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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
Sponsor:
Information provided by (Responsible Party):
Johannes Mayr, University Children's Hospital Basel

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.

Condition or disease Intervention/treatment
Hernia, Inguinal Procedure: Laparoscopic surgical hernia repair

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Johannes Mayr
Investigators
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Study Chair: Sucharitha Geiger University Childrens Hospital Basel
Publications:
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Responsible Party: Johannes Mayr, Professor, University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT02310958    
Other Study ID Numbers: EKNZ2014-247
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Johannes Mayr, University Children's Hospital Basel:
Lapraroscopic surgical procedure
infant
complications
inguinal hernia
hernia recurrence
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal