks of the adhesive Intestinal Obstruction
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two years previous the onset of the current attack. (During the last two years before the admission)
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Past Surgical History
Time Frame: two years previous the onset of the current attack. (During the last two years before the admission)
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Detailed history about the previous operations to determine the relationship between different operations and adhesive Intestinal Obstruction
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two years previous the onset of the current attack. (During the last two years before the admission)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med--25-1-09MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adhesive Intestinal Obstruction
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Uppsala UniversityCompletedAdhesive Small Bowel Obstruction
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Uppsala UniversityCompletedAdhesive Small Bowel Obstruction
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University of BolognaCompletedAdhesive Small Intestine ObstructionItaly
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