IntussusceptionNCT06748326
Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction After Failed Non-Surgical Therapies
A study testing Laparoscopy in people with Intussusception, run by Assiut University.
Trial summary
Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction after Failed Non-Surgical Therapies. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Intussusception
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2025to 1 Mar 2026
- Phase
- Interventional
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. childs aged 1 year to 12 years with intussusception who failed the hydrostatic reduction.
Who cannot join
- 1. Childs with Bad general conditions ( coagulopathy, haemodynamic instability, and severe cardiopulmonary diseases).
- 2. Known primary disease e.g. lymphoma and major congenital anomalies. 3. Previous abdominal surgeries.
About this study
Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction after Failed Non-Surgical Therapies.
Read the detailed description
Intussusception is one of the main abdominal emergencies in children. Its diagnosis is usually based on the clinical features and confirmed either by U/S and /or barium enema and CT scan in rare occasion. Since the introduction of the hydrostatic reduction of intussusceptions by Ravitch in 1848, it became the gold standard management. However surgical intervention is required if this and other non-operative approaches fail. This typically involves 10 to 20% of cases. Early on, the approach has been through an open laparotomy and manual reduction of intussusception. Later, the introduction of the laparoscopy in the paediatric surgical field has added another dimension to the management of intussusception. In addition to its confirmed general benefits of less pain, better cosmoses, and low long-term risk of adhesive bowel obstruction, it also can be a diagnostic modality in certain cases, primary reduce the intussusception and in some cases to resect the pathological lead point or the damaged segment of bowel. The laparoscope allowed the surgeons to avoid unnecessary open procedures in cases of spontaneous reduction following enema reductions, obviating the need for an open procedure in up to 30% of cases. Despite of all mentioned above, its effectiveness has been questioned.
- Conditions
- Intussusception
- Being tested
- Laparoscopy
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Intussusception reduction by laparoscopy in children in failed non surgical procedures and in recurrence
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic reduction of intussusception in children | Other | The abdomen is insufflated through an umbilical ring incision and a trocar is inserted to act as a camera Port. Two other ports for manipulation are placed depend on the position of the intussusception either in the right lower quadrant and the left upper quadrant or both the upper left and lower left quadrants of the abdomen. These ports position is assuming that radiological reduction has carried the intussusceptum to the right colon. Two atraumatic bowel clamps are used for bowel manipulation. The reduction is achieved by traction placed on the proximal bowel (intussusceptum) out of the distal segment (the intussuscepien). Receives: Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of Laparoscopy using in reduction of intussusception in children.
According to hospital stay, cosmesis and as a minimally invasive approach.
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 posted27 Dec 2024
- Study start3 May 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntussusceptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children with intussusception that failed non surgical procedures and whose with recurrence
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelrahman Ahmed Khalil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748326
- Sponsor's protocol ID
- Laparoscopy in Intussusception
- Status last verified
- Feb 2025
- First submitted
- 12 Nov 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction After Failed Non-Surgical Therapies
- ClinicalTrials.gov ID
- NCT06748326
- Acronym / sponsor ID
- Laparoscopy in Intussusception
- Conditions
- Intussusception
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 May 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Dec 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.
Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction after Failed Non-Surgical Therapies.
Detailed description
Intussusception is one of the main abdominal emergencies in children. Its diagnosis is usually based on the clinical features and confirmed either by U/S and /or barium enema and CT scan in rare occasion. Since the introduction of the hydrostatic reduction of intussusceptions by Ravitch in 1848, it became the gold standard management. However surgical intervention is required if this and other non-operative approaches fail. This typically involves 10 to 20% of cases. Early on, the approach has been through an open laparotomy and manual reduction of intussusception. Later, the introduction of the laparoscopy in the paediatric surgical field has added another dimension to the management of intussusception. In addition to its confirmed general benefits of less pain, better cosmoses, and low long-term risk of adhesive bowel obstruction, it also can be a diagnostic modality in certain cases, primary reduce the intussusception and in some cases to resect the pathological lead point or the damaged segment of bowel. The laparoscope allowed the surgeons to avoid unnecessary open procedures in cases of spontaneous reduction following enema reductions, obviating the need for an open procedure in up to 30% of cases. Despite of all mentioned above, its effectiveness has been questioned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children with intussusception that failed non surgical procedures and whose with recurrence
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic reduction of intussusception in children | Other | Procedure: LaparoscopyThe abdomen is insufflated through an umbilical ring incision and a trocar is inserted to act as a camera Port. Two other ports for manipulation are placed depend on the position of the intussusception either in the right lower quadrant and the left upper quadrant or both the upper left and lower left quadrants of the abdomen. These ports position is assuming that radiological reduction has carried the intussusceptum to the right colon. Two atraumatic bowel clamps are used for bowel manipulation. The reduction is achieved by traction placed on the proximal bowel (intussusceptum) out of the distal segment (the intussuscepien). |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. childs aged 1 year to 12 years with intussusception who failed the hydrostatic reduction.
Key exclusion criteria (2 listed)
- 1. Childs with Bad general conditions ( coagulopathy, haemodynamic instability, and severe cardiopulmonary diseases).
- 2. Known primary disease e.g. lymphoma and major congenital anomalies. 3. Previous abdominal surgeries.
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 |
|---|---|---|
| LaparoscopyIntussusception reduction by laparoscopy in children in failed non surgical procedures and in recurrence | Procedure or surgery | Laparoscopic reduction of intussusception in children |
Primary outcome
Results of Laparoscopy using in reduction of intussusception in children.
Time frame: 6 months
According to hospital stay, cosmesis and as a minimally invasive approach.
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 4 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy in people with Intussusception, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Results of Laparoscopy using in reduction of intussusception in children. (time frame: 6 months). 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 4 Feb 2025.