Outcome of Laparoscopic Inguinal Herniorraphy in Children
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|ClinicalTrials.gov Identifier: NCT02310958|
Recruitment Status : Unknown
Verified December 2014 by Johannes Mayr, University Children's Hospital Basel.
Recruitment status was: Enrolling by invitation
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
|Condition or disease||Intervention/treatment|
|Hernia, Inguinal||Procedure: Laparoscopic surgical hernia repair|
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 :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||A Single Center, Retrospective Study of the Outcome of Laparoscopic Inguinal Herniorraphy in Children|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||October 2015|
Children with inguinal hernia
Laparoscopic surgical hernia repair in children aged between 1 day and 16 years
Procedure: Laparoscopic surgical hernia repair
Laparoscopic surgical hernia repair in children
- 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 ]
- 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 ]Occurrence of contralateral hernia after operation of unilateral hernia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310958
|Study Chair:||Sucharitha Geiger||University Childrens Hospital Basel|