Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction After Failed Non-Surgical Therapies
February 2, 2025 updated by: Mahmoud Abdelrahman Ahmed Khalil, Assiut University
Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction after Failed Non-Surgical Therapies.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. childs aged 1 year to 12 years with intussusception who failed the hydrostatic reduction.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Laparoscopic reduction of intussusception in children
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).
|
Intussusception reduction by laparoscopy in children in failed non surgical procedures and in recurrence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 3, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
November 12, 2023
First Submitted That Met QC Criteria
December 23, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 2, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laparoscopy in Intussusception
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.