Clinical trial NCT02310958: Outcome of Laparoscopic Inguinal Herniorraphy in Children
Official title: A Single Center, Retrospective Study of the Outcome of Laparoscopic Inguinal Herniorraphy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Keywords: Lapraroscopic surgical procedure
infant
complications
inguinal hernia
hernia recurrence
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inguinal hernia recurrence
timeFrame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
Secondary outcomes:
measure: postoperative complications (infections)
timeFrame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
measure: length of hospital stay
timeFrame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
measure: type of pain medication and duration of use after surgical procedure
timeFrame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
measure: metachronous hernia occurrence
timeFrame: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months
Other outcomes:
Locations:
Study officials:
affiliation: University Childrens Hospital Basel
name: Sucharitha Geiger
role: STUDY_CHAIR
References:
citation: American College of Surgeons. Surgical Patient Education. http://www.facs.org/patient education.
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