An observational study in Intussusception, sponsored by National Children's Hospital, Vietnam. Completed at 2 sites in Vietnam. Open to participants aged 2 Months to 12 Years. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by National Children's Hospital, Vietnam · 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.
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.
31 studies on the registry are indexed under Intussusception; 6 are open to participants now.
This study's enrollment of 181 is below the median of 250 across 15 observational studies indexed under Intussusception.
Browse Intussusception studies →National Children's Hospital, Vietnam is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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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.
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Exclusion Criteria:
Pediatric patients exhibiting clinical signs and symptoms of intussusception between January 2016 and December 2020 that fit in with the inclusion criteria of the study.
Procedure: Laparoscopic reduction · Procedure: Transumbilical mini-open reduction
A 1cm longitudinal transumbilical incision was made to insert a 5mm trocar for laparoscope placement. CO2 was injected at 10mmHg and a flow rate of 3L. Two 5-mm working trocars were inserted in the lower right and left abdomen under direct visualization, along with two grasping forceps. The ascending colon was manipulated to locate the intussusception mass. Atraumatic graspers were alternately utilized on the ascending colon to mobilize the intussusceptum, pushing it downward towards the cecum. The first visible part of the terminal ileum was grasped and pulled outward and downward, along with its mesentery, using the right grasper, while the left grasper pulled the intussusceptum's neck in the opposite direction. If resistance was encountered, the terminal ileum could be held with the left hand while the right grasper widened the intussusceptum's neck. After reduction, the intestines were examined for necrosis and possible lead points, followed by routine appendectomy and ileopexy.
If laparoscopic reduction alone was unsuccessful or if bowel resection was required, the intussusceptum was fixed with grasping forceps and brought to the umbilicus for MOR. A 2cm transumbilical incision was created, and a skin retractor was inserted. The underlying fascia was longitudinally extended upward and downward along the linea alba. Upon division of the peritoneum, the actual opening could be expanded up to 5cm, while maintaining the skin incision at 2cm. If the initial incision site proved insufficient for exploration, lateral division of the rectus muscle around the umbilicus on both sides could be performed without cutting the skin, thereby enlarging the surgical field. Manual reduction of the intussusceptum was subsequently carried out, along with bowel resection and anastomosis as indicated.
Operating time
The average operating time (minutes) recorded between the two operating techniques (MOR or LAP)
Time frame: through study completion (5 years)
Intraoperative complications
Instances of complications occurred during both operating techniques (MOR or LAP)
Time frame: through study completion (5 years)
Immediate postoperative complications
Instances of complication occurred immediately subsequent to the operation utilizing either MOR or LAP
Time frame: through study completion (5 years)
Time to feed
The average amount of time (days) for the patient to tolerate feeding post-operation (MOR or LAP)
Time frame: through study completion (5 years)
Hospital stays
The average amount of time (days) for the patient to get discharged post-operation (MOR or LAP)
Time frame: through study completion (5 years)
Recurrence rate
Instances when signs or symptoms of intussusception re-occurred after receiving treatment via operation (MOR or LAP)
Time frame: through study completion (5 years)
Long-term complication rate
Instances of complications occurred post-operation found on subsequent follow-ups for patients treated with either MOR or LAP
Time frame: through study completion (5 years)
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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National Children's Hospital, Vietnam