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NCT Number: NCT06351163

Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study

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.

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Key information

Conditions

Intussusception Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The National Hospital of Pediatrics, Hanoi, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic reduction

Procedure

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.

Transumbilical mini-open reduction

Procedure

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.

Primary outcomes

  1. Operating time

    Time frame: through study completion (5 years)

    The average operating time (minutes) recorded between the two operating techniques (MOR or LAP)

  2. Intraoperative complications

    Time frame: through study completion (5 years)

    Instances of complications occurred during both operating techniques (MOR or LAP)

  3. Immediate postoperative complications

    Time frame: through study completion (5 years)

    Instances of complication occurred immediately subsequent to the operation utilizing either MOR or LAP

  4. Time to feed

    Time frame: through study completion (5 years)

    The average amount of time (days) for the patient to tolerate feeding post-operation (MOR or LAP)

  5. Hospital stays

    Time frame: through study completion (5 years)

    The average amount of time (days) for the patient to get discharged post-operation (MOR or LAP)

  6. Recurrence rate

    Time frame: through study completion (5 years)

    Instances when signs or symptoms of intussusception re-occurred after receiving treatment via operation (MOR or LAP)

  7. Long-term complication rate

    Time frame: through study completion (5 years)

    Instances of complications occurred post-operation found on subsequent follow-ups for patients treated with either MOR or LAP

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Collaborators

  • Vinmec Research Institute of Stem Cell and Gene Technology

Registry information

Official study title

Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study on the Long-Term Outcome

Important dates

Study start
2016
Primary completion
2020
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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