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

April 2, 2024 updated by: Nguyen Thanh Quang, National Children's Hospital, Vietnam

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

181

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • The National Hospital of Pediatrics
      • Hanoi, Vietnam
        • Vinmec Research Institute of Stem Cell and Gene Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intussusception
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
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.
Procedure: Transumbilical mini-open reduction
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: through study completion (5 years)
The average operating time (minutes) recorded between the two operating techniques (MOR or LAP)
through study completion (5 years)
Intraoperative complications
Time Frame: through study completion (5 years)
Instances of complications occurred during both operating techniques (MOR or LAP)
through study completion (5 years)
Immediate postoperative complications
Time Frame: through study completion (5 years)
Instances of complication occurred immediately subsequent to the operation utilizing either MOR or LAP
through study completion (5 years)
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)
through study completion (5 years)
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)
through study completion (5 years)
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)
through study completion (5 years)
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
through study completion (5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Children's Hospital, Vietnam

Collaborators

Vinmec Research Institute of Stem Cell and Gene Technology

Investigators

  • Principal Investigator: Quang T Nguyen, Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1451_03/BVNTW-VNCSKTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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