Clinical trial NCT06351163: Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study
Official title: Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study on the Long-Term Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intussusception
Keywords: Intussusception
Minimally-invasive
Laparoscopic
Children
Pediatric
Air enema
Pneumatic reduction
Lead sponsor: National Children's Hospital, Vietnam
Sponsor class: OTHER
Collaborators: name: Vinmec Research Institute of Stem Cell and Gene Technology
First posted: 2024-04-08
Enrollment: 181
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2016 to December 2020, a group of pediatric patients displaying clinical manifestations suggestive of intussusception, coupled with positive ultrasound results, were admitted to the emergency department of the Vietnam National Children's Hospital. The patients underwent pneumatic reduction up to three attempts, with LAP being indicated if air enema reduction failed.

Brief summary: Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients.

Detailed description: Intussusception, the leading cause of intestinal obstruction in children aged 3 months to 5 years, significantly impacts morbidity and mortality rates. Most cases involve the ileocolic region and are typically amenable to resolution via air enema, achieving success rates of up to 95%. Surgical intervention becomes necessary in cases where pneumatic reduction fails or is contraindicated. Historically, the manual reduction required a substantial right-sided transverse incision. However, the advancement of minimally invasive approaches in pediatric surgery, particularly the laparoscopic approach (LAP), has gained traction in managing intussusception. LAP offers the advantages of decreased surgical trauma and shorter operative durations compared to open procedures. Nevertheless, the adoption of laparoscopic intervention for intussusception remains contentious due to challenges such as limited operative space in pediatric patients and variability in the affected bowel segment, impeding widespread acceptance. This study aims to investigate the safety and feasibility of laparoscopic (LAP) and mini-open reduction (MOR) techniques in managing idiopathic intussusception in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with idiopathic intussusception, admitted to the National Children's Hospital between January 2016 and December 2020, exhibiting clinical signs and symptoms consistent with intussusception, and confirmed by ultrasound.
* Fluoroscopy-guided pneumatic reduction was performed, allowing a maximum of three attempts.
* Patients unresponsive to pneumatic reduction underwent laparoscopic reduction (LAP).
* If LAP failed to manage the intussusceptum, conversion to transumbilical mini-open reduction (MOR) was initiated.
* Patients deemed unsuitable for air enema reduction due to a grossly distended abdomen or compromised cardiopulmonary function, making them unlikely to tolerate pneumoperitoneum, were also directed towards MOR.
* Patients with a history of previous intussusception episodes requiring reduction.
* Patients displaying clinical instability with signs of peritonitis or intestinal perforation requiring conventional laparotomy.
* Patients presenting with pathologic lead points.
* Patients who had complications, such as perforation, during pneumatic reduction.

Exclusion Criteria:

* Patients in critical condition or suspected of bowel perforation and peritonitis
* Patients who did not meet the criteria for air enema reduction due to significant abdominal distension or compromised cardiopulmonary function

Primary outcomes:
measure: Operating time
timeFrame: through study completion (5 years)
measure: Intraoperative complications
timeFrame: through study completion (5 years)
measure: Immediate postoperative complications
timeFrame: through study completion (5 years)
measure: Time to feed
timeFrame: through study completion (5 years)
measure: Hospital stays
timeFrame: through study completion (5 years)
measure: Recurrence rate
timeFrame: through study completion (5 years)
measure: Long-term complication rate
timeFrame: through study completion (5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: The National Hospital of Pediatrics
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
name: Quang T Nguyen
role: PRINCIPAL_INVESTIGATOR
References:
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