Intussusception Clinical Trial
Official title:
Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study on the Long-Term Outcome
Verified date | April 2024 |
Source | National Children's Hospital, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 181 |
Est. completion date | March 2024 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | The National Hospital of Pediatrics | Hanoi | |
Vietnam | Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi |
Lead Sponsor | Collaborator |
---|---|
National Children's Hospital, Vietnam | Vinmec Research Institute of Stem Cell and Gene Technology |
Vietnam,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operating time | The average operating time (minutes) recorded between the two operating techniques (MOR or LAP) | through study completion (5 years) | |
Primary | Intraoperative complications | Instances of complications occurred during both operating techniques (MOR or LAP) | through study completion (5 years) | |
Primary | Immediate postoperative complications | Instances of complication occurred immediately subsequent to the operation utilizing either MOR or LAP | through study completion (5 years) | |
Primary | Time to feed | The average amount of time (days) for the patient to tolerate feeding post-operation (MOR or LAP) | through study completion (5 years) | |
Primary | Hospital stays | The average amount of time (days) for the patient to get discharged post-operation (MOR or LAP) | through study completion (5 years) | |
Primary | Recurrence rate | Instances when signs or symptoms of intussusception re-occurred after receiving treatment via operation (MOR or LAP) | through study completion (5 years) | |
Primary | Long-term complication rate | Instances of complications occurred post-operation found on subsequent follow-ups for patients treated with either MOR or LAP | through study completion (5 years) |
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