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Analysis of Risk Factors for Children With Heterochronous Indirect Hernia

Analysis of Risk Factors for Children With Heterochronous Indirect Hernia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05092425
Enrollment
172
Registered
2021-10-25
Start date
2021-11-01
Completion date
2024-07-31
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Only, Inguinal Hernia, Direct, Laparoscopic Surgery

Brief summary

Laparoscopic contralateral patent processus vaginalis (CPPV) repair in infancy and childhood is still debatable, due to the high CPPV rate but low contralateral metachronous hernia (MCIH) rate. In order to found risk factors for MH, we conducted this prospective study. This is an multi-center investigator-initiated observational prospective trial. After informed all the benefits and risks of repair CPPV simultaneously, those patients with unilateral inguinal hernia whose parents preferred not to repair CPPV simultaneously will be assigned in the study. All information about demographic data, hernia side, CPPV type and CPPV diameter will be recorded. The subjects will be followed up until MCIH developing or to 24 months postoperatively. Patients will be analyzed to identify the risk factors for MH.

Detailed description

Inguinal hernia (IH) is one of the most common diseases in pediatric surgery with an overall rate of 0.8-4.4%1, and 75-90% of these patients were with unilateral inguinal hernia (UIH). Children with UIH have a chance of subsequently developing metachronous contralateral inguinal hernia (MCIH). Whether to explore the contralateral side in children with UIH has been debated for many decades. Surgeons used to practiced contralateral exploration in children due to the high reported incidence of a contralateral patent processus vaginalis (CPPV) and the increased risk of general anesthesia at the very young. Then surgeons noted that only few CPPV might develop into a clinical hernia, and routine exploration puts both testicles and both vas deferens at risk. Because of this fact, many surgeons have abandoned routine contralateral exploration. As laparoscopic hernia repair is performed in children, CPPV exploration and ligation become much easier, without extra incision. A lot of literature reported that CPPV ligation could prevent MCIH and regarded this as a major benefit of laparoscopic hernia repair. Still, the laparoscopic CPPV rates (28%-66%) are much higher than the rates of MCIH developing (2.4% to 13.9%). Therefore one would need to perform 4 to 21 operations to prevent one future hernia. Whether to close the CPPV simultaneously in children with UIH is still controversial. We think that either yes or no is not the best answer. It is essential to identify the risk factors of MCIH to make the best strategies to balance the risks and benefits. We, therefore, designed a prospective observational study of pediatric patients with UIH to detect the risk factors of MCIH. This is an multi-center investigator-initiated observational prospective trial. After informed all the benefits and risks of repair CPPV simultaneously, those patients with unilateral inguinal hernia whose parents preferred not to repair CPPV simultaneously will be assigned in the study. Patients included in this trial will receive laparoscopically extraperitoneal high ligation of the hernia sac and detection of the contralateral side. All information about demographic data, hernia side, CPPV type and CPPV diameter will be recorded. The subjects will be followed up until MCIH developing or to 24 months postoperatively. Patients will be analyzed to identify the risk factors for MH.

Interventions

OTHERno intervention

no intervention

Sponsors

Children's Hospital of Hebei Province
CollaboratorOTHER
Shengjing Hospital
CollaboratorOTHER
Children's Hospital of Nanjing Medical University
CollaboratorOTHER
Anhui Provincial Children's Hospital
CollaboratorOTHER
Tianjin Children's Hospital
CollaboratorOTHER
Shanxi Provincial Maternity and Children's Hospital
CollaboratorOTHER
Tongji Hospital
CollaboratorOTHER
Zunyi Medical College
CollaboratorOTHER
Maternal and Child Health Hospital of Henan Province
CollaboratorUNKNOWN
Shanghai Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Unilateral indirect inguinal hernia in males and females (0-18 years old) * Healthy (based on history), non-athletes * The guardian understands the purpose and risks of the study and signs the relevant informed consent

Exclusion criteria

* Recurrent indirect inguinal hernia * Incarcerated indirect inguinal hernia * The ultrasonography shows contralateral patent processus vaginalis * with other systemic diseases (such as chronic constipation, chronic cough, cardiopulmonary insufficiency, liver and kidney insufficiency, abdominal wall malformation, urinary tract malformation, etc.)

Design outcomes

Primary

MeasureTime frameDescription
The rate of MCIH08.01.2021-07.31.2021the rate of MCIH developments after 24 months

Secondary

MeasureTime frameDescription
Complications08.01.2021-07.31.2024hernia recurrances, and postoperative complications such as wound infection, scrotal edema, haematoma, testicular atrophy, and iatrogenic cryptorchidism.

Contacts

Primary ContactLinlin Zhu, MD
linlinz007@163.com+8615021751824

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026