- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02310958
Outcome of Laparoscopic Inguinal Herniorraphy in Children
A Single Center, Retrospective Study of the Outcome of Laparoscopic Inguinal Herniorraphy in Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with inguinal hernia
Laparoscopic surgical hernia repair in children aged between 1 day and 16 years
|
Laparoscopic surgical hernia repair in children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
Occurrence of contralateral hernia after operation of unilateral hernia
|
Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sucharitha Geiger, University Childrens Hospital Basel
Publications and helpful links
General 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.
- Kiesewetter 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.
- Ramshaw 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.
- Tsai 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.
- Tsai 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ2014-247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hernia, Inguinal
-
Children's Mercy Hospital Kansas CityRecruitingInguinal Hernia | Inguinal Hernia, Indirect | Inguinal Hernia Unilateral | Inguinal Hernia BilateralUnited States
-
Hospital General Universitario ElcheCompletedInguinal Hernia | Inguinal Hernia Repair | Open Inguinal Hernia
-
San Bonifacio HospitalCompletedIndirect Inguinal Hernia | Direct Inguinal HerniaItaly
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalEnrolling by invitationInguinal Hernia | Strangulated Inguinal Hernia | Incarcerated Inguinal HerniaTurkey
-
University Hospital, GhentMedriCompleted
-
Ahmadullah DanishCompletedIncarcerated Inguinal HerniaAfghanistan
-
General Hospital of LarissaUnknown
-
Alexandria UniversityCompletedBilateral Inguinal Hernia
-
Hospital Siberia-SerenaUnknownPrimary Inguinal HerniaSpain
-
Diskapi Teaching and Research HospitalCompleted
Clinical Trials on Laparoscopic surgical hernia repair
-
The Cleveland ClinicIntuitive SurgicalCompleted
-
Second Hospital of Jilin UniversityCompletedInguinal HerniaChina
-
The Cleveland ClinicCompleted
-
University Hospital, GenevaUnknownPain | Laparoscopic Surgery | Inguinal Hernia | Sexual Dysfunction, PhysiologicalSwitzerland
-
Ann & Robert H Lurie Children's Hospital of ChicagoJohns Hopkins UniversityCompletedInguinal HerniaUnited States
-
Hernia Center RottenburgCompletedUnilateral Inguinal Hernia With Gangrene and ObstructionGermany
-
Helsinki University Central HospitalCompleted
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
General Hospital of LarissaUnknown
-
University Hospital, BordeauxRecruiting