Inguinal Hernia,Laparoscopy,Extra-peritonealNCT02960529
A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children
An observational study of Inguinal Hernia,Laparoscopy,Extra-peritoneal, run by zebing Zheng at 1 site in China.
Trial summary
Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. Read more about this study
- Who is it for?
- Ages 6 months to 13 years, men only
- Conditions the study is for
- Inguinal Hernia,Laparoscopy,Extra-peritoneal
- What is being tested?
- extra-peritoneal high ligation of hernia and intraabdominal high ligation of hernia
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2017
- 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 6 months to 13 years
- Men only
- No healthy volunteers
- Child
Study population: All patients between 6 months and 13 years undergoing trans-umbilical single-port laparoscopic approach repair for inguinal hernia at our institution. half of patients undergoing extra-peritoneal andthe others undergoing intraabdominal.
Who may be able to join
- unilateral inguinal herina age between 6 months and 13 years no history of abdominal or inguinal operations of male patients ,only those with completely descended testes were included
Who cannot join
- the bilateral heina the recurrence herina
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of ZunYi medical college
Zunyi, Guizhou, 563000
Fan Zhang, PHD
About this study
Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. The conventional approach this is done with2small trocars to 1trocar . however the wound complications of infection and pain and the recurrent rate have not been resolved. The aim of the study was to described a new way of extra-peritoneal high ligation of hernia sac. This method combines the single-port laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia repair in children. The investigators hoped that this study will prove that the extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as the conventional technique in the cure of inguinal hernia and may results in lower recurrence and reduce incidence of wound complications.
- Being tested
- extra-peritoneal high ligation of hernia, intraabdominal high ligation of hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra-peritoneal high ligation of herniaProcedure or surgery
intraabdominal high ligation of herniaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| extra-peritoneal high ligation of hernia | the 150 patients were subjected trans-umbilical single-port laparoscopic extra-peritoneal approach repair for inguinal hernia Receives: Procedure: extra-peritoneal high ligation of hernia | |
| intraabdominal high ligation of hernia | the 150 patients were subjected trans-umbilical single-port laparoscopic intraabdominal approach repair for inguinal hernia Receives: Procedure: intraabdominal high ligation of hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion to intraabdominal high ligation of inguinal hernia
this study is to determine whether extra-peritoneal single-port laparoscopic repair for inguinal hernia in children is superior to conventional repair approaches.
Measured: during operation
Secondary outcomes (5)
operating time
this assess the time taken to perform the operation and is defined as time from initial skin to complete wound closure
Measured: during operation
length of hospital time
this assess how long patient stays in hospital
Measured: day procedure or overnight stay
post operative pain scores
this utlizes the CHEOPS pain score4-7,day 1 and day 7 after surgy
Measured: preop, day one and day 7 postop
recurrence of inguinal herina
patients will be assessed at 1 week,6 week and one year to detect presence of recurrence of inguinal herina
Measured: 1 year
post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy.
patients will be seen at 1 week,6 week to assess for any peri-operative complications associated with inguinal herina surgery as enumerated above.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia,Laparoscopy,Extra-peritonealStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- zebing Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, zebing Zheng, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960529
- Sponsor's protocol ID
- ZunyiMC
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jun Z, Juntao G, Shuli L, Li L. A comparative study on trans-umbilical single-port laparoscopic approach versus conventional repair for incarcerated inguinal hernia in children. J Minim Access Surg. 2016 Apr-Jun;12(2):139-42. doi: 10.4103/0972-9941.169953.
PubMed 27073306Wolak PK, Patkowski D. Laparoscopic inguinal hernia repair in children using the percutaneous internal ring suturing technique - own experience. Wideochir Inne Tech Maloinwazyjne. 2014 Mar;9(1):53-8. doi: 10.5114/wiitm.2014.40389. Epub 2014 Jan 30.
PubMed 24729810Blanco FC, Kane TD. Single-port laparoscopic surgery in children: concept and controversies of the new technique. Minim Invasive Surg. 2012;2012:232347. doi: 10.1155/2012/232347. Epub 2012 Jun 12.
PubMed 22778945Lukong CS. Surgical techniques of laparoscopic inguinal hernia repair in childhood: a critical appraisal. J Surg Tech Case Rep. 2012 Jan;4(1):1-5. doi: 10.4103/2006-8808.100343.
PubMed 23066453
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children
- ClinicalTrials.gov ID
- NCT02960529
- Acronym / sponsor ID
- ZunyiMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- zebing ZhengUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- 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.
Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. The conventional approach this is done with2small trocars to 1trocar . however the wound complications of infection and pain and the recurrent rate have not been resolved. The aim of the study was to described a new way of extra-peritoneal high ligation of hernia sac. This method combines the single-port laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia repair in children. The investigators hoped that this study will prove that the extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as the conventional technique in the cure of inguinal hernia and may results in lower recurrence and reduce incidence of wound complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extra-peritoneal high ligation of hernia | – | Procedure: extra-peritoneal high ligation of herniathe 150 patients were subjected trans-umbilical single-port laparoscopic extra-peritoneal approach repair for inguinal hernia |
| intraabdominal high ligation of hernia | – | Procedure: intraabdominal high ligation of herniathe 150 patients were subjected trans-umbilical single-port laparoscopic intraabdominal approach repair for inguinal hernia |
Who may qualify
- Ages
- 6 months to 13 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients between 6 months and 13 years undergoing trans-umbilical single-port laparoscopic approach repair for inguinal hernia at our institution. half of patients undergoing extra-peritoneal andthe others undergoing intraabdominal.
Key inclusion criteria (1 listed)
- unilateral inguinal herina age between 6 months and 13 years no history of abdominal or inguinal operations of male patients ,only those with completely descended testes were included
Key exclusion criteria (1 listed)
- the bilateral heina the recurrence herina
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 |
|---|---|---|
| extra-peritoneal high ligation of hernia | Procedure or surgery | extra-peritoneal high ligation of hernia |
| intraabdominal high ligation of hernia | Procedure or surgery | intraabdominal high ligation of hernia |
Primary outcome
conversion to intraabdominal high ligation of inguinal hernia
Time frame: during operation
this study is to determine whether extra-peritoneal single-port laparoscopic repair for inguinal hernia in children is superior to conventional repair approaches.
5 secondary outcomes
operating time
Time frame: during operation
length of hospital time
Time frame: day procedure or overnight stay
post operative pain scores
Time frame: preop, day one and day 7 postop
recurrence of inguinal herina
Time frame: 1 year
post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy.
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Background: PubMed 27073306Jun Z, Juntao G, Shuli L, Li L. A comparative study on trans-umbilical single-port laparoscopic approach versus conventional repair for incarcerated inguinal hernia in children. J Minim Access Surg. 2016 Apr-Jun;12(2):139-42. doi: 10.4103/0972-9941.169953.
- Background: PubMed 24729810Wolak PK, Patkowski D. Laparoscopic inguinal hernia repair in children using the percutaneous internal ring suturing technique - own experience. Wideochir Inne Tech Maloinwazyjne. 2014 Mar;9(1):53-8. doi: 10.5114/wiitm.2014.40389. Epub 2014 Jan 30.
- Background: PubMed 22778945Blanco FC, Kane TD. Single-port laparoscopic surgery in children: concept and controversies of the new technique. Minim Invasive Surg. 2012;2012:232347. doi: 10.1155/2012/232347. Epub 2012 Jun 12.
- Background: PubMed 23066453Lukong CS. Surgical techniques of laparoscopic inguinal hernia repair in childhood: a critical appraisal. J Surg Tech Case Rep. 2012 Jan;4(1):1-5. doi: 10.4103/2006-8808.100343.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia,Laparoscopy,Extra-peritoneal, run by zebing Zheng at 1 site in China.
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 1 inclusion and 1 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zebing Zheng, MD (8618285269257, 674013289@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conversion to intraabdominal high ligation of inguinal hernia (time frame: during operation). 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 NCT02960529, which also lists 4 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 9 Nov 2016.