Adhesive Intestinal ObstructionNCT06870864
Conservative Versus Operative Management in Adhesive Intestinal Obstruction
An observational study of Adhesive Intestinal Obstruction, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the role of Conservative management in patients with adhesive Intestinal Obstruction Regarding the selection criteria of the patients, duration of conservative route, success rate, and recurrence of adhesions and avoiding the surgical route complications. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Adhesive Intestinal Obstruction
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Jan 2025
- 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 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with adhesive Intestinal Obstruction at Department of General Surgery, Oncological and Laparoscopic Surgeries, Sohag University Hospitals, Sohag, Egypt
Who may be able to join
- Age 6-70 years.
- Both sexes.
- Complete \ Partial adhesive Intestinal Obstruction, with CT Abdomen and pelvis with oral and IV Contrast.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Conservative Management in Adhesive Intestinal Obstruction Versus Operative Management
This study aims to evaluate the role of Conservative management in patients with adhesive Intestinal Obstruction Regarding the selection criteria of the patients, duration of conservative route, success rate, and recurrence of adhesions and avoiding the surgical route complications.
Read the 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.
- Conditions
- Adhesive Intestinal Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
X-Ray Changes
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).
Measured: 72 Hours
Passability Status
Daily history taking records and per rectal examination findings to evaluate the passability status (stool /flatus)
Measured: 72 Hours
Hospital Stay Duration
The Conservative management in patients with adhesive Intestinal Obstruction will avoid them the surgical route which requires long hospital stay postoperative
Measured: from 3 to 5 days.
Vomiting
Frequency and severity of vomiting will be collected to help in prognosis prediction
Measured: 72 Hours
Abdominal Signs
Data collected about Daily abdominal examination findings (Distention, Intestinal sounds, abdominal pain and Per rectal examination).
Measured: 72 Hours
Secondary outcomes (2)
Recurrence of Attacks
past history about the previous attacks of the adhesive Intestinal Obstruction
Measured: two years previous the onset of the current attack. (During the last two years before the admission)
Past Surgical History
Detailed history about the previous operations to determine the relationship between different operations and adhesive Intestinal Obstruction
Measured: two years previous the onset of the current attack. (During the last two years before the admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Khaled Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870864
- Sponsor's protocol ID
- Soh-Med--25-1-09MS
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Conservative Management in Adhesive Intestinal Obstruction Versus Operative Management
- ClinicalTrials.gov ID
- NCT06870864
- Acronym / sponsor ID
- Soh-Med--25-1-09MS
- Conditions
- Adhesive Intestinal Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Mar 2025 (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.
This study aims to evaluate the role of Conservative management in patients with adhesive Intestinal Obstruction Regarding the selection criteria of the patients, duration of conservative route, success rate, and recurrence of adhesions and avoiding the surgical route complications.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with adhesive Intestinal Obstruction at Department of General Surgery, Oncological and Laparoscopic Surgeries, Sohag University Hospitals, Sohag, Egypt
Key inclusion criteria (3 listed)
- Age 6-70 years.
- Both sexes.
- Complete \ Partial adhesive Intestinal Obstruction, with CT Abdomen and pelvis with oral and IV Contrast.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
X-Ray Changes
Time frame: 72 Hours
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).
Passability Status
Time frame: 72 Hours
Daily history taking records and per rectal examination findings to evaluate the passability status (stool /flatus)
Hospital Stay Duration
Time frame: from 3 to 5 days.
The Conservative management in patients with adhesive Intestinal Obstruction will avoid them the surgical route which requires long hospital stay postoperative
Vomiting
Time frame: 72 Hours
Frequency and severity of vomiting will be collected to help in prognosis prediction
Abdominal Signs
Time frame: 72 Hours
Data collected about Daily abdominal examination findings (Distention, Intestinal sounds, abdominal pain and Per rectal examination).
2 secondary outcomes
Recurrence of Attacks
Time frame: two years previous the onset of the current attack. (During the last two years before the admission)
Past Surgical History
Time frame: two years previous the onset of the current attack. (During the last two years before the admission)
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 11 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adhesive 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 3 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 11 Mar 2025. 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?
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?
X-Ray Changes (time frame: 72 Hours). The study lists 5 primary outcomes in all. 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 11 Mar 2025.