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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05092425
Other study ID # 2021R076
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date July 31, 2024

Study information

Verified date October 2021
Source Shanghai Children's Hospital
Contact Linlin Zhu, MD
Phone +8615021751824
Email linlinz007@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 172
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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.)

Study Design


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
n/a

Sponsors (10)

Lead Sponsor Collaborator
Shanghai Children's Hospital Affiliated Hospital of Zunyi Medical University, Anhui Provincial Children's Hospital, Children's Hospital of Hebei Province, Children's Hospital of Nanjing Medical University, Maternal and Child Health Hospital of Henan Province, Shanxi Provincial Maternity and Children's Hospital, Shengjing Hospital, Tianjin Children's Hospital, Tongji Hospital

References & Publications (11)

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. — View Citation

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. — View Citation

Esposito C, Escolino M, Turrà 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Shaughnessy MP, Maassel NL, Yung N, Solomon DG, Cowles RA. Laparoscopy is increasingly used for pediatric inguinal hernia repair. J Pediatr Surg. 2021 Jan 27. pii: S0022-3468(21)00082-8. doi: 10.1016/j.jpedsurg.2021.01.032. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of MCIH the rate of MCIH developments after 24 months 08.01.2021-07.31.2021
Secondary Complications hernia recurrances, and postoperative complications such as wound infection, scrotal edema, haematoma, testicular atrophy, and iatrogenic cryptorchidism. 08.01.2021-07.31.2024
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