Adhesions BowelNCT06446440
Lap Adhesiolysis in Intestinal Obstruction
An observational study of Adhesions Bowel, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison between the results of laparotomy and laparoscopy in adhesive intestinal obstruction and introduce the use of laparoscopy to the emergency setting in Asyut University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesions Bowel
- What is being tested?
- Laparoscopic adhesiolysis and Open adhesiolysis
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Any case of intestinal obstruction and failed medical treatment and for surgery either open or laparoscopic adhesiolysis
Who may be able to join
- any male or female above 18 years has adhesive Intestinal obstruction
- patient fulfilled the criteria to participate but operated before time of study if adequate data available
- patient in which conservative management is failed
Who cannot join
- othe casues of intestinal obstruction (other than adhsions)
- shocked patient
- cardiovascular diseases
- coagulopathy
- liver cirrhosis
- intracranial diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut
Assiut University Hospitals, +2088241-1906, irbasyut@aun.edu.eg
About this study
Official title: Comperative Study Between Laparoscopic Adhesiolysis Vs Open Adhesiolysis in Adhesive Intestinal Obstruction
Comparison between the results of laparotomy and laparoscopy in adhesive intestinal obstruction and introduce the use of laparoscopy to the emergency setting in Asyut University Hospital.
Read the detailed description
Adhesive Intestinal obstruction is one of the most common complications after any abdominal surgery.
Adhesions account for 75% of causes of intestinal obstruction. laparoscopic adhesiolysis recently increase in frequency over open adhesiolysis but there is no definit evidence of its superiority. In term of length of hospital stay and morbidity.
adhesive bowel obstruction mainly managed by conservative treatment but some refractory cases needs surgical intervention In this study we will evaluate feasibility and efficacy of using laparoscop in adhesiolysis over open approach .
- Conditions
- Adhesions Bowel
- Being tested
- Laparoscopic adhesiolysis, Open adhesiolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adhesiolysisProcedure or surgery
Laparoscopic adhesiolysis
Open adhesiolysisProcedure or surgery
Open adhesiolysis
| Study group | Role | What they receive |
|---|---|---|
| Group A | These group will include cases underwent laparoscopic adhesiolysis Receives: Procedure: Laparoscopic adhesiolysis | |
| Group B | These group will include cases underwent open adhesiolysis Receives: Procedure: Open adhesiolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Signs and symptoms of intestinal obstruction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Dec 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesions BowelStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bemen Soliman Haroun Abdulla, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446440
- Sponsor's protocol ID
- Lap adhesiolysis
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comperative Study Between Laparoscopic Adhesiolysis Vs Open Adhesiolysis in Adhesive Intestinal Obstruction
- ClinicalTrials.gov ID
- NCT06446440
- Acronym / sponsor ID
- Lap adhesiolysis
- Conditions
- Adhesions Bowel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2024 (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.
Comparison between the results of laparotomy and laparoscopy in adhesive intestinal obstruction and introduce the use of laparoscopy to the emergency setting in Asyut University Hospital.
Detailed description
Adhesive Intestinal obstruction is one of the most common complications after any abdominal surgery.
Adhesions account for 75% of causes of intestinal obstruction. laparoscopic adhesiolysis recently increase in frequency over open adhesiolysis but there is no definit evidence of its superiority. In term of length of hospital stay and morbidity.
adhesive bowel obstruction mainly managed by conservative treatment but some refractory cases needs surgical intervention In this study we will evaluate feasibility and efficacy of using laparoscop in adhesiolysis over open approach .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Laparoscopic adhesiolysisThese group will include cases underwent laparoscopic adhesiolysis |
| Group B | – | Procedure: Open adhesiolysisThese group will include cases underwent open adhesiolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any case of intestinal obstruction and failed medical treatment and for surgery either open or laparoscopic adhesiolysis
Key inclusion criteria (3 listed)
- any male or female above 18 years has adhesive Intestinal obstruction
- patient fulfilled the criteria to participate but operated before time of study if adequate data available
- patient in which conservative management is failed
Key exclusion criteria (6 listed)
- othe casues of intestinal obstruction (other than adhsions)
- shocked patient
- cardiovascular diseases
- coagulopathy
- liver cirrhosis
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 |
|---|---|---|
| Laparoscopic adhesiolysisLaparoscopic adhesiolysis | Procedure or surgery | Group A |
| Open adhesiolysisOpen adhesiolysis | Procedure or surgery | Group B |
Primary outcome
Recurrence rate
Time frame: 2 years
Signs and symptoms of intestinal obstruction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Adhesions Bowel, run by Assiut 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: looking for participants now, as of the sponsor's last update on 6 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 2 years). 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 6 Jun 2024.