Inguinal Hernia, DirectNCT05092425
Analysis of Risk Factors for Children With Heterochronous Indirect Hernia
An observational study of Inguinal Hernia, Direct and Child, Only, run by Shanghai Children's Hospital.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Direct, Child, Only, Laparoscopic Surgery
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Inguinal Hernia, Direct, Child, Only, Laparoscopic Surgery
- Being tested
- no intervention
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| with CPPV | Group 1 is childrens with contralateral patent processus vaginalis. | |
| without CPPV | Group 2 is childrens without contralateral patent processus vaginalis. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of MCIH
the rate of MCIH developments after 24 months
Measured: 08.01.2021-07.31.2021
Secondary outcomes (1)
Complications
hernia recurrances, and postoperative complications such as wound infection, scrotal edema, haematoma, testicular atrophy, and iatrogenic cryptorchidism.
Measured: 08.01.2021-07.31.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia, DirectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Hebei Province, Shengjing Hospital, Children's Hospital of Nanjing Medical University, Anhui Provincial Children's Hospital, Tianjin Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Tongji Hospital, Zunyi Medical College, Henan Provincial Maternal and Child Health Care Hospital
- Responsible party
- Sponsor
- Investigators
- Zhibao Lv, PhD, Study chair, Shanghai Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092425
- Sponsor's protocol ID
- 2021R076
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23963735Dreuning 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.
PubMed 31317333Nakashima 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.
PubMed 31312986Kantor 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.
PubMed 31292721Shaughnessy 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.
PubMed 33549307Li 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.
PubMed 30255331Matsuda 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.
PubMed 29052338Zhu 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.
PubMed 28424930Zhao 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.
PubMed 27778329Ahmed 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.
PubMed 26421498Esposito 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.
PubMed 27521714
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors for Children With Heterochronous Indirect Hernia
- ClinicalTrials.gov ID
- NCT05092425
- Acronym / sponsor ID
- 2021R076
- Conditions
- Inguinal Hernia, Direct, Child, Only, Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Shanghai Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Hebei Province, Shengjing Hospital, Children's Hospital of Nanjing Medical University, Anhui Provincial Children's Hospital, Tianjin Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Tongji Hospital, Zunyi Medical College, Henan Provincial Maternal and Child Health Care Hospital
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with CPPV | – | –Group 1 is childrens with contralateral patent processus vaginalis. |
| without CPPV | – | Other: no interventionGroup 2 is childrens without contralateral patent processus vaginalis. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | without CPPV |
Primary outcome
The rate of MCIH
Time frame: 08.01.2021-07.31.2021
the rate of MCIH developments after 24 months
1 secondary outcome
Complications
Time frame: 08.01.2021-07.31.2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 23963735Kokorowski 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.
- Background: PubMed 31317333Dreuning 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.
- Background: PubMed 31312986Nakashima 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.
- Background: PubMed 31292721Kantor 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.
- Background: PubMed 33549307Shaughnessy 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.
- Background: PubMed 30255331Li 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.
- Background: PubMed 29052338Matsuda 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.
- Background: PubMed 28424930Zhu 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.
- Background: PubMed 27778329Zhao 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.
- Background: PubMed 26421498Ahmed 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.
- Background: PubMed 27521714Esposito 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhibao Lv, PhD study chair
Shanghai Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, Direct and Child, Only, run by Shanghai Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linlin Zhu, MD (+8615021751824, linlinz007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of MCIH (time frame: 08.01.2021-07.31.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05092425, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.