Hernia, InguinalNCT02310958
Outcome of Laparoscopic Inguinal Herniorraphy in Children
An observational study of Hernia, Inguinal, run by Johannes Mayr.
Trial summary
The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will be based on a review of hospital records and a questionnaire answered by families. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Laparoscopic surgical hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to 26 May 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 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged between 1 day and 16 years who underwent laparoscopic surgical inguinal hernia repair between March 2010 and March 2014 at a single institution.
Who may be able to join
- Children aged between 1 day and 16 years who underwent a laparoscopic surgical procedure for correction of unilateral or bilateral inguinal hernia or recurrent inguinal hernia at a single institution
Who cannot join
- age of patient more than 16 years
- patients suffering from neuromuscular, chronic abdominal, chronic pulmonary, or malignant disorders
- patients suffering from degenerative soft tissue disorders
- patients receiving immunosuppressive drugs for more than 3 weeks or during a - 3-week perioperative time interval
About this study
Official title: A Single Center, Retrospective Study of the Outcome of Laparoscopic Inguinal Herniorraphy in Children
The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will be based on a review of hospital records and a questionnaire answered by families. Patient demographics (age, gender), affected side, type and duration of laparoscopic intervention, and outcome parameters (hernia recurrence, post-operative complications, eg. infections, length and type of postoperative pain medication, and length of the postoperative hospital stay) will be analysed.
Read the detailed description
Hernias of the abdominal wall occur if intra-abdominal tissue or peritoneum bulges through the abdominal wall. The most frequent locations of abdominal wall hernia are the inguinal region close to the groin, the umbilicus, and scars. Congenital inguinal hernias occur more frequently in the inguinal region if the vaginal process is not closed adequately at birth. Surgical procedures for correction of inguinal hernias are frequently carried out in children. Laparoscopic procedures to correct inguinal hernias in children are gaining more acceptance. The laparoscopic closure of hernias in children is considered effective and safe and represents an accepted alternative to the open surgical hernia repair. When compared to open surgical hernia repair in children, laparoscopic hernia repair causes smaller scars, allows for a faster postoperative recovery of children, requires less pain medication, and allows for an inspection of the contralateral side, thus facilitating simultaneous hernia repair in the same operation.
We aim to investigate the short-term results of laparoscopic inguinal hernia repair in children. The main outcome parameter of this single-center study is hernia recurrence or the occurrence of contralateral metachronous hernia. Secondary outcome measures are postoperative complications such as infections of the wound regions, the time between operation and discharge from hospital, and postoperative pain medication requirements. We chose a 4-year time interval for inclusion of patients. Data are retrieved from hospital records in a retrospective evaluation. In addition, a structured questionnaire sent to the families of children will document postoperative complaints and complications from 3 months after the operation onwards. Families not responding to the questionnaire will be offered a structured telephone interview.
- Conditions
- Hernia, Inguinal
- Being tested
- Laparoscopic surgical hernia repair
- Keywords
- Lapraroscopic surgical procedure, infant, complications, inguinal hernia, hernia recurrence
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgical hernia repairProcedure or surgery
Laparoscopic surgical hernia repair in children
| Study group | Role | What they receive |
|---|---|---|
| Children with inguinal hernia | Laparoscopic surgical hernia repair in children aged between 1 day and 16 years Receives: Procedure: Laparoscopic surgical hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inguinal hernia recurrence
Measured: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
Secondary outcomes (4)
postoperative complications (infections)
Measured: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
length of hospital stay
Measured: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
type of pain medication and duration of use after surgical procedure
Measured: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
metachronous hernia occurrence
Occurrence of contralateral hernia after operation of unilateral hernia
Measured: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Mayr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johannes Mayr, University Children's Hospital Basel
- Investigators
- Sucharitha Geiger, Study chair, University Childrens Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310958
- Sponsor's protocol ID
- EKNZ2014-247
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2014
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
American College of Surgeons. Surgical Patient Education. http://www.facs.org/patient education.
Kapur P, Caty MG, Glick PL. Pediatric hernias and hydroceles. Pediatr Clin North Am. 1998 Aug;45(4):773-89. doi: 10.1016/s0031-3955(05)70044-4.
PubMed 9728185Kiesewetter WB, Oh KS. Unilateral inguinal hernias in children: What about the opposite side? Arch Surg. 1980 Dec;115(12):1443-5. doi: 10.1001/archsurg.1980.01380120019005.
PubMed 7447688Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, Miller J, Lucas GW, Promes J. Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg. 1999 Sep;65(9):827-31; discussion 831-2.
PubMed 10484084Tsai YC, Wu CC, Yang SS. Minilaparoscopic herniorrhaphy with hernia sac transection in children and young adults: a preliminary report. Surg Endosc. 2007 Sep;21(9):1623-5. doi: 10.1007/s00464-007-9207-y. Epub 2007 Mar 13.
PubMed 17353989Tsai YC, Wu CC, Yang SS. Is local anesthesia or oral analgesics necessary after mini-laparoscopic functional surgery in children and young adults?: A prospective randomized trial. Surg Laparosc Endosc Percutan Tech. 2008 Aug;18(4):344-7. doi: 10.1097/SLE.0b013e318172ab33.
