NCT06748326

Brief Summary

Laparoscopic Reduction of Intussusception in Children: Role in Primary Reduction after Failed Non-Surgical Therapies.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 3, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

November 12, 2023

Last Update Submit

February 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Results of Laparoscopy using in reduction of intussusception in children.

    According to hospital stay, cosmesis and as a minimally invasive approach.

    6 months

Study Arms (1)

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).

Procedure: Laparoscopy

Interventions

LaparoscopyPROCEDURE

Intussusception reduction by laparoscopy in children in failed non surgical procedures and in recurrence

Laparoscopic reduction of intussusception in children

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. childs aged 1 year to 12 years with intussusception who failed the hydrostatic reduction.

You may not qualify if:

  • \- 1. Childs with Bad general conditions ( coagulopathy, haemodynamic instability, and severe cardiopulmonary diseases).
  • \. Known primary disease e.g. lymphoma and major congenital anomalies. 3. Previous abdominal surgeries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intussusception

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Children with intussusception that failed non surgical procedures and whose with recurrence
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at surgical department at Assiut university

Study Record Dates

First Submitted

November 12, 2023

First Posted

December 27, 2024

Study Start

May 3, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

February 4, 2025

Record last verified: 2025-02