Clinical trial NCT05092425: Analysis of Risk Factors for Children With Heterochronous Indirect Hernia
Official title: Analysis of Risk Factors for Children With Heterochronous Indirect Hernia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia, Direct
Child, Only
Laparoscopic Surgery
Lead sponsor: Shanghai Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Hebei Province
name: Shengjing Hospital
name: Children's Hospital of Nanjing Medical University
name: Anhui Provincial Children's Hospital
name: Tianjin Children's Hospital
name: Shanxi Provincial Maternity and Children's Hospital
name: Tongji Hospital
name: Zunyi Medical College
name: Maternal and Child Health Hospital of Henan Province
First posted: 2021-10-25
Enrollment: 172
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Childrens dianosed as unilateral indirect inguinal hernia in Out-patient with a healthy history, non athelets. And parents preferred not to repair CPPV simultaneously in Laparoscopic indirect inguinal hernia repairing after informed all the benefits and risks

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: The rate of MCIH
timeFrame: 08.01.2021-07.31.2021
Secondary outcomes:
measure: Complications
timeFrame: 08.01.2021-07.31.2024
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Children's Hospital
name: Zhibao Lv, PhD
role: STUDY_CHAIR
References:
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