Analysis of Risk Factors for Children With Heterochronous Indirect Hernia

NCT05092425 | Unknown

• 1 other identifier: 2021R076
• Study Type: observational
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inguinal Hernia, Direct; Child, Only; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• The rate of MCIH

  the rate of MCIH developments after 24 months

  08.01.2021-07.31.2021

Secondary Outcomes (1)

• Complications

  08.01.2021-07.31.2024

Study Arms (2)

with CPPV

Group 1 is childrens with contralateral patent processus vaginalis.

without CPPV

Group 2 is childrens without contralateral patent processus vaginalis.

Other: no intervention

Interventions

no intervention OTHER

no intervention

without CPPV

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Shanghai Children's Hospital: lead
• Children's Hospital of Hebei Province: collaborator
• Shengjing Hospital: collaborator
• Children's Hospital of Nanjing Medical University: collaborator
• Anhui Provincial Children's Hospital: collaborator
• Tianjin Children's Hospital: collaborator
• Shanxi Provincial Maternity and Children's Hospital: collaborator
• Tongji Hospital: collaborator
• Zunyi Medical College: collaborator
• Maternal and Child Health Hospital of Henan Province: collaborator

Related Publications (11)

• Kokorowski PJ, Wang HH, Routh JC, Hubert KC, Nelson CP. Evaluation of the contralateral inguinal ring in clinically unilateral inguinal hernia: a systematic review and meta-analysis. Hernia. 2014 Jun;18(3):311-24. doi: 10.1007/s10029-013-1146-z. Epub 2013 Aug 21.

  PMID: 23963735 BACKGROUND

• Dreuning K, Maat S, Twisk J, van Heurn E, Derikx J. Laparoscopic versus open pediatric inguinal hernia repair: state-of-the-art comparison and future perspectives from a meta-analysis. Surg Endosc. 2019 Oct;33(10):3177-3191. doi: 10.1007/s00464-019-06960-2. Epub 2019 Jul 17.

  PMID: 31317333 BACKGROUND

• Nakashima M, Ide K, Kawakami K. Laparoscopic versus open repair for inguinal hernia in children: a retrospective cohort study. Surg Today. 2019 Dec;49(12):1044-1050. doi: 10.1007/s00595-019-01847-0. Epub 2019 Jul 16.

  PMID: 31312986 BACKGROUND

• Kantor N, Travis N, Wayne C, Nasr A. Laparoscopic versus open inguinal hernia repair in children: which is the true gold-standard? A systematic review and meta-analysis. Pediatr Surg Int. 2019 Sep;35(9):1013-1026. doi: 10.1007/s00383-019-04521-1. Epub 2019 Jul 10.

  PMID: 31292721 BACKGROUND

• Shaughnessy MP, Maassel NL, Yung N, Solomon DG, Cowles RA. Laparoscopy is increasingly used for pediatric inguinal hernia repair. J Pediatr Surg. 2021 Nov;56(11):2016-2021. doi: 10.1016/j.jpedsurg.2021.01.032. Epub 2021 Jan 27.

  PMID: 33549307 BACKGROUND

• Li Y, Wu Y, Wang C, Wang Q, Zhao Y, Ji Y, Xiang B. Incidence of pediatric metachronous contralateral inguinal hernia and the relationship with contralateral patent processus vaginalis. Surg Endosc. 2019 Apr;33(4):1087-1090. doi: 10.1007/s00464-018-6359-x. Epub 2018 Sep 25.

  PMID: 30255331 BACKGROUND

• Matsuda A, Miyashita M, Matsumoto S, Sakurazawa N, Kawano Y, Kuriyama S, Sekiguchi K, Ando F, Matsutani T, Uchida E. Laparoscopic transabdominal preperitoneal repair for strangulated inguinal hernia. Asian J Endosc Surg. 2018 May;11(2):155-159. doi: 10.1111/ases.12438. Epub 2017 Oct 19.

  PMID: 29052338 BACKGROUND

• Zhu LL, Xu WJ, Liu JB, Huang X, Lv ZB. Comparison of laparoscopic hernia repair and open herniotomy in children: a retrospective cohort study. Hernia. 2017 Jun;21(3):417-423. doi: 10.1007/s10029-017-1607-x. Epub 2017 Apr 19.

  PMID: 28424930 BACKGROUND

• Zhao J, Chen Y, Lin J, Jin Y, Yang H, Wang F, Zhong H, Zhu J. Potential value of routine contralateral patent processus vaginalis repair in children with unilateral inguinal hernia. Br J Surg. 2017 Jan;104(1):148-151. doi: 10.1002/bjs.10302. Epub 2016 Oct 25.

  PMID: 27778329 BACKGROUND

• Ahmed H, Youssef MK, Salem EA, Fawzi AM, Desoky EA, Eliwa AM, Sakr AM, Shahin AM. Efficacy of laparoscopically assisted high ligation of patent processus vaginalis in children. J Pediatr Urol. 2016 Feb;12(1):50.e1-5. doi: 10.1016/j.jpurol.2015.05.036. Epub 2015 Sep 15.

  PMID: 26421498 BACKGROUND

• Esposito C, Escolino M, Turra F, Roberti A, Cerulo M, Farina A, Caiazzo S, Cortese G, Servillo G, Settimi A. Current concepts in the management of inguinal hernia and hydrocele in pediatric patients in laparoscopic era. Semin Pediatr Surg. 2016 Aug;25(4):232-40. doi: 10.1053/j.sempedsurg.2016.05.006. Epub 2016 May 11.

  PMID: 27521714 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhibao Lv, PhD

  Shanghai Children's Hospital

  STUDY CHAIR

Central Study Contacts

Linlin Zhu, MD

CONTACT

+8615021751824; linlinz007@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: November 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share