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临床试验/NCT02310958
NCT02310958已完成不适用

A Single Center, Retrospective Study of the Outcome of Laparoscopic Inguinal Herniorraphy in Children

Johannes Mayr0 个研究点目标入组 250 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
主要终点
Inguinal hernia recurrence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Inguinal hernia recurrence

时间窗: Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months

次要结局

  • metachronous hernia occurrence(Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months)
  • postoperative complications (infections)(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(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(Participants will be followed for 3 months up to 51 months after the surgical procedure, an expected average of 27 months)

研究者

发起方
Johannes Mayr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Johannes Mayr

Professor

University Children's Hospital Basel

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