PubMed 18716531
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Retrospective Study of the Outcome of Laparoscopic Inguinal Herniorraphy in Children
- ClinicalTrials.gov ID
- NCT02310958
- Acronym / sponsor ID
- EKNZ2014-247
- Conditions
- Hernia, Inguinal
- Keywords
- Lapraroscopic surgical procedure, infant, complications, inguinal hernia, hernia recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Johannes MayrUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 8 Dec 2014 (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.
The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will be based on a review of hospital records and a questionnaire answered by families. Patient demographics (age, gender), affected side, type and duration of laparoscopic intervention, and outcome parameters (hernia recurrence, post-operative complications, eg. infections, length and type of postoperative pain medication, and length of the postoperative hospital stay) will be analysed.
Detailed description
Hernias of the abdominal wall occur if intra-abdominal tissue or peritoneum bulges through the abdominal wall. The most frequent locations of abdominal wall hernia are the inguinal region close to the groin, the umbilicus, and scars. Congenital inguinal hernias occur more frequently in the inguinal region if the vaginal process is not closed adequately at birth. Surgical procedures for correction of inguinal hernias are frequently carried out in children. Laparoscopic procedures to correct inguinal hernias in children are gaining more acceptance. The laparoscopic closure of hernias in children is considered effective and safe and represents an accepted alternative to the open surgical hernia repair. When compared to open surgical hernia repair in children, laparoscopic hernia repair causes smaller scars, allows for a faster postoperative recovery of children, requires less pain medication, and allows for an inspection of the contralateral side, thus facilitating simultaneous hernia repair in the same operation.
We aim to investigate the short-term results of laparoscopic inguinal hernia repair in children. The main outcome parameter of this single-center study is hernia recurrence or the occurrence of contralateral metachronous hernia. Secondary outcome measures are postoperative complications such as infections of the wound regions, the time between operation and discharge from hospital, and postoperative pain medication requirements. We chose a 4-year time interval for inclusion of patients. Data are retrieved from hospital records in a retrospective evaluation. In addition, a structured questionnaire sent to the families of children will document postoperative complaints and complications from 3 months after the operation onwards. Families not responding to the questionnaire will be offered a structured telephone interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with inguinal hernia | – | Procedure: Laparoscopic surgical hernia repairLaparoscopic surgical hernia repair in children aged between 1 day and 16 years |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged between 1 day and 16 years who underwent laparoscopic surgical inguinal hernia repair between March 2010 and March 2014 at a single institution.
Key inclusion criteria (1 listed)
- Children aged between 1 day and 16 years who underwent a laparoscopic surgical procedure for correction of unilateral or bilateral inguinal hernia or recurrent inguinal hernia at a single institution
Key exclusion criteria (4 listed)
- age of patient more than 16 years
- patients suffering from neuromuscular, chronic abdominal, chronic pulmonary, or malignant disorders
- patients suffering from degenerative soft tissue disorders
- patients receiving immunosuppressive drugs for more than 3 weeks or during a - 3-week perioperative time interval
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 |
|---|---|---|
| Laparoscopic surgical hernia repairLaparoscopic surgical hernia repair in children | Procedure or surgery | Children with inguinal hernia |
Primary outcome
Inguinal hernia recurrence
Time frame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
4 secondary outcomes
postoperative complications (infections)
Time frame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
length of hospital stay
Time frame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
type of pain medication and duration of use after surgical procedure
Time frame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
metachronous hernia occurrence
Time frame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- BackgroundAmerican College of Surgeons. Surgical Patient Education. http://www.facs.org/patient education.
- Background: PubMed 9728185Kapur P, Caty MG, Glick PL. Pediatric hernias and hydroceles. Pediatr Clin North Am. 1998 Aug;45(4):773-89. doi: 10.1016/s0031-3955(05)70044-4.
- Background: PubMed 7447688Kiesewetter WB, Oh KS. Unilateral inguinal hernias in children: What about the opposite side? Arch Surg. 1980 Dec;115(12):1443-5. doi: 10.1001/archsurg.1980.01380120019005.
- Background: PubMed 10484084Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, Miller J, Lucas GW, Promes J. Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg. 1999 Sep;65(9):827-31; discussion 831-2.
- Background: PubMed 17353989Tsai YC, Wu CC, Yang SS. Minilaparoscopic herniorrhaphy with hernia sac transection in children and young adults: a preliminary report. Surg Endosc. 2007 Sep;21(9):1623-5. doi: 10.1007/s00464-007-9207-y. Epub 2007 Mar 13.
- Background: PubMed 18716531Tsai YC, Wu CC, Yang SS. Is local anesthesia or oral analgesics necessary after mini-laparoscopic functional surgery in children and young adults?: A prospective randomized trial. Surg Laparosc Endosc Percutan Tech. 2008 Aug;18(4):344-7. doi: 10.1097/SLE.0b013e318172ab33.
- Individual participant dataSharing planned: No
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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.
Sucharitha Geiger study chair
University Childrens Hospital Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal, run by Johannes Mayr.
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 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: finished, as of the sponsor's last update on 3 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inguinal hernia recurrence (time frame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months). 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 NCT02310958, which also lists 6 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 3 Dec 2020